On Tuesday, April 7th, the FDA announced that the Office of Generic Drugs had approved multiple first generics for Dapagloflozin Tablets. A quick review of the listings for the product in the Orange Book shows that there were a total of fifteen ANDAs approved on Monday, April 6th, which was the first business day that the FDA could have approved these ANDAs after expiration of the Pediatric Exclusivity period associated with U.S. Patent No. 6,515,117 on Saturday, April 4th. The FDA’s Paragraph IV Patent Certifications list indicates that there were a total of twenty ANDAs submitted on the NCE-1 date of January 8, 2018. Approving fifteen ANDAs from a cohort of twenty applications is commendable for both the FDA and the applicants. A review of the Tentative Approvals by Month on drugs@fda establishes that several ANDA sponsors were granted Tentative Approval prior to the 30-month date by which First Applicants need to secure Tentative Approval or risk possible forfeiture under the Failure to Obtain Tentative Approval forfeiture provision at 505(j)(5)(D)(IV) of the FD&C Act. Under the FDA’s “Nateglinide Precedent” (Nateglinide 180-Day Determination) those First Applicants that did secure Tentative Approval within 30-months have effectively secured the 180-day exclusivity period for all First Applicants.
Of course, with a total of fifteen approved ANDAs now, it will be interesting to see how many of these applicants will actually commence marketing of their ANDA products. An announcement in Drug Store News indicates that one party has launched, and I have knowledge that at least one other party has launched as well. I’m assuming that we’ll see updates to the Orange Book with inclusion of the Patent Challenge (PC) code indicating the expiration of the 180-day exclusivity period to corresponding ANDAs and FDA’s Paragraph IV Patent Certification list in the coming days to weeks. Thus, it appears that there will be a robust market with multiple participants, resulting in price reductions anticipated by the Hatch-Waxman Act, a win for patient access.
Notably, Farxiga was on the list of ten drugs that were originally selected for price negotiations under the Inflation Reduction Act for which negotiated prices went into effect on January 1, 2026. A document authored by CMS (Medcare Drug Price Negotiation Program: Negotiated Prices for Initial Price Applicability Year 2026) includes a table showing that a 30-day supply of Farxiga in 2023 cost $556, but as of January 1, 2026 the cost had been reduced to $178.50, which already represented a 68% price reduction. The ANDA sponsors that are launching will now, presumably, be competing on price reductions from $178.50 rather than the previous price charged for Farxiga. This, of course, represents yet another challenge for generic manufacturers facing constantly eroding prices for their products.
