The first ANDA for Vivus’s diet drug Qsymia (phentermine hydrochloride and topiramate) appeared in today’s Paragraph IV new postings. The Paragraph IV database is where first-to-file ANDAs containing Paragraph IV challenges to the reference listed drug are posted. The receipt date reported on the FDA site is July 18, 2013, which is just 6 days more than a year since Qsymia was approved (July 12, 2013).
Qsymia is an extended-release product; thus, the turnaround for generic development, generation of required stability data, conduct of successful bioequivalence studies and putting the ANDA together was almost as much time as FDA took to decide the ANDA was acceptable for receipt (almost 10 months).
This brings out two important points for all interested in the generic industry to recognize:
- Interest in getting an ANDA approved for a potential blockbuster drug has not waned in the generic industry and firms will pull out all stops to be first to file.
- It is taking longer to obtain filing acceptance for ANDAs, especially for extended-release products.
So the race to be first to file is still on, but, for a complex dosage form, to submit an ANDA 12 months from the date of approval of the original ANDA is a stunning feat. For new chemical entities subject to 5 years of market protection before an ANDA can be submitted (4 if there is a patent and the ANDA applicant challenges the patent), we fully expect first-to-file applications to be submitted on the NCE-1 date, but in that case, ANDA applicants have 4-5 years to develop the product. In the case of Qysymia, which combines two previously approved moieties, there is no barrier to ANDA submission.
So the patent fight is on and let’s watch this one to see how the battle goes. Given this ANDA was in GDUFA cohort year 1, there are no goal dates, so let’s see how the Office of Generic Drugs does with this one!