Apotex Hits Timing Snag Over 180-Day Exclusivity for Competitive Generic Therapy

October 25, 2018

The FDA denied a request by Canadian drugmaker Apotex to rescind its approval of a competing ANDA for a potassium chloride oral solution submitted by Novel Laboratories — granted on the same day Apotex qualified for 180-day competitive generic therapy (CGT) exclusivity.

In a test case for the CGT exclusivity status introduced by the 2017 FDA Reauthorization Act, the agency granted Apotex the first CGT exclusivity for its potassium chloride oral solution 10 percent and 20 percent and approved the company’s ANDA on Aug. 8.

However, the agency pointed out in its denial letter that the 180-day exclusivity period did not begin until Aug. 29, when the company actually notified the agency that it had begun commercial marketing. Hours earlier on the same day, the agency granted Novel’s ANDA for its versions of the same products.

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