关键词：仿制药；FDA许可；剂型，使用目的；效价；质量
摘 要：Generic drugs are identical, or almost identical, to their branded originals. They may contain very small variations permitted by the FDA. Generic drugs need to be identical or within the satisfactory bioequivalence range of their branded counterparts to be approved by the FDA. They have the same active ingredient(s), dosage form, intended use, potency, quality, and route of administration as the branded drugs. They are available in the market once the patent of the corresponding branded drugs expires, as manufacturers of generics are unable to meet the expenses of developing and marketing a new drug. Generic drugs are generally 50-70 percent less expensive than their branded versions and meet the same standards of effectiveness, quality, and safety. As patents on the branded drugs approach expiration, drug manufacturers can apply to the FDA for approval to develop and sell generic versions of their branded drugs.
目 录：

01. Executive Summary

02. List of Abbreviations

03. Scope of the Report

03.1 Market Overview

03.2 Product Offerings

04. Market Research Methodology

04.1 Market Research Process

04.2 Research Methodology

05. Introduction

06. Overview of Japan

07. Approval Pathway of Generic Drugs in

Japan

07.1 Master File Scheme for Active Ingredients

07.2 Equivalency Review

07.3 Conformity Audit

08. Market Landscape

08.1 Market Overview

08.2 Market Size and Forecast

08.3 Five Forces Analysis

09. Market Segmentation by Product Category

10. Market Segmentation by Therapeutic

Application

11. Buying Criteria

12. Market Growth Drivers

13. Drivers and their Impact

14. Market Challenges

15. Impact of Drivers and Challenges

16. Market Trends

17. Trends and their Impact

18. Vendor Landscape

18.1 Competitive Scenario

18.1.1 Key News

18.1.2 Mergers and Acquisitions

18.2 Market Share Analysis 2014

18.3 Other Prominent Vendors

19. Key Vendor Analysis

19.1 Meiji Seika Pharma

19.1.1 Key Facts

19.1.2 Business Overview

19.1.3 Business Segmentation

19.1.4 Key Product Pipeline

19.1.5 Geographical Presence

19.1.6 SWOT Analysis

19.2 Nichi-Iko Pharmaceutical

19.2.1 Key Facts

19.2.2 Business Overview

19.2.3 Business Strategy

19.2.4 Recent Developments

19.2.5 SWOT Analysis

19.3 Nipro Pharma

19.3.1 Key Facts

19.3.2 Business Overview

19.3.3 Key Product Categories

19.3.4 Recent Developments

19.3.5 SWOT Analysis

19.4 Sawai

19.4.1 Key Facts

19.4.2 Business Overview

19.4.3 Product Segmentation by Revenue 2014

19.4.4 Geographical Presence

19.4.5 Recent Developments

19.4.6 SWOT Analysis

19.5 Teva Pharmaceutical

19.5.1 Key Facts

19.5.2 Business Overview

19.5.3 Business Segmentation

19.5.4 Revenue by Business Segmentation

19.5.5 Revenue Comparison 2012 and 2013

19.5.6 Revenue Segmentation by Geography

19.5.7 Business Strategy

19.5.8 Key Developments

19.5.9 SWOT Analysis

19.6 Towa

19.6.1 Key Facts

19.6.2 Business Overview

19.6.3 Product Portfolio

19.6.4 Geographical Presence

19.6.5 SWOT Analysis

20. Other Reports in this Series