CGT Exclusivity: How the Timing of Commercialization Caused Apotex to Lose its 180 Days

Regulatory NewsRegulatory News | 15 October 2018 |  By 

When Apotex won approval and competitive generic therapy (CGT) exclusivity for its abbreviated new drug application (ANDA) for potassium chloride 10% and 20%, the company thought it would enjoy the 180 days’ worth of exclusivity that comes with the designation, though FDA explains in a letter released Friday why that was not the case.

From Apotex’s perspective, the CGT exclusivity should have blocked FDA from approving another ANDA from Novel Laboratories for the same product.

But the problem is that the exclusivity begins from the time of the first commercial marketing of the CGT, and Apotex notified FDA that it had commenced commercial marketing a little more than five hours after FDA had already approved Novel’s ANDA.

“The Food Drug & Cosmetic Act provision governing the manner in which a ‘first approved applicant’s’ CGT exclusivity blocks approval of subsequent ANDAs for the same drug product is unambiguous,” FDA told Apotex. “It states that, subject to other requirements for approval, ‘if the application is for a drug that is the same as a competitive generic therapy for which any first approved applicant has commenced commercial marketing, the application shall be made effective on the date that is 180 days after the date of the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant.’”

And in Apotex’s arguing that a first approved applicant’s CGT exclusivity “prevents FDA from approving a subsequent ANDA from the time of the first applicant’s approval, Apotex reads the ‘commenced commercial marketing’ language out of the statute entirely,” FDA said.

“Despite Apotex’s commencement of commercial marketing for potassium chloride 10% later that same day, the threshold condition in the statute (i.e., that ‘any first approved applicant has commenced commercial marketing’) had not been met when FDA approved Novel’s ANDA,” the agency added.

Apotex also argued that CGT exclusivity should operate like 180-day exclusivity predicated on a first applicant’s paragraph IV (PIV) patent certification.

But FDA said: “Apotex’s comparison of 180-day CGT and PIV exclusivity illustrates the flaw in Apotex’s reasoning.”



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Tags: exlcusivity

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