FDA Says Hi-Tech Forfeited Exclusivity;
Way Paved for Approval of All Cosopt ANDAs
November 7, 2008Reproduced with permission from Pharmaceutical Law & Industry Report, Vol. 6, p. 1260. Copyright 2008 - The Bureau of National Affairs, Inc.
View Link
Hi-Tech Pharmacal Co. forfeited its 180-day period of exclusivity for a generic version of Merck & Co.’s eye disease treatment Cosopt (dorzolamide hydrochloride and timolol maleate), the Food and Drug Administration told the company in a letter released Oct. 29.
FDA gave final approval Oct. 28 to Hi-Tech’s abbreviated new drug application (ANDA) to make a generic version of Cosopt and to Apotex Inc.’s ANDA for generic Cosopt— the opposite of the result that Hi-Tech was seeking.
Meanwhile, Prasco Laboratories said Oct. 28 it had begun shipping an authorized generic version of Cosopt under an agreement with Merck. The brand-name drug had annual sales of $342 million for the 12 months ending June 2008.
Hi-Tech earlier sought a preliminary injunction banning FDA from approving any other generic copies of Cosopt during Hi-Tech’s exclusivity period under the Hatch-Waxman Act, but a federal court rejected its request Oct. 10 (6 PLIR 1202, 10/24/08).
Cosopt is a brand-name ophthalmic drug marketed by Merck to reduce elevated intraocular pressure (IOP) in certain patients with open-angle glaucoma or ocular hypertension. The agency said that Hi-Tech can be found to have failed to market the generic drug by a
certain deadline if a triggering forfeiture event occurs, which, in this case, is the brand-name company’s request to delist relevant patents from the FDA Orange Book.
Third MMA Forfeiture Exclusivity Decision. FDA’s latest exclusivity decision is its third decision to address the forfeiture provisions of the 180-day exclusivity period under the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA). It follows earlier exclusivity decisions on acarbose (FDA Docket No. 2007-N-0445, 5/7/08) and granisetron (FDA Docket No. 2007-N-0389, 1/17/08).
The latest decision ‘‘certainly cuts back on the availability of the 180-day exclusivity period,’’ Steven H. Sklar of Leydig, Voit & Mayer, Chicago, told BNA.
‘‘The key point,’’ Sklar said, ‘‘is [the] harshness of FDA’s interpretation involving the failure of an ANDA filer to get to market within 30 months of the date of submission of the ANDA. According to FDA, this 30-month deadline is not stayed or otherwise delayed if an ANDA filer can’t get to market due to another patent or exclusivity.’’
Sklar observed that it is not ‘‘uncommon’’ for an ANDA filer to file a Paragraph III certification on a molecule patent and a Paragraph IV on a later-expiring formulation or polymorph patent. Under a Paragraph III certification under the Hatch-Waxman Act, an applicant certifies that it will not seek to market the generic drug until the patent expires. With a Paragraph IV certification, an ANDA applicant seeks to market a generic before the patent at issue expires, certifying that the patent is invalid or not infringed. But Sklar said, ‘‘Based on FDA’s decision in this case over Cosopt, it would appear that there is no way to hold onto any 180-day exclusivity based on the Paragraph IV [certification] for the later-expiring patents.’’
To read the full article, click the PDF icon below.
View as PDF
