BARR's ANDA FOR GENERIC VERSION OF MAXZIDE was submitted before other me-too applications, entitling the firm to 180 days of exclusive marketing, the company maintained in a Nov. 13 complaint filed against EDA in New Jersey Federal Court. The complaint challenges FDA's decision to grant 180 days of ANDA exclusivity to another company, Vitarine. FDA awarded exclusivity to Vitarine, maintaining that the firm was the first to both file an ANDA and to contest successfully Mylan's patent for the triamterene/hydrochlorothiazide product. Barr's complaint argues that no generic versions of Maxzide should be entitled to exclusivity. If, however, the court believes that exclusivity is justified, then Barr claims that as the first ANDA submitter, it should be the company to receive the 180 days exclusive marketing. Barr "was the first ANDA applicant to submit an ANDA for the product including a certification [that the generic would not infringe Mylan's patent]," the complaint states. Therefore, "if any applicant is entitled to ANDA exclusivity then such exclusivity should be awarded to plaintiff." Barr's assertion that it was the first company to file an ANDA for the antihypertensive appears to rest on the interpretation that the date of ANDA filing is triggered by the initial submission without bioavailability studies. The complaint notes that Barr submitted its ANDA application, protocol for a bioavailability study, and certification statement claiming noninfringement of Mylan's patent on April 23, 1986, almost two months before Vitarine submitted the same information. Vitarine, however, submitted its bioavailability study on June 16, 1986, while Barr submitted its study on Sept. 4, 1986. FDA, in a Nov. 3 letter to American Therapeutics granting prospective approval to the firm's ANDA for the combination product, explained that it interprets the law as granting ANDA exclusivity to the first firm to file a complete ANDA application with bioavailability studies and patent certification ("The Pink Sheet" Nov. 9, p. 4). American Therapeutics is currently the only company with ANDA approval for a generic version of Maxzide. The company, which cannot come to market until April 17, 1988 because of Vitarine's exclusivity, also has filed a complaint against FDA alleging that the exclusivity grant was arbitrary and capricious (The Pink Sheet" Nov. 16, p. 13). Both Barr's and American Therapeutics' complaints maintain that the Maxzide patent is a process patent and therefore not covered by ANDA exclusivity provisions of the Waxman/Hatch Law. Barr's complaint also notes that the company expects to receive approval for its triamterene/hydrochlorothiazide ANDA in the near future. "Upon information and belief, in addition to the approval granted to American Therapeutics, approval of one or more of the ANDAs for the product, including Barr's application, is imminent," the filing states. Watson Labs, according to the complaint, also has an ANDA pending for the antihypertensive. FDA is currently under a temporary restraining order preventing further ANDA approvals for generics of Maxzide. New York Federal Eastern District Court issued the restraining order on Nov. 13 in response to American Therapeutics' complaint. A hearing is scheduled for Nov. 23.
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