Apotex Sues FDA Over Gabapentin ANDAs, Says Purepac Generic Exclusivity For Neurontin Has Run
This article was originally published in The Pink Sheet Daily
Executive Summary
Under the “one first applicant” approach, Purepac’s exclusivity expired in April 2002, clearing the way for other ANDA approvals, Apotex asserts. The company’s argument is based on a federal judge’s ruling in a dispute over “shared exclusivity” for Paxil generics.
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Apotex is suing FDA for immediate approval of its ANDA for Pfizer's Neurontin and to stay approval of Purepac's generic version of the epilepsy agent. In a lawsuit filed April 14 in D.C. federal court, Apotex asserts the only 180-day exclusivity period attached to Purepac's ANDA for gabapentin has already run. Alpharma's Purepac division received final ANDA approval in September; the company was awarded 180-day generic marketing exclusivity as the first filer against Pfizer's drug composition patent (no. 6,054,482). Purepac has not yet launched because the company is in patent litigation with Pfizer. Final approval of Apotex' ANDA is blocked until Purepac's 180-day exclusivity runs. Apotex' lawsuit is predicated on a Jan. 2 ruling in a dispute over "shared exclusivity" for generic versions of GlaxoSmithKline's Paxil (paroxetine). In the paroxetine case, a D.C. federal judge ruled FDA should award exclusivity only to the first applicant to file an ANDA with a Paragraph IV certification against any patent covering an innovator's product. FDA is appealing the court's ruling. Applying this "one first applicant" approach to gabapentin, Apotex asserts Purepac's 180-day exclusivity attaches to its first Paragraph IV certification, which was filed against a patent covering the monohydrate form of the drug. However, that exclusivity was triggered in October 2001 in a separate court case and expired in April 2002, Apotex asserts. "The only exclusivity period for gabapentin capsules, if any, has long since expired, thus opening the gabapentin market to Apotex and any other approvable applicants," the lawsuit states. Apotex previously has argued that it is entitled to shared exclusivity for gabapentin. FDA awarded exclusivity to Purepac after Pfizer delisted the Neurontin patent (No. 4,084,479) against which Apotex was the first to file. The agency's award of marketing exclusivity to Purepac was affirmed by a D.C. appeals court Jan. 20. - Elizabeth Walker |