市場調査報告書：中枢神経系ジェネリック医薬品

Abstract

This important new strategic report from Espicom evaluates the CNS generic drug market and provides detailed assessment and forecast for leading products by value to 2012, patent expiry opportunities to 2015 and competitive evaluation.

Sales of the leading branded drugs used to treat the major CNS conditions could exceed US$70 billion in 2008, with a number of these losing patent protection in the coming years.

This important new strategic report evaluates the CNS generic drug market sector and answers key questions such as:

What is the patent and data exclusivity status of Shire' s ADHD drug Adderall?
What impact on sales of GSK' s Seroxat/Paxil will generic competition have from 2007?
What opportunities exist for Wyeth' s valuable SSNRI Effexor?
What strategies are sanofi-aventis employing in defence of its best selling insomnia treatment Ambien?
Only Exelon is currently available generically for the treatment of Alzheimer' s - what is the potential of the other leading treatments Aricept (Eisai), Razadyne (Janssen) and Namenda (Forest Labs)?
What' s in the pipeline? New branded products that will compete with generics in the future.
Why will sales of Eli Lilly' s Zyprexa remain constant over the next 5 years despite rising generic availability?
What are Dr Reddy' s CNS drug interests?
In 2007, Caraco Pharmaceuticals received 3 ANDA approvals for CNS drugs. What were they and in what dosages?

Providing…

Detailed assessment and forecast for leading products by value to 2012 and beyond
An assessment of patent expiry and challenges
Competitive evaluation
A review of products in late phase research which could impact generic developments
Patent expiry opportunities to 2015

All major sectors

Neurodegenerative Diseases
(Alzheimer' s and Parkinson' s Diseases)
Depression
Multiple Sclerosis
ADHD
Insomnia

Foreword

EXECUTIVE SUMMARY

Attention Deficit Hyperactivity Disorder
- US Patent Expiry for Attention Deficit Hyperactivity Disorder Drugs
The Generic Market for Attention Deficit Hyperactivity Disorder Drugs
- Generic ADHD Drugs Currently Approved in the United States by Company
- FDA ANDA Approvals for Attention Deficit Hyperactivity Disorder Drugs, 2001-2007
Adderall (mixed amphetamine salts)
- Key Markets/Indications/Formulations
  - Adderall XR for ADHD in children aged six to 12 years
  - Adderall XR for ADHD in adults aged 18 years and older
  - Adderall XR for ADHD in adolescents aged 13 to 17 years
- Patents and Data Exclusivity
  - Adderall US Patents
  - Adderall XR US Patents
  - Adderall US Patents
  - Adderall XR US Data Exclusivity
- Generic Competition
  - Barr Pharmaceuticals
    - FDA ANDA Approvals for Adderall
- Market Outlook
  - Adderall XR Sales (2001A-2012E)
Strattera (atomoxetine hydrochloride)
- Patents and Data Exclusivity
  - Strattera US Patents
  - Strattera US Data Exclusivity
- Generic competition
Anexate / Romazicon (flumazenil)
- Generic competition
  - FDA ANDA Approvals for flumazenil
Vyvanse (lisdexamphetamine dimesylate)
- Patents and Data Exclusivity
  - Vyvanse US Patents
  - Vyvanse US Data Exclusivity
- Market Outlook
  - Vyvanse Sales (2007E-2012E)
Concerta (methylphenidate)
- Key Markets/Indications/Formulations
  - Treatment of ADHD in patients aged over six years (18 and 36mg tablets)
  - 54mg extended-release tablet for ADHD
  - 27mg extended-release tablet for ADHD .............................................................................................................................
  - 72mg extended-release for ADHD*
- Further Development
- Patents and Data Exclusivity
  - Concerta US Data Exclusivity
- Generic Competition
- Market Outlook
  - Concerta Sales (2004-2012E)
Daytrana (methylphenidate)
- Key Markets/Indications/Formulations
  - ADHD
- Patents and Data Exclusivity
  - Daytrana US Patents
  - Daytrana US Data Exclusivity
- Market Outlook
  - Daytrana Sales (2006-2012E)
Metadate / Equasym (methylphenidate)
- Key Markets/Indications
  - Attention deficit hyperactivity disorder (ADHD)
- Patents
  - Metadate CD US Patents
- Generic Competition
  - FDA ANDA Approvals for Metadate ER
- Market Outlook
  - Metadate Sales (2004A-2012E)
Ritalin (methylphenidate)
- Key Markets/Indications
  - ADHD - Ritalin LA (extended-release MPH)
- Further Development
- Patents
  - Ritalin LA US Patents
- Generic Competition
  - FDA ANDA Approvals for Ritalin
  - FDA ANDA Approvals for Ritalin SR
- Market Outlook

Depression

US Patent Expiry for Depression Drugs
The Generic Market for Depression Drugs
- Generic Depression Drugs Currently Approved in the United States by Company
- FDA ANDA Approvals for Depression Drugs, 2001-2007
Wellbutrin (bupropion)
- Key Markets/Indications
  - Depression in patients aged 18 years and over
  - Wellbutrin Once-Daily/Wellbutrin XL
    - Depression in patients aged 18 years and over
    - Seasonal major depressive (SMD) episodes in patients with seasonal affective disorder (SAD)
  - Patents and Data Exclusivity
    - Wellbutrin SR US Patents
    - Wellbutrin XL US Patents
    - Wellbutrin XL US Data Exclusivity
  - Generic Competition
    - FDA ANDA Approvals for Wellbutrin
    - FDA ANDA Approvals for Wellbutrin SR
    - FDA ANDA Approvals for Wellbutrin XL
  - Market Outlook
    - Wellbutrin Sales (2001A-2012E)
Celexa (citalopram)
- Licensees
- Markets/Indications
- Generic Competition
  - FDA ANDA Approvals for Celexa
- Market Outlook
  - Cipramil Sales (2001A-2011E)
Cymbalta / Xeristar (duloxetine)
- Key Markets/Indications
  - Depression
  - SUI*
  - DPNP
- Further Development
- Patents and Data Exclusivity
  - Cymbalta US Patents
  - Cymbalta US Data Exclusivity
- Market Outlook
Lexapro (escitalopram)
- Key Markets/Indications
  - Depression (long-term)/panic disorder
  - Generalised anxiety disorder
  - Social anxiety disorder (SAD)
  - Obsessive-compulsive disorder (OCD)
- Further Development
- Patents
  - Lexapro US Patents
- Generic Competition
  - FDA ANDA Approvals for Lexapro
- Market Outlook
  - Lexapro Sales (2002A-2012E)
Prozac (fluoxetine)
- Patents
  - Sarafem US Patents
  - Prozac Weekly US Patents
- Generic Competition
  - FDA ANDA Approvals for Prozac
Luvox (fluvoxamine)
- Key Markets/Indications
  - Depression
  - OCD
  - Social anxiety disorder
  - Immediate-release tablets for the treatment of OCD
- Further Development
- Data Exclusivity
  - Luvox CR US Data Exclusivity
- Generic Competition
  - FDA ANDA Approvals for Luvox
- Market Outlook
  - Luvox Sales (2001A-2012E)
Remeron (mirtazapine)
- Key Markets/Indications
- Patents
  - Remeron Soltab US Patents
- Generic Competition
  - FDA ANDA Approvals for Remeron
  - FDA ANDA Approvals for Remeron Soltab
- Market Outlook
  - Remeron Sales (2003A-2012E)
Seroxat / Paxil (paroxetine)
- Key Markets/Indications
  - Depression
  - Panic disorder
  - OCD
  - Social anxiety disorder (SAD)
  - Generalised anxiety disorder (GAD)
  - Post-traumatic stress disorder
- Paxil CR
  - Depression
  - Panic disorder
  - Premenstrual dysphoric disorder (PMDD)
  - Social anxiety disorder (SAD)
- Patents
  - Paxil US Patents
  - Paxil CR US Patents
  - Paxil oral suspension US Patents
- Generic Competition
  - Sandoz/Apotex/Torpharm/Ivax
  - Pentech/Par Pharmaceutical
  - Endo Pharmaceuticals
  - Synthon
  - Laboratorios Davur/Bentley Pharmaceuticals
  - Others
  - Paxil CR
    - FDA ANDA Approvals for Paxil
    - FDA ANDA Approvals for Paxil CR
- Market Outlook
  - Seroxat/Paxil Sales (2001A-2012E)
Zoloft (sertraline)
- Key Markets/Indications/Formulations
  - Depression
  - Obsessive-compulsive disorder
  - Panic disorder
  - Oral liquid dosage form
  - Post-traumatic stress disorder (PTSD)
  - Pre-menstrual dysphoric disorder (PMDD)
  - Social phobia/social anxiety disorder
- Patents
  - Zoloft US Patents
- Generic Competition
  - FDA ANDA Approvals for Zoloft
- Market Outlook
Effexor (venlafaxine hydrochloride)
- Key Markets/Indications
  - Effexor for depression
  - Effexor XR (once-daily slow-release capsule formulation) for depression
  - Effexor XR for generalised anxiety disorder (GAD)*
  - Effexor XR for prevention of recurrence and relapse of depression
  - Effexor XR for social anxiety disorder (SAD)
  - Effexor XR for depression and GAD in paediatric patients
  - Effexor XR for panic disorder
  - Effexor XR for major depressive disorder (MDD)
- Further Development
- Patents and Data Exclusivity
  - Effexor US Patents
  - Effexor XR US Data Exclusivity
- Generic Competition
  - Lawsuits
  - FDA ANDA Approvals for Effexor
- Market Outlook
  - Effexor Sales (2001A-2012E)

Insomnia

US Patent Expiry for Insomnia Drugs
The Generic Market for Insomnia Drugs
- Generic Insomnia Drugs Currently Marketed in the United States by Company
- FDA ANDA Approvals for Insomnia Drugs, 2001-2007
Rozerem (ramelteon)
- Key Markets/Indications/Formulations
  - 8mg tablets for the long-term treatment of insomnia characterised by difficulty with sleep onset (circadian rhythm sleep disorder) in adults
  - Further Development
- Patents and Data Exclusivity
  - Rozerem US Patents
  - Rozerem US Data Exclusivity
- Market Outlook
  - Rozerem Sales (2002A-2012E)
Ambien (zolpidem)
- Patents/Licensees
- Key Markets/Indications/Formulations
  - Ambien CR C-IV (extended-release formulation)*
- Further Development
- Patents and Data Exclusivity
  - Ambien CR US Patents
  - Ambien US Data Exclusivity
  - Ambien CR US Data Exclusivity
- Generic Competition
  - FDA ANDA Approvals for Ambien
- Market Outlook
  - Stilnox Sales (2001A-2012E)
  - Myslee Sales (2002A-2012E)

Multiple Sclerosis

US Patent Expiry for Multiple Sclerosis Drugs
The Generic Market for Multiple Sclerosis Drugs
- Generic MS Drugs Currently Approved in the United States by Company
- FDA ANDA Approvals for Multiple Sclerosis Drugs, 2001-2007
Copaxone (glatiramer)
- Key Markets/Indications/Formulations
  - Relapsing-remitting multiple sclerosis (RRMS)
  - Prefilled syringe formulation, Copaxone PFS
- Further Development
- Patents
  - Copaxone US Patents
- Generic Competition
- Market Outlook
Avonex (interferon beta 1a)
- Key Markets/Indications
  - The treatment of relapsing MS, after a patient experiences at least 2 clinical events
  - Avonex in a prefilled syringe for the treatment of relapsing MS
  - The treatment of MS patients with a first clinical episode and MRI features consistent with MS
- Market Outlook
  - Avonex Sales (2003A-2012E)
Betaferon (interferon beta 1b)
- Key Markets/Indications
  - Relapsing-remitting multiple sclerosis (1)
  - Secondary-progressive multiple sclerosis
  - Room temperature formulation (25°C) for 24-month storage
  - Prefilled syringe
  - Treatment of patients with first clinical event suggestive of MS
- Further Development
- Lawsuits
- Market Outlook
  - Betaferon/Betaseron sales (2001A-2011E)
Rebif (interferon beta-1a)
- Key Markets/Indications
  - Treatment of relapsing-remitting multiple sclerosis (RRMS)
  - RRMS - 44mcg dose
- Further Development
- Competitor Products/Lawsuits
- Market Outlook
  - Rebif Sales (2001A-2012E)
Tysabri (natalizumab)
- Key Markets/Indications
  - Relapsing-remitting multiple sclerosis
  - Crohn' s disease (moderate-to-severely active)
- Lawsuits
- Sales Forecast
Novantrone (mitoxantrone)
- Key Markets/Indications
- Generic Competition
  - FDA ANDA Approvals for Novantrone
- Market Outlook
  - Novantrone Sales (2003A-2012E)

Neurodegenerative disorders

US Patent Expiry for Alzheimer' s Disease Drugs
US Patent Expiry for Parkinson' s Disease Drugs
The Generic Market for Neurodegenerative Disorders Drugs
- Generic Neurodegenerative Disorder Drugs Currently Approved in the United States by Company
- FDA ANDA Approvals for Alzheimer' s Disease Drugs, 2001-2007

Alzheimer' s Disease Drugs

Aricept (donepezil hydrochloride)
- Key Markets/Indications/Formulations
  - Alzheimer' s disease (mild-to-moderate)
  - Severe AD
- New Formulations
- Further Development
  - Clinical Trial Results - Continuous Treatment Study
- Patents and Data Exclusivity
  - Aricept ODT US Patents
  - Aricept US Patents
  - Aricept, Aricept ODT US Data Exclusivity
- Generic Competition
  - Tentative approvals for donepezil ANDAs
- Market Outlook
  - Aricept Sales (2001A-2012E)
Razadyne / Reminyl (galantamine)
- Key Markets/Indications/Formulations
  - Tablet formulation for AD
  - Solution formulation for AD
  - Synthetic oral solution for AD*
  - Extended-release formulation for mild-to-moderate AD
- Patents and Data Exclusivity
  - Razadyne tablets and oral solution
  - Razadyne ER
  - Razadyne ER US Data Exclusivity
- Generic Competition
  - Tentative approvals for galantamine ANDAs
- Market Outlook
  - Reminyl Sales (2004A-2012E)
Namenda (memantine)
- Key Markets/Indications
  - Moderatlye-severe to severe Alzheimer' s disease
  - Moderate Alzheimer' s disease.
- Further Development
- Patents and Data Exclusivity
  - Namenda US Patents
  - Namenda US Data Exclusivity
- Generic Competition
- Market Outlook
Exelon (rivastigmine)
- Key Markets/Indications
  - Mild-to-moderately severe AD
  - Mild-to-moderately severe dementia in patients with idiopathic Parkinson' s disease (PD)
  - Exelon TDS (transdermal patch for patients with mild-to-moderately severe AD)
  - Exelon TDS (transdermal patch for patients with mild-to-moderate PD dementia)
- Further Development
- Patents and Data Exclusivity
  - Exelon capsules and solution US Patents
  - Exelon extended release transdermal film US Patents
  - Exelon extended release transdermal film US Data Exclusivity
- Generic Competition
  - FDA ANDA Approvals for Exelon
- Market Outlook
  - Exelon Sales (2001A-2012E)

Parkinson' s Disease

DOPS (droxidopa)
Comtan (entacapone)
- Key Markets/Indications
  - Parkinson' s disease
- Further Development
- Patents
  - Comtan US Patents
- Patents/Generic Competition
- Market Outlook
Sifrol / Mirapex (pramipexole)
- Key Markets/Indications
  - PD
  - Advanced idiopathic PD combined with levodopa when the effect of levodopa wears off or becomes inconsistent over the course of the disease
  - Monotherapy for the treatment of the signs and symptoms of idiopathic early PD*
  - Moderate-to-severe restless legs syndrome (RLS)
- Patents and Data Exclusivity
  - Mirapex US Patents
  - Mirapex US Data Exclusivity
- Generic Competition/Lawsuits
  - FDA ANDA Approvals for Mirapex
- Market Outlook
  - Sifrol/Mirapex/Mirapexin Sales (2001A-2012E)
Azilect (rasagiline)
- Markets/Indications
  - Parkinson' s disease (as monotherapy and as adjunct in moderate-to-advanced PD)
- Patents and Data Exclusivity
  - Azilect US Patents
  - Azilect US Data Exclusivity
- Market Outlook
ReQuip (ropinirole)
- Key Markets/Indications
  - Parkinson' s disease (immediate-release tablets, three-times daily)
  - Restless legs syndrome (RLS; immediate-release tablets, three-times daily)
  - Parkinson' s disease (prolonged-release tablets, once-daily)
- Further Development
- Patents and Data Exclusivity
  - ReQuip US Patents
  - ReQuip US Data Exclusivity
- Generic Competition
- Market Outlook
  - ReQuip/Adartel Sales (2001A-2012E)
Neupro (rotigotine)
- Key Markets/Indications/Formulations
  - Signs and symptoms of early-stage idiopathic PD*
  - Advanced-stage PD in combination with levodopa
- Further Development
- Patents and Data Exclusivity
  - Neupro US Patents
  - Neupro US Data Exclusivity
- Market Outlook

Schizophrenia

US Patent Expiry for Schizophrenia Drugs
The Generic Market for Schizophrenia Drugs
Abilify (aripiprazole)
- Key Markets/Indications/Formulations
  - Schizophrenia - once-daily oral tablet for short-term use (dose range 10 to 30mg)
  - Schizophrenia - oral solution
  - Long-term treatment of maintaining stability in patients with schizophrenia
  - Acute bipolar mania including manic and mixed episodes associated with BPD - oral formulation
  - Abilify Injection for intramuscular use in the control of agitation in adults with schizophrenia or bipolar mania
- Further Development
- Patents and Data Exclusivity
  - Abilify US Patents
  - Abilify US Data Exclusivity
Zyprexa (olanzapine)
- Key Markets/Indications
  - Long-term maintenance treatment of schizophrenia and the treatment of co-morbid depression, or depression that may occur with schizophrenia
  - Bipolar disorder (BPD)
  - Orally-disintegrating Tablets (ODT)*
  - Long-term therapy and maintenance of treatment response of schizophrenia
  - Zyprexa powder solution for injection for rapid control of agitation and disturbed behaviours in schizophrenics
  - Combination therapy with either lithium or Depakote (divalproex) for the treatment of acute manic episodes associated with BPD
  - Long-term prevention of relapsing into manic, mixed manic or depressive episodes, in patients with BPD (maintenance of BPD)
  - Zyprexa IntraMuscular for controlling the effects of acute agitation in patients suffering with schizophrenia and bipolar mania
  - Granule formulation
- Further Development
- Patents and Data Exclusivity
  - Zyprexa US Patents
  - Zyprexa Zydis US Patents
  - Zyprexa, Zyprexa ODT US Data Exclusivity
  - Zyprexa Intramuscular Injection US Data Exclusivity
- Generic Competition
  - Tentative approvals for olanzapine ANDAs
- Market Outlook
Invega (paliperidone)
- Key Markets/Indications/Formulations
  - Schizophrenia
- Further Development
- Patents and Data Exclusivity
  - Invega US Patents
  - Invega US Data Exclusivity
- Market Outlook
  - Invega Sales (2007A-2012E)
Seroquel (quetiapine fumarate)
- Key Markets/Indications/Formulations
  - Schizophrenia
  - Seroquel (quetiapine) 50% Fine Granules for schizophrenia
- Further Development
- Patents and Data Exclusivity
  - Seroquel US Patents
  - Seroquel XR US Patents
  - Seroquel US Data Exclusivity
  - Seroquel ER US Data Exclusivity
- Market Outlook
  - Seroquel Sales (2002A-2012E)
Risperdal (risperidone)
- Key Markets/Indications/Formulations
  - Treatment of schizophreniform disorders
  - Oral solution for behavioural disturbances
  - Once-daily dosing regimen (tablet and solution)
  - Behavioural and psychological symptoms of dementia (BPSD)
  - Delaying relapse in the long-term treatment of schizophrenia
  - Short-term treatment of acute manic or mixed episodes associated with bipolar I disorder*
  - Fast-dissolving oral formulation (1)
  - Irritability associated with autistic disorder in children and adolescents aged five to 16 years*
  - Risperdal Consta
- Further Development
- Patents and Data Exclusivity
  - Risperdal US Patents
  - Risperdal Consta US Patents
  - Risperdal US Data Exclusivity
  - Generic Competition
- Market Outlook
  - Risperdal Sales (2001A-2012E)
Dogmatyl (sulpride)
- Key Markets
- Market Outlook
  - Dogmatyl Sales (2002A-2012E)
Ceredist (taltireline)
- Key Markets/Indications/Formulations
  - Ceredist Tablets 5 for the treatment of spinocerebellar degeneration
- Market Outlook
  - Ceredist Sales (2002A-2012E)
Champix (varenicline)
- Key Markets/Indications/Formulations
  - Smoking cessation
- Patents and Data Exclusivity
  - Chantix US patents
  - Chantix US Data Exclusivity
- Market Outlook
Geodon (ziprasidone mesylate)
- Key Markets/Indications/Formulations
  - Schizophrenia
  - Intramuscular formulation
  - Bipolar mania
- Further Development
- Patents
  - Geodon US Patents
- Generic Competition
  - Tentative approvals for ziprasidone ANDAs
- Market Outlook
  - Geodon/Zeldox Sales (2001A-2012E)

Other CNS drugs

Epilepsy

US Patent Expiry for Epilepsy Drugs
The Generic Market for Epilepsy Drugs
- Generic Epilepsy Drugs Currently Marketed in the United States by Company
- FDA ANDA Approvals for Epilepsy Drugs, 2001-2007
Carbatrol (carbamazepine)
- Patents
  - Carbatrol US Patents
  - FDA ANDA Approvals for carbamazepine
- Generic Competition
  - Tentative approvals for carbamazepine ANDAs
Depakote (divalproex sodium)
- Key Markets/Indications
  - Manic episodes of bipolar disorder (BPD)*
  - Prevention of migraine
  - Complex partial seizures*
  - Depacon (sodium valproate for injection) for temporary treatment of certain types of epilepsy
  - Depakote ER Tablets 500mg (controlled-release) for migraine prevention
  - Depakote ER Tablets 500mg for sole and adjunctive therapy to treat complex partial seizures and simple and complex absence seizures in adults with epilepsy
  - Depakote ER tablets for sole and adjunctive therapy to treat complex partial seizures in isolation, or in association with other types of seizures, including simple and complex absence seizures in children, aged ten years and above, with epilepsy
  - Depakote ER tablets for the treatment of acute manic or mixed episodes associated with BPD, with or without psychotic features
- Patents and Data Exclusivity
  - Depakote US Patents
  - Depakote ER US Patents
  - Depakote ER US Data Exclusivity
- Generic Competition
  - Tentative approvals for divalproex ANDAs
- Market Outlook
  - Depakote Sales (2003A-2012E)
Myonal (eperisone)
- Key Markets/Indications
- Market Outlook
  - Myonal Sales (2002A-2012E)
Neurontin (gabapentin)
- Key Markets/Indications/Formulations
  - Adjunctive therapy in epilepsy for adults and children aged 12 and over
  - Adjunctive therapy in the treatment of partial seizures with and without secondary generalisation in adults
  - Adjunctive therapy in the treatment of partial seizures in paediatric patients
  - Neuropathic pain
- Further Development
- Patents
  - Neurontin US Patents
- Generic Competition
  - FDA ANDA Approvals for Neurontin
- Market Outlook
  - Neurontin Sales (2001A-2012E)
Lamictal (lamotrigine)
- Key Markets/Indications
  - Epilepsy (as a monotherapy)
  - Generalised seizures associated with Lennox-Gastaut Syndrome
  - Long-term maintenance treatment of bipolar I disorder (BPID)
  - Add-on therapy in partial seizures in children aged two years and over
  - Monotherapy for treatment of partial seizures in patients aged 16 years and older
  - Primary generalised tonic-clonic (PGTC) seizures in children aged two years and older, as well as in adults
- Further Development
- Patents and Data Exclusivity
  - Lamictal US Patents
  - Lamictal CD US Patents
  - Lamictal, Lamictal CD US Data Exclusivity
- Generic Competition
  - FDA ANDA Approvals for Lamictal
- Market Outlook
  - Lamictal Sales (2001A-2012E)
Keppra (levitracetam)
- Key Markets/Indications
  - Epilepsy (including children aged 16 years and older)
  - Epilepsy (intravenous formulation)
  - Epilepsy (adjunctive therapy in the treatment of partial-onset seizures, with or without secondary generalisation, in children aged four years and older)
  - Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy
  - Monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly-diagnosed epilepsy
  - Adjunctive therapy for the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy
  - 1,000mg tablet for the treatment of epilepsy
- Further Development
- Patents and Data Exclusivity
  - Keppra US Patents
  - Keppra US Data Exclusivity
  - Keppra injectable IV infusion US Data Exclusivity
- Generic Competition
- Market Outlook
  - Keppra Sales (2001A-2012E)
Lyrica (pregabalin)
- Key Markets/Indications/Formulations
  - Adjunctive treatment of partial epileptic seizues
  - Neuropathic pain
  - Generalised anxiety disorder (GAD)
  - Central neuropathic pain
  - Management of fibromyalgia
- Further Development
- Patents and Data Exclusivity
  - Lyrica US Patents
  - Lyrica US Data Exclusivity
- Market Outlook
  - Lyrica Sales (2004A-2012E)
Topamax (topiramate)
- Key Markets/Indications/Formulations
  - Add-on treatment for adults with POS
  - Topamax Sprinkles, for use as adjunctive therapy for the treatment of adults with POS
  - Topamax to treat POS as add-on therapy in paediatric patients aged two-16 years
  - Topamax Tablets and Topamax Sprinkle Capsules as add-on treatment for primary generalised TCS in adults and paediatric patients
  - Topamax Tablets and Sprinkle Capsules as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome*
  - Epilepsy 200mg dose
  - Migraine and headache prophylaxis in adults
  - Topamax Tablets and Sprinkle Capsules as initial monotherapy in patients ten years of age and older with partial-onset or primary generalised tonic-clonic seizures
- Further Development
- Patents and Data Exclusivity
  - Topamax, Topamax Sprinkle US Patents
  - Topamax, Topamax Sprinkle US Data Exclusivity
- Generic Competition
- Market Outlook
  - Topamax Sales (2001A-2012E)
Depakene (valproic acid)
- Key Markets/Indications/Formulations
  - Epilepsy
  - Acute mania
  - Manic disorders and the manic phase of bipolar disorder
- Patents
- Generic Competition
  - FDA ANDA Approvals for Depakene
- Market Outlook
  - Depakene Sales (2002A-2012E)
Zonegran (zonisamide)
- Key Markets/Indications/Formulations
  - 100mg dosage as an adjunctive therapy for partial (focal) seizures in adults with epilepsy*
- Further Development
- Generic Competition
  - FDA ANDA Approvals for Zonegran
- Market Outlook
  - Excegran Sales (2002A-2012E)

Pain

Neuropathic Pain (NP)
Diabetic peripheral neuropathy (DPN)
Cancer neuropathic pain (CNP)
HIV neuropathic pain (HIVNP)
Postherpetic neuralgia (PHN)
- US Patent Expiry for Pain Drugs
The Generic Market for Pain Drugs
- FDA ANDA Approvals for Pain Drugs, 2001-2007
Duragesic (fentanyl)
- Key Markets/Indications/Formulations
- Chronic severe pain
- Management of chronic intractable pain due to cancer*
- Treatment of chronic intractable pain (not just for cancer)
- Duragesic 12 CII, for moderate to severe chronic pain (12 mcg/hour)
- Ionsys (patient-activated transdermal system 40mcg/dose) for the management of acute moderate-to-severe postoperative pain, for use by adults, in a hospital setting only*
- Generic Competition
  - FDA ANDA Approvals for Duragesic
- Market Outlook
  - Duragesic Sales (2001A-2012E)
Durotep (fentanyl)
- Key Markets/Indications/Formulations
  - Durotep Patch for persistent cancer pain
- Market Outlook
  - Durotep Sales (2002A-2012E)
Matrifen(fentanyl)
- Key Markets/Indications/Formulations
  - Severe chronic pain
- Market Outlook
  - Matrifen Sales (2006A-2012E)
Toradol (ketorolac trometamol)
- Generic Competition
- Market Outlook
  - Toradol Sales (2001A-2012E)
Xefo (lornoxicam)
- Key Markets/Indications/Formulations
- Market Outlook
OxyContin (oxycodone)
- Key Markets/Indications/Formulations
  - Moderate-to-severe cancer pain - OxyContin
  - Moderate-to-severe cancer pain - OxyNorm (an oral immediate-release formulation)
- Patents
  - Oxycontin US Patents
- Generic competition
  - Branded products containing oxycodone
- Market Outlook
  - OxyContin Sales (2002A-2012E)

Migraine

US Patent Expiry for Migraine Drugs
The Generic Market for Migraine Drugs
Relpax (eletriptan)
- Key Markets/Indications/Formulations
- Patents
  - Relpax US Patents
- Market Outlook
  - Relpax Sales (2001A-2012E)
Maxalt (rizatriptan)
- Key Markets/Indications/Formulations
  - Migraine and associated symptoms
  - Adolescent migraine sufferers
- Patents
  - Maxalt US Patents
  - Maxalt-MLT US Patents
- Generic Competition
  - Tentative approvals for rizatriptan ANDAs
- Market Outlook
Imigran / Imitrex (sumatriptan)
- Key Markets/Indications
- Further Development
- Patents
  - Imitrex US Patents
- Generic Competition
- Market Outlook
  - Imigran/Imitrex Sales (2001A-2012E)
Zomig (zolmitriptan)
- Patents
  - Zomig US Patents
  - Zomig-ZMT US Patents

Branded Company CNS R&D Projects

Company Profiles

Apotex
- CNS Products
  - Apotex: FDA ANDA Approvals for CNS drugs, 2002-07
  - Novex Pharma ANDA Approvals, 2002-05
  - TorPharm ANDA Approvals, 2002-05
- Sertraline hydrochloride
- Financial results
- Major developments
  - Apotex acquires Lareq Pharma
  - Topgen
  - Beijing Med-Pharm
Litigation
- Abbott
Aurobindo Pharma
- CNS Products
  - Aurobindo Pharma: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent Product Approvals
  - Sumatriptan (tentative)
  - Citalopram (South Africa)
  - Zolpidem
  - Sertraline
  - Sertraline (South Africa)
  - Citalopram (Canada)
Financials
- Major Developments
  - Mergers, Acquisitions and Agreements
  - Pharmacin International
Barr Pharmaceuticals
- CNS Products
  - Oxycodone/ibuprofen tablets
  - Pramipexole tablets (tentative)
  - Cabergoline
  - Galantamine hydrobromide (tentative)
  - Risperidone (tentative)
  - Sertraline (Pliva)
    - Barr Laboratories: FDA ANDA Approvals for CNS drugs, 2002-07
- Financial results
- Major developments
  - Litigation
  - Barr initiates dexmethylphenidate patent challenge
  - Novartis sues Barr over methylphenidate patent challenge
  - Barr and Par settle diazepam patent challenge with Valeant
  - Barr withdraws from Zyprexa Zydis patent challenge
  - Barr and Lilly voluntarily dismiss Prozac Weekly patent litigation
Bedford Laboratories
- CNS Products
  - Bedford Laboratories: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent Product Approvals
  - Fosphenytoin
Caraco Pharmaceutical Laboratories
- CNS Products
  - Caraco Pharmaceutical Laboratories: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent Product Approvals
  - Zolpidem
  - Paroxetine
  - Modafinil (Tentative)
  - Phentermine
  - Oxcarbazepine
  - Lamotrigine (tentative)
  - Escitalopram (tentative)
- Financial results
Major Developments
- Litigation
  - Caraco gains tramadol / acetaminophen appellate court ruling
Dr Reddy' s Laboratories
- CNS products
  - Dr Reddy' s: FDA ANDA Approvals for CNS Drugs, 2002-07
- Zolpidem
- Financial results
  - Major developments
  - Mergers, acquisitions & agreements
  - Sygnis
  - Litigation
  - Sertraline action
Impax Laboratories
- CNS Products
  - Impax Laboratories: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent Product Approvals
  - Oxymorphone ANDA acceptable for filing
  - Venlafaxine (tentative)
  - Alprazolam
  - Bupropion hydrochloride extended-release
- Financials
- Major Developments
  - Mergers, Acquisitions and Agreements
  - Intec and Impax to collaborate on CNS drug
  - Litigation
  - Oxymorphone
  - Oxycodone
  - Divalproex
  - Wellbutrin XL
  - Wyeth files venlafaxine lawsuit against Impax
  - Impax and Shire reach Adderall XR settlement & carbamazepine deal
Interpharm
- CNS Products
  - Interpharm ANDA Approvals, 2002-07
- Financials
- Major Developments
  - Mergers, Acquisitions and Agreements
  - Watson Laboratories
  - Litigation
  - Forest and Merz file second suit against memantine challengers
KV Pharmaceutical
- CNS Products
  - KV Pharmaceuticals / Ethex: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent Product Approvals
  - Morphine
- Financial Results
Major Developments
- Mergers, Acquisitions and Agreements
  - Gedeon Richter
  - Strides Arcolab
  - Glenmark Pharmaceuticals
Mallinckrodt
- CNS Products
  - Mallinckrodt / Tyco Healthcare: FDA ANDA Approvals for CNS Drugs, 2002-07
- Major Developments
  - Mergers, Acquisitions and Agreements
  - Zydus Cadila
Mikart
- CNS Products
  - Mikart: FDA ANDA Approvals for CNS Drugs, 2002-07
Mylan
- CNS Products
  - Mylan: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent product approvals
  - Lamotrigine
  - Topiramate capsules (tentative)
  - Paroxetine ER
  - Fluoxetine capsules
  - Zolpidem
  - Divalproex ER (tentative)
  - Companies gain sertraline hydrochloride approvals, as Teva takes legal action
- Financial results
- Major developments
  - Mergers, acquisitions and agreements
  - Mylan agrees to acquire Merck Generics for EUR 4 billion
  - Litigation
  - Mylan and GSK settle generic Paxil dispute
  - UCB settles levetiracetam patent litigation
Perrigo
- CNS Products
  - Perrigo: FDA ANDA approvals for CNS Drugs, 2002 - 2007
- Recent product approvals
  - Nicotine gum
  - Sertraline
- Financial results
Ranbaxy Laboratories
- CNS Products
  - Ranbaxy: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent product approvals
  - Galantamine (tentative)
  - Hydrocodone bitartrate+acetaminophen
  - Zolpidem
  - Sertraline
- Financial results
Roxane Laboratories
- CNS Products
  - Roxane Laboratories: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent Product Approvals
  - Oxcarbazepine
  - Sertraline
Sandoz
- CNS Products
  - Sandoz: FDA ANDA Approvals for CNS Drugs, 2002-07
  - Eon Labs: FDA ANDA Approvals for CNS Drugs, 2002-05
  - Geneva Pharmaceuticals: FDA ANDA Approvals for CNS Drugs, 2002-03
  - Lek: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent product approvals - Lek
  - Zolpidem
- Financial results
- Major developments
  - Litigation
  - Abbot sues Zydus and Sandoz over divalproex
  - Atomoxetine patent litigations launched
Sun Pharmaceutical Industries
- CNS Products
  - Sun Pharmaceutical Laboratories: FDA ANDA Approvals for CNS Drugs, 2002-07
  - Taro Pharmaceutical Industries: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent Product Approvals
  - Carbidopa/levodopa
  - Galantamine (tentative)
  - Rivastigmine
  - Oxcarbazepine
  - Divalproex (tentative)
- Financials
- Major Developments
  - Mergers, Acquisitions and Agreements
  - Able Laboratories
  - Taro Pharmaceutical Industries
  - Litigation
  - Venlafaxine
  - Carbidopa / levodopa / entacapone
  - Rivastigmine
  - Memantine
Teva Pharmaceutical Industries
- CNS products
  - Teva: FDA ANDA Approvals for CNS Drugs, 2002-07
  - IVAX: FDA ANDA Approvals for CNS Drugs, 2002-07
  - Gensia Sicor Pharmaceuticals / Sicor: FDA ANDA Approvals for CNS Drugs, 2003-07
  - Goldline Laboratories / Zenith Goldline: FDA ANDA Approvals for CNS Drugs, 2002-05
- Recent product approvals
  - Risperidone (UK)
  - Oxcarbazepine
  - Ropinirole (tentative)
  - Teva gains positive olanzapine opinion
  - Zolpidem
  - Cabergoline
  - Alprazolam ER tablets
  - Dexmethylphenidate
- Financial results
- Major developments
  - Litigation
  - Appeals court favours Pfizer over Teva in gabapentin case
  - Dr Reddy' s and Teva settle sertraline action
  - Appeals court upholds escitalopram decision
  - Biovail reaches comprehensive settlement related to Wellbutrin XL
United Research Laboratories / Mutual Pharmaceutical Company
- CNS Products
  - URL / Mutual: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent Product Approvals
  - Zolpidem
- Major Developments
  - Litigation
  - Eisai
Watson Pharmaceuticals
- Andrx
- CNS Products
  - Watson: FDA ANDA Approvals for CNS Drugs, 2002-07
  - Andrx: FDA ANDA Approvals for CNS Drugs, 2002-07
- Recent product approvals
  - Oxycodone/ibuprofen
  - Fentanyl
  - Zolpidem
  - Sertraline
- Financial results
- Major developments
  - Litigation
  - Bupropion XL

中枢神経系ジェネリック医薬品：2012年までの見通しと機会

CNS Generic Drugs: Prospects and Opportunities to 2012

Abstract

Providing…

All major sectors

Table of Contents

EXECUTIVE SUMMARY

Depression

Insomnia

Multiple Sclerosis

Neurodegenerative disorders

Alzheimer' s Disease Drugs

Parkinson' s Disease

Schizophrenia

Other CNS drugs

Epilepsy

Pain

Migraine

Branded Company CNS R&D Projects

Company Profiles