The newly posted and updated Paragraph IV list, which provides the date that the first ANDA with a patent challenge was received by the FDA, has four very interesting listings, all of which make it clear that generic firms are not letting the moss grow under their feet.
The new listing, reproduced below, shows three drugs, Abiraterone Acetate Tablets, Linagliptin Tablets, and Lingagliptin and Metformin HCL Tablets that were submitted on the first day they were eligible to be submitted. In this case, since all three innovator products were subject to a period of new chemical entity (NCE) exclusivity, that date was four years from approval of the entity subject to the NCE exclusivity. All three obviously had paragraph IV certifications and thus the date of submission in the chart below represents the first-to-receive date.
|Drug Name||Dosage Form||Strength||RLD||Date of Submission|
|Abiraterone Acetate||Tablets||250 mg||Zytiga||4/28/2015|
|Linagliptin and Metformin Hydrochloride||Tablets||2.5 mg/500 mg, 2.5 mg/850 mg, 2.5 mg/1000 mg||Jentadueto||5/4/2015|
|Posaconazole||Delayed-release Tablets||100 mg||Noxafil||6/16/2014|
The fourth drug on the list, Posaconazole, was received by the FDA just 7 months after approval of the innovator product. The delayed-release version of this antifungal was a new dosage form of the original suspension form of the drug originally approved in 2006; thus, the NCE exclusivity has expired well before the time of submission of the ANDA. A 7 month time for development and submission of an ANDA is about as fast as one can anticipate given the new stability requirements,
These four listings demonstrate that generic firms are trying to keep ahead of the curve to be in the market at the first available opportunity. It also demonstrates that generic companies are well equipped to be nimble in developing, testing, and submitting their ANDAs. This is another indication of the power of the Hatch-Waxman Act and its ability to spur generic competition. If the Office of Generic Drugs review and approval machine can keep up with the generic companies, these products will get to market at the earliest date possible.