The PTO has granted an interim term extension for U.S. patent No. 4,603,123. The patent claims the active ingredient piroxicam betadex that is used in Brexidol (R). A New Drug Application (NDA) for Brexidol (R) has been filed with the FDA and is currently undergoing regulatory review.
Brexidol (R) is an NSAID that is believed to work by blocking the production of a prostaglandin which the body produces in response to injury or certain diseases. This prostaglandin would otherwise go on to cause swelling, pain and inflammation.
Interim Patent Extension
The term of a patent is extendable if delays in production were caused by delays in a regulatory approval process. 35 U.S.C. 156(d)(5) provides for an interim extension if a patent is about to expire and the patentee believes that the regulatory review period will exceed the term of the patent. The application for an interim extension may not be filed until the six month period prior to the expiration of the patent, but must be filed at least 15 days before the expiration of the patent. An applicant may not apply for more than four interim extensions and each extension may be for no more than one year.