日本におけるスタチン市場

Abstract

The reports from the "All in Japan" series provide overview and concise up-to-date description of each product from a specific product or therapeutic category approved in Japan. All in Japan: Statins report is the largest so far in the All in Japan series, a long awaited regulatory compendium on the top selling drug class in Japan. The report cross-examines the Japanese statin regulatory market in terms of therapeutic, formulation, registration and regulatory classification along with full listing of approval, pricing and market timelines and even manufacturer premises. With clear tabulated format, the explosion of pravastatin generic approvals in 2003 concomitantly with the patent expiry of Sankyo's blockbuster Mevalotin? cannot go unnoticed in this report. The pravastatin scenario has had a domino effect on simvastatin manufacturers and/or their respective marketing agents in filing for generic approval, culminating in 44 "me too" registered statin generics - representing a staggering 86% of the total statin drugs available today on the Japanese prescription registry.

Key Features

• Unprecedented full regulatory findings on all 51 registered statin prescription medicines currently available in Japan
• Key package insert information and formulation specification and precise drawn-to-scale graphical representation of the 51 products for quick referencing
• Expert generated statistical and graphical findings for convenient regulatory and strategic research use
• Tabulated easy-to-find alphabetical listing previously unavailable in English

Analysis Highlights

Although New Chemical Entity statins innovated from Japan pharma will continue to buoy the dyslipidemia market, with a 55% stake of all Japan registered statins, pravastatin continues to be the mainstay. An obvious concern for new entrants is an over-saturation of Japan registered statins generics, and expiry of the Mevalotin? patent in July 2003 saw the floodgates open with Japan registered statins pravastatin and simvastatin generic numbers climbing to 27 and 17 respectively - a 44 strong generic "tsunami", comprising of 86% of the total Japan registered statins market.

With the Japanese prescription registry being expanded to pitavastatin calcium and increased availability of adjunctive therapies, no doubt this will lead to major improvements in the treatment of more 'difficult-to-treat' patients.

Practical Use to the Reader

• To champion opportunities in the Statin market, strengthen internal positioning of dyslipidemia pipeline portfolio, and identify lucrative licensing and co-marketing opportunities - this report is a must for product managers wanting to enter the Japanese market
• Regulatory affairs personnel seeking regulatory approval for their cardiovascular product in Japan - an indispensable information source particularly for benchmarking their own product with the Japanese market in terms of approval timeline and registration feasibility
• Statin marketing specialists - can evaluate (or reevaluate) their Japan strategy by having access to regulatory information normally unavailable elsewhere
• Invaluable reference material to confirm or refute current concerns arising from your organization's regulatory strategy to register a statin generic in Japan.

Table of Contents

1. Introduction

2. Type/generations of statins

• Table 1. Generations of statins

3. Statins products approved in Japan

• Table 2. Approval classification of the prescription medicinal products
• Table 3. Individual statin products approved in Japan

4. Approval statistics for the statin products in Japan

• Table 4. Approval statistics for the statin products
• Figure 1. Approval statistics for the generations of statin products approved in Japan
• Figure 2. Approval statistics for the approval classes of statin products approved in Japan

5. Appendices

• Disclaimer and Publisher Information