Mylan Laboratories has announced that the U.S. Food and Drug Administration (FDA) has confirmed Mylan’s current status as the only approved ANDA for all strengths of Amlodipine Besylate Tablets.

The decision came to light in a filing on Wednesday with the U.S. District Court for the District of Columbia, which had enjoined the FDA from approving any additional Abbreviated New Drug Applications for amlodipine besylate tablets, 2.5 mg, 5 mg and 10 mg , for a period starting from April 11, 2007 through to at least April 13, 2007. The FDA informed the court that it would be soliciting views of interested parties on this matter by April 4, and that it would render an agency decision on April 11, 2007.

Mylan launched its generic version of Norvasc last month saying it is entitled to 180 days as the sole generic Norvasc seller and has been seeking a temporary restraining order to bar other generic Norvasc approvals during that time. Mylan appealed to the District of Columbia to stop the FDA from immediately approving other applications for amlodipine besylate products. The court ordered FDA to announce its final decision on further Norvasc generic approvals.

The FDA notified Mylan and all amlodipine besylate ANDA applicants that all of the unapproved amlodipine besylate ANDAs are currently blocked from approval by pediatric exclusivity and if the mandate from the March 21 appellate court decision related to the validity of the amlodipine besylate patent does not issue before September 25, 2007, “Pfizer and Mylan will have no additional competition during the interim period and thus will obtain the full benefit that could be derived under pediatric and 180-day marketing exclusivity.”

The FDA stated that in the event an appellate court order is issued prior to September 25, the only ANDA eligible for approval during that period will be from Apotex because of the favorable court decision in the Pfizer case. Mylan will continue to assert that even Apotex should either be blocked by Mylan’s 180-day exclusivity or not be approved during the pediatric exclusivity period based on multiple prior FDA rulings.

Amlodipine besylate tablets are the generic version of Pfizer’s Norvasc tablets, which had U.S. sales of approximately $2.7 billion for the 12-month period ending Dec. 31, 2006, according to IMS Health.

Earlier, in Pfizer v. Mylan Labs (02cv1628), a patent infringement action was brought by Pfizer under U.S. Pat. Nos. 4,572,909 and 4,879,303, which cover an amlodipine besylate product sold under the trade name Norvasc®.

Mylan filed an Abbreviated New Drug Application (“ANDA”) for approval to sell generic amlodipine besylate. Mylan certified pursuant to 21 C.F.R. 314.94(a)(12)(i)(A)(4) (paragraph IV certification) that it was seeking approval to market its generic copy of Norvasc® prior to the expiration of the ’909 and ’303 patents. The application stated that to the best of Mylan’s knowledge neither the ’909 nor the ’303 patents would be infringed by the manufacture, use or sale of the proposed generic amlodipine besylate.

Pfizer sued Mylan for infringement of both patents and sought “[a]n order preliminarily enjoining and permanently enjoining [Mylan] from making, using, selling, offering to sell, or importing into the United States the Mylan Amlodipine Tablets described in ANDA No. 76-418 until after the expiration of the ‘909 patent term, . . ., and after the expiration of the ‘303 patent term . . .”

Mylan argued that Pfizer’s claims for inducing infringement and infringement of the ‘909 patent should be dismissed for lack of subject matter jurisdiction. According to Mylan, since the ‘909 patent expired on July 31, 2006, there is no longer a case or controversy with respect to the ‘909 patent. Pfizer responded that the district court retains jurisdiction over a patent infringement case when the patent has expired but the period of pediatric exclusivity remains at issue. Because the ‘909 patent expired on July 31, 2006, the court found that the rights secured by the patent are no longer protectable and entitlement to injunctive relief becomes moot because such relief is no longer available.

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One Comment

  1. In a sense, it gives the exclusivty to Mylan, who possibly deserved it.

    So, till the time the Court Mandate arrives, Mylan and Pfizer + Pfizer’s authorsied generic will rule the market.