Generics patent status

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. 

Polyesters, specifically polylactides and poly(lactide-co-glycolide)s have played a critical role in the development of polymer-based CR technologies. The biocompatibility and the well-established safety profiles of PLA and PLGA polymers have made them the polymer of choice for CR applications. However the off-patent status of these polymers makes them freely available for research in industry as well as academia. This has led to a vast number of patents covering various applications of these polymers within the drug delivery sector. Due to these issues, very limited scope remains to utilize these polymers to reformulate generic, off-patent drugs. 

Another hot topic associated with product approvals is market exclusivity (statutory protection from competition in the form of generic copies). Market exclusivity terms (time period allocations) for registered drugs are linked to U.S. patent status. When a new chemical entity is first approved for marketing in the United States, its developer has the option to apply for a term restoration to be granted on... 

This legislation represented a compromise that also allowed easier FDA approval for generic drugs after patent expiration. The law also allows two types of exclusivity not related to patent status—a 5-year exclusivity for new chemical entities not eligible for a patent and a 3-year exclusivity for new uses of approved chemical entities. TMs appendix discusses the 3-year exclusivity in greater detail in the following section. 

As indicated above, the status of generic versions of both pre-1962 and post-1962 new drugs was settled by Congress in the Drug Price Competition and Patent Term Restoration Act of 1984. That statute will be discussed in greater detail below. 

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