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Slayback Exclusivity On Taytulla Does Not Bar Rival ANDA Product

US-Based Player Received Approval With CGT Designation

 
• By Dean Rudge

Slayback Pharma has now launched its Merzee generic version of Allergan’s Taytulla oral contraceptive with a CGT designation, several months after Xiromed moved first.

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“CGT exclusivity is not applied retrospectively," Slayback told Generics Bulletin • Source: Shutterstock

No additional generic versions of Allergan’s Taytulla (norethindrone acetate/ethinyl capsules; ferrous fumarate capsules) will be approved before late July, after Slayback Pharma launched its AB-rated generic, Merzee, with an ‘effective’ 180-day market exclusivity period provided under the competitive generic therapy pathway.

Slayback clarified that its launch of the oral contraceptive will not impact the first generic version of Taytulla, Xiromed’s Gemmily, which launched in November last year. (Also see "Insud’s Xiromed Rivals Taytulla In US" - Generics Bulletin, 23 November, 2020

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