Market exclusivity

Market Exclusivity Newly Approved Drug Substances... 

A developer may apply to have a new drug designated. Designation entitles the developers to avail themselves of the same type of incentives in terms of supports and market exclusivity that apply to human orphan products. 

The generic manufacturer may not place a copy of either the original product or the new pharmaceutical form on the market for a period of 11 years after the approval of the original product (i.e. 10 years + 1 year added to the global market exclusivity period, because of new indications). 

Pharma cannot sustain the double-digit growth demanded by investors. When market exclusivity ends, revenues drop by 50-80%. 

Drugs Under Patent. This book [77] is a cross-referenced listing of over 2500 drugs covered in the United States under patent law and marketing exclusivity provisions of the Waxman-Hatch Act. Eight indexes provide market and patent status information by company, trade name, generic name, expiration date, dosage form, exclusivity code, patent number, and NDA number. Updated annually, this book is available commercially. 

Policy on Period of Marketing Exclusivity for Newly Approved Drug Products with Enantiomer Active Ingredients Request for Comments, (1997) Docket No. 97N-0002. 

An FDA designation for a therapy developed to treat a rare disease (one which afflicts less than 200,000 people in the United States). Because there are fewer financial incentives for drug companies to develop these therapies, the U.S. government offers additional incentives to the companies (tax advantages and extended marketing exclusivity) that develop these drugs. 

The business model of the innovative pharmaceutical industry is to transform the results of basic medical research into products that provide health benefits to the patient. This model is characterized by a high risk of failure in the development of new products, coupled with the benefit of market exclusivity for a number of years if a product can be successfully developed and is approved by the regulatory agencies. Only very few chemical entities complete the development process from drug discovery to a commercial product. But those products that do reach the marketplace have to yield sufficient financial rewards to assure that the... 

The data do not establish, however, whether even more appropriate patent challenges might have been brought if the period of generic market exclusivity was longer than 180 days. 

Chapter 5 180-Day Marketing Exclusivity Under the Hatch-Waxman Amendments... 

Definition of the Court As Used in the 180-Day Marketing Exclusivity Provision... 

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