Case Studies


What is Buspar?

Buspar, contains the active ingredient Buspirone, is a medication primarily used to treat anxiety disorders, particularly generalized anxiety disorder. It was launched by Bristol-Myers Squibb (BMS) in the Unites States in 1986 and lost its exclusivity in 2001.

Buspar patency extension:

In September of 1998, The FDA tentatively approved the ANDA by Mylan to market a generic version of buspirone tablets as soon as the patents of Buspar expires which were expected at 11:59 p.m. on November 21, 2000.

Mylan started to manufacture its generic buspirone and shipped its trucks to start the distribution by November 22, 2000.

In an unexpected move by Bristol-Myers Squibb only 11 hours before the exclusivity was to expire the company obtained a new patent of active metabolite of buspirone.

The FDA immediately listed the new patient in the Orange Book and informed Mylan on the new patent. As a result, a patent infringement suit brought by Bristol-Myers Squibb.

Surprisingly, It was found that the new patent was a misrepresentation to the FDA and the BMS got into troubles ended up with delisting the patent from the Orange Book.

The end result is that Bristol-Myers Squibb successfully held the competitors up by about for months.

By figures, $600 million of Buspar were sold in 1999.


Closing the FDA's Orange Book 🔗

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