The Office of Generic Drugs (OGD) posted its latest paragraph IV listings and, while there was only one new addition to the list, that product caught my attention. The new listing was for Naltrexone Hydrochloride and Bupropion Hydrochloride Extended-Release Tablets 8mg/90mg. It is the generic for Contravene, which is a diet medication for the obese and significantly overweight.
Well, we know that, eventually, all new drugs may face generic competition, but this may be close to a record for extended-release tablets, as the generic application referenced in the paragraph IV database was filed on March 12. 2015. This date is notable for two reasons. First, it demonstrates that OGD is really expediting the filing of paragraph IV ANDAs as this filing acceptance review occurred within 31 days of submission of the ANDA. Secondly, the NDA upon which this ANDA is based was approved on September 10, 2014. That is 6 months from approval of the NDA to submission of the ANDA. That is a remarkable turnaround, especially for a complex extended-release dosage formulation.
With a series of 7 patents listed that extend from June 2024 to February 2030, and 3-year Hatch-Waxman exclusivity that expires September 10, 2017, we don’t expect to see approval of an ANDA for this product anytime soon, but this illustrates the push that firms will go to in order to gain first-to-file position. In the old days (during my time at FDA), we never saw this much of a race for first-to-file status. This may be in part because of the Mova decision. Remember that FDA’s initial interpretation of the Hatch-Waxman Act relative to qualifying for 180-day exclusivity was that, you not only had to be first-to-file, but you also had to win your patent challenge. That position was overturned by the so-called Mova decision. In that case, the courts ruled all you have to do is be one of the first-to file; however, not only don’t you have to win your patent challenge to quality for 180-day exclusivity, you don’t even need to be sued! (There are obviously some other considerations relative to 180-day exclusivity but we won’t get into those for today’s discussion).
It appears that generic manufacturers are pulling the trigger on new NDA products earlier and earlier. Keep your eye on this one, as the legal issues and any FDA 30-month stay will certainly be interesting in the race to market.
