Apotex will have to wait at least a month before receiving renewed approval from the FDA to market generic Prilosec, a district court recently ruled. The company has marketed the product for three years.
The company sued the FDA in the U.S. District Court for the District of Columbia requesting an injunction against the FDA’s withdrawal of final approval for its generic Prilosec (omeprazole) abbreviated new drug application (ANDA), according to court records.
The FDA converted the final approval, which it granted in October 2003, into a tentative approval in June after AstraZeneca prevailed in patent litigation, Judge Ricardo Urbina wrote in his Sept. 17 opinion.
The U.S. District Court for the Southern District of New York had ruled that Apotex’s product infringed on AstraZeneca’s Prilosec patents and that no generic product shall be approved or marketed until the pediatric-exclusivity period for the patents expires Oct. 20, Urbina wrote.
As a result of that decision, the FDA revoked final approval of Apotex’s product until at least Oct. 20, which Apotex said violated the Administrative Procedure Act. In addition to asking the court to reinstate final approval for its generic Prilosec, Apotex asked the court to grant it interim relief pending appeal, according to the opinion.
But Apotex failed to show that it is likely to succeed on the merits or that it will suffer irreparable injury, so the court denied the company’s motions for injunctive relief and stay pending appeal, Urbina wrote.
The company sued the FDA in the U.S. District Court for the District of Columbia requesting an injunction against the FDA’s withdrawal of final approval for its generic Prilosec (omeprazole) abbreviated new drug application (ANDA), according to court records.
The FDA converted the final approval, which it granted in October 2003, into a tentative approval in June after AstraZeneca prevailed in patent litigation, Judge Ricardo Urbina wrote in his Sept. 17 opinion.
The U.S. District Court for the Southern District of New York had ruled that Apotex’s product infringed on AstraZeneca’s Prilosec patents and that no generic product shall be approved or marketed until the pediatric-exclusivity period for the patents expires Oct. 20, Urbina wrote.
As a result of that decision, the FDA revoked final approval of Apotex’s product until at least Oct. 20, which Apotex said violated the Administrative Procedure Act. In addition to asking the court to reinstate final approval for its generic Prilosec, Apotex asked the court to grant it interim relief pending appeal, according to the opinion.
But Apotex failed to show that it is likely to succeed on the merits or that it will suffer irreparable injury, so the court denied the company’s motions for injunctive relief and stay pending appeal, Urbina wrote.