Apotex Launches First Generic Plavix®
Consumers Have Immediate Access to an Affordable Version of this Important Product
Weston, Florida, August 8, 2006 -- Apotex Corp. announced that it has
today launched clopidogrel bisulfate 75 mg tablets. Clopidogrel is the generic
equivalent
of Sanofi's Plavix®, which is marketed in the U.S. by Bristol Myers Squibb.
As the first generic company to file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) for clopidogrel, Apotex will have 180 days of market exclusivity for the product. Sales for clopidogrel 75 mg tablets in the U.S. for the twelve month period ending June 2006 are approximately $3.77 billion according to IMS Health.
On July 28, the States' Attorneys General reviewing the modified settlement submitted in June by Apotex, BMS, and Sanofi to the Federal Trade Commission (FTC) and the states rejected the agreement. The proposed settlement, which was first announced in March, halted the trial over the infringement case filed by Sanofi/BMS against Apotex over U.S Patent No. 4,847,265 (the '265 patent) that had been scheduled for June.
Apotex Chief Executive Officer Dr. Barry Sherman said: "Apotex believes its clopidogrel launch to be the largest and most successful launch in the history of the generic industry. We are confident that the patent will be held invalid and that the courts will find inequitable conduct before the Patent Office on the part of Sanofi. Accordingly, Apotex has launched prior to trial so that patients and public and private health care payors can begin benefiting from a quality, low-cost alternative to Plavix® immediately rather than years from now."
"There should be no mistaking," Sherman added "that our decision to launch a generic version of this blockbuster product at risk is a testament to our commitment to patients, consumers, and taxpayers."
The U.S. Food and Drug Administration approved Apotex's ANDA for clopidogrel in January following the expiration of the automatic 30 month stay of approval imposed by federal law when a brand company files an infringement suit against a generic manufacturer challenging its patents. At the time of the ANDA's approval, Apotex was in the midst of patent litigation with Sanofi-Aventis concerning clopidogrel in the U.S. District Court of the Southern District of New York, over the validity and enforceability the '265 patent.
In March, Apotex, Sanofi and BMS announced a proposed settlement of the litigation.
After reviewing the proposed settlement, the States' Attorneys General advised that they would not approve the agreement in its then current form. In June, Apotex, BMS, and Sanofi announced a modified agreement had been submitted to the FTC and the states for review. Both agreements would
have resolved the litigation and would have granted Apotex a license to market the generic product several months in advance of the expiration of the patent in return for settling the suit. On July 28 the States' Attorneys General announced their rejection of the modified agreement. The latter agreement contained provisions assuring a smooth launch by Apotex in the event approval of the agreement's settlement terms was not obtained. Under the agreement, Sanofi and BMS have agreed not to seek a temporary restraining order in the event Apotex launched sales of the generic product and not to seek a preliminary injunction until at least five business days after Apotex began shipments. In the event Sanofi and BMS ultimately seek a preliminary injunction, Apotex believes it has strong defenses to such an effort.
As a result, Apotex has decided to immediately launch clopidogrel.
Apotex' clopidogrel tablets are packaged in bottles of 30s, 90s, 1000s, and 100 count unit dose blisters.
The Apotex Group manufactures more than 200 different high-quality generic pharmaceuticals, used by millions of patients worldwide. Its product line includes oral solids, liquids, injectables, nasal sprays, opthalmics, and inhalation solutions.
Plavix® is a registered trademark of Sanofi-Aventis.
Apotex Corp. is the US Subsidiary of Apotex, Inc., the largest Canadian-owned manufacturer of prescription drugs. Through its sales and marketing headquarters in Weston, Florida and operations center in Indianapolis, Apotex Corp, is committed to providing safe and affordable generic medicines. Products manufactured and marketed by the Apotex Group are sold in 115 countries around the world. For more information visit apotexcorp.com.
Source: Apotex Corp. |
