Generic drug companies patents

Ainsworth S J (2005). Biopharmaceuticals Patent expirations are beckoning generic drug companies, but numerous hurdles remain to a profitable business. Chem. Engin. News. 83(23) 21-29. 

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. 

AstraZeneca launched omeprazole in 1988. It is a safe and effective drug for acid reflux, functioning as a proton pump inhibitor. However, the patent has expired and AstraZeneca has to compete against generics. The company developed the active isomer and called it esomeprazole. It was approved by the Mutual Recognition process in Europe in July 2000, and by the US Food and Drug Administration in February 2001. The chemical formulas for omeprazole and esomeprazole are shown below. 

The Amendments provide certain methods by which generic drug manufacturers can obtain approval to market a generic version of a brand-name product. The study s purpose was to provide a more complete picture of how generic drug competition has developed under one method the Amendments established generic entry prior to expiration of the brand-name company s patents on the relevant drug product. This report sets forth the results of the study. ... 

The FDA denied both of these petitions. In each case, the brand-name company had sued the generic applicant for patent infringement, and the citizen petition was resolved by the FDA within the 30-month stay period. Thus, the petition had no effect on the timing of generic drug approval. 

Because some additional uses may only be discovered late in a drug s patent life (or even after the patent has expired), a company may be reluctant to spend the time and money to obtain formal FDA approval of new uses primarily to benefit generic manufacturers. Optimal medical practice, however, calls for access to sound and persuasive data on new indications. Some method needs to be foimd to encourage sponsors to seek new indications during more of a product s patent life and - if possible - beyond. 

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