Patent exclusivity

The 505(b)2 application raises some patent issues beyond the scope of this book but that need to be considered if the option is under review. Generally, the 505(b)2 provides a patent exclusivity if (and only if) the applicant conducts one or more critical studies in support of the application. If all support studies are referenced from published literature of Agency findings, the patent exclusivity will not apply. While the definition of critical studies is subject to some interpretation, in this context, it most commonly refers to studies that demonstrate the link between the applicant drug and other formulations used in outside studies or previously approved by the Agency. These studies fall under the headings of Bioequivalence (BE) or Bioavail-... 

In addition, the formal granting of the three-year patent exclusivity requires the formal notification of the original patent holder of the approval of a 505(b)2 NDA. 

Therapeutic alternatives Adverse Drug Reactions (ADRs) Disease progression Remaining patent exclusivity... 

Patent exclusivity enables a company to recoup its research and development investment and make an appropriate profit. Once patents expire, generic competition greatly erodes sales, although generic competition is frequently delayed by the portfolio of patents usually created by a company. It will be apparent that because of the enormous costs of drug development and the need to recoup these costs, all drugs taken to the marketplace should have some form of patent protection, even if... 

The example of Voltarol Retard, cited in the preceding section, is one of a company which has developed an innovative drag, acting to protect its franchise in that product when patent expiry draws near. Every proprietary product eventually loses its patent exclusivity (usually 20 years after the patent was applied for or granted) and it is then open to any other manufacturer to manufacture and sell the same drag, perhaps under its own brand name. It is, of course, necessary to obtain a license to manufacture and market the... 

As presented in Table 2, many of these early biotechnology products have reached the end of their period of patent exclusivity [4-9], Thus, it is appropriate to now consider the next steps in the life cycle of these products as potential generic drugs. 

For Generic Companies The act provided access to certain innovator information without the threat of legal action via patent infringement suits (safe harbor provisions), allowing generics the opportunity to prepare for market introduction prior to the expiration of patent/exclusivity terms. This effectively limited the period of innovator exclusivity to the statutory timelines. 

A handful of manufacturers, faced with the loss of patent exclusivity, moved to sell their once-prized blockbusters— including Claritin and Prilosec—over-the-counter, without a... 

Claritin s patent exclusivity. Its CEO retired under fire in late 2002. So it s not clear how much trouble Merck would be buying, along with full rights to Zetia. 

David Schetter, University of California, Irvine Were patents exclusive to companies outside the consortia Was there a university patent agreement ... 

Qther interesting features of the Canadian system include its 1998 mutual recognition agreement with the EU, prohibition of prescription drug advertising to consumers, a 20-year patent exclusivity period, and the establishment of the PMPRB to ensure fair pricing of medications. ... 

In addition to patent exclusivity, an innovator may help preserve its market share for a new drug through FDA exclusivity. FDA exclusivity does not guarantee the innovator an exclusive right to market the drug, but it does operate to block approval of ANDAs for... 

The FDA provides notice of the innovator s FDA and patent exclusivity by publishing information regarding exclusivity in the FDA Approved Drugs Product List (the Orange Book ). The Patent and Exclusivity Appendix to the list of approved products provides details regarding the expiry dates of all types of FDA exclusivity (including pediatric exclusivity) and the expiry dates of patents for each approved product. 

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