Generic Celebrex Dispute Shows Hatch-Waxman’s Legal Wrath
Ongoing battle over 180-day exclusivity shows just how complex life under the 1984 amendments to the FD&C Act can get.
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Pfizer sues five generic firms alleging their celecoxib ANDAs infringe a reissued method-of-use patent, which protects the blockbuster COX-2 inhibitor until December 2015, 18 months longer than had been expected.
Unless reauthorized by Congress, the rare pediatric disease program will begin to expire in September; renewal could bring bigger changes across the three PRV programs, including an FDA-requested clarification of biologic products eligible for vouchers and reforms suggested by sponsors and other stakeholders in a recent GAO report.
The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.