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Pharmaceuticals / Regulatory Affairs

FDA Parries on Teva 180-Day Exclusivity Suit

Nov. 20, 2018
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The FDA hit back at Teva’s lawsuit accusing the agency of changing its policy on granting 180-day exclusivity for generics — arguing that the company’s attempt to block exclusivity for competing Restasis (cyclosporine) generics was “built atop a tottering tower of conjecture.”

In its lawsuit filed in October, Teva said the agency had previously maintained that eligibility for 180-day exclusivity was based on a generic applicant’s submission of a legally valid challenge to the referenced drug patents.

In July, however, the agency issued a decision letter to Dr. Reddy’s and Mylan regarding their ANDAs for Suboxone generics, ruling that ANDA applicants are eligible for exclusivity whether or not they provide a certification challenging the validity of the reference drug’s patents. Teva argued this interpretation turned the “incentive structure upside down.”

The FDA responded that the drugmaker is “nowhere close” to meeting the requirements for a preliminary injunction, including proving the complaint’s likelihood of success.

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