Drugs

Reject Lannett 505(b)(2) Cocaine Submissions: Genus

David McFarland

— 1 min read
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Genus Lifesciences has petitioned FDA to refuse to accept any submissions by Lannett Company for its 505(b)(2) application for cocaine hydrochloride 4% and 10%. A Genus 2/1 petition says the Lannett submissions are barred by the new chemical entity (NCE) exclusivity arising from FDA approval of the Genus NDA for cocaine hydrochloride nasal solution 4% on 12/14/17.

The petition says that according to the Food, Drug, and Cosmetic Act, no application may be submitted on the same active ingredient before the expiration of five years from the date of the approval of the application. Genus’ NDA new chemical entity exclusivity does not expire until 12/14/2022, the company says, and thus no 505(b)(2) or ANDA may be submitted before 12/14/2022.

Specifically, Genus asks that FDA: 

  •          refuse to accept any further submissions of Lannett’s 505(b)(2) application for any cocaine product, including any amendment, supplements, or resubmissions;
  •          treat as withdrawn any submissions FDA may have accepted from Lannett in support of its 505(b)(2) application after 12/14/2017; and
  •          consider Lannett’s 505(b)(2) application for a cocaine product withdrawn.

“Congress created the five-year NCE exclusivity to protect the pharmaceutical industry’s investment in the development of new chemical entities,” the petition concludes. “Congress could have carved out an exception for dueling 505(b)(2) applications submitted before either application obtained NCE exclusivity. But Congress did not. FDA should have deemed withdrawn any co-pending 505(b)(2) application for cocaine once Genus obtained NCE exclusivity. At the very least, FDA should refuse to accept any submissions in furtherance of Lannett’s 505(b)(2) application for cocaine after 12/14/17 (the approval date for the first cocaine product) until 12/14/2022 (expiration of exclusivity). Moreover, FDA must withdraw Lannett’s 505(b)(2) application now that Lannett has received a complete response letter because Lannett should not be permitted to resubmit its application in response to a complete response letter.”

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