Faulding Challenges New FDA Rule
Purepac Pharmaceutical Co, a subsidiary of F H Faulding & Co, is challenging the legality of the Food and Drug Administration's new policy governing the award of 180-day generic drug exclusivity. To this end, it has issued a lawsuit in the U.S. District Court for the District of Columbia.
Richard Moldin, CEO of Faulding Oral Pharmaceuticals, reports that despite receiving approvable status for its Abbreviated New Drug Application (ANDA) for ticlopidine hydrochloride tablets (the generic version of Ticlid brand tablets) the FDA has not given us permission to market the product.
The FDA has informed Purepac that the only block to Purepac's receipt of final marketing clearance is the FDA's recent determination that the first company to file an ANDA with respect to ticlopidine hydrochloride is entitled to a 180-day head start in the market commonly known as "market exclusivity"—despite the fact that the first ANDA applicant was not sued for patent infringement by the brand company.
Purepac's ANDA for ticlopidine hydrochloride appears to be the first that has been blocked by the FDA's new Guidance for Industry that was issued on June 22, 1998. The Guidance announced the agency's new position on generic exclusivity and approvals in light of recent judicial rulings which had invalidated one element of the FDA regulation governing the field. Once exclusivity has been awarded, the only events that will trigger the commencement of the 180-day exclusivity period are the earlier of (1) a final court decision of non-infringement or invalidity of the brand company's patent in a lawsuit, or (2) the commercial launch of the product in question by the first ANDA applicant.
Purepac has filed a complaint and an application for a temporary restraining order to reverse FDA's actions.
Moldin contends that because of this FDA decision, the American public is being denied a chance to buy more affordable pharmaceuticals.
Ticlopidine hydrochloride is a blood thinner indicated to reduce the risk of fatal and non-fatal thrombotic strokes. Current drug store sales data indicate that US sales of Ticlid are approximately US$270 million per year. Roche Laboratories, Inc markets Ticlid.
Purepac Pharmaceutical Co develops, manufactures, and markets human generic pharmaceuticals.
For more information: Andrew Berdon, Faulding Oral Pharmaceuticals. Tel: 908-659-2411.