A Tale of Competing Cocaine Drugs: Genus Sues FDA Over its NCE Exclusivity

Regulatory NewsRegulatory News | 29 January 2020 |  By 

Genus Lifesciences this week sued the US Food and Drug Administration (FDA) because the company believes the agency acted unlawfully in allowing a competitor to bring its cocaine hydrochloride product to market.

The case hinges on FDA’s decision to grant new chemical entity (NCE) exclusivity to Allentown, PA-based Genus following the December 2017 approval of Goprelto (cocaine hydrochloride), which is indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.

NCE exclusivity is granted to a drug that contains an active moiety that has not been previously approved by FDA. The exclusivity means FDA is barred from accepting for review any abbreviated new drug application (ANDA) or 505(b)(2) application for a drug containing the same active moiety for five years if a competitor does not contain a paragraph IV certification to a listed patent, or four years if it does contain a paragraph IV certification to a listed patent.

In this case, Goprelto’s NCE exclusivity extends until 14 December 2022.

However, just a month prior to Goprelto’s approval, FDA officially accepted a competing cocaine hydrochloride 505(b)(2) application for review, and after issuing an initial complete response letter (CRL) to the applicant Lannett in July 2018, accepted a resubmitted application and then approved Lannett’s Numbrino (cocaine hydrochloride) earlier this month.

Genus takes issue with FDA’s decision to accept this competitor’s application for review, especially as FDA “would not accept its application until a battery of time-consuming and expensive studies were performed.” But with Lannett’s application, which should have been barred from even undergoing review because of the exclusivity, the agency “applied more lenient acceptance criteria,” Genus contends.

At the crux of Genus’s argument is that FDA unlawfully accepted both the initial Lannett submission and the resubmission even though the additional work required by FDA’s CRL “was so extensive” that Lannett did not resubmit its application until nearly a year after the CRL.

The company also explains how FDA’s issuance of the CRL to Lannett, and the extended time between resubmission and approval “leaves no doubt that Lannett’s application as submitted was significantly less complete than Genus’s at the outset, and should not have been accepted by FDA if the agency were applying a uniform, nonarbitrary standard for acceptance of new drug application submissions.”

Genus also takes issue with the fact that FDA allowed Lannett to “attempt to plug the many holes in its initial submission by amending and even resubmitting its application,” while Genus’s NCE exclusivity was in effect.

Robert Jaffe, spokesperson for Lannett, told Focus via email: "The lawsuit raises arguments which the FDA correctly denied in two successive Citizen Petitions filed by Genus. We believe the plain language of the statute is clear and the FDA properly approved the 505(b)(2) application for Numbrino."

FDA’s Opinion

For its part, FDA explained its thinking in one of its petition response letters after Genus sought to block the review of the Lannett application back in July.

FDA explained how it received Lannett’s 505(b)(2) application on 21 September 2017 and that the application was “sufficiently complete to permit a substantive review” and considered the application filed 60 days after it was received, which may be why Genus believes the application was filed in November 2017.

The agency also explains how at that time, it could have a issued a refuse-to-file (RTF) decision, which means that the application is not complete enough for an FDA review and an approval decision.

But FDA notes how Genus’s petition “conflates fileability issues and review issues,” when it says that FDA applied “a more lenient filing standard to Lannett's application.” And the agency says that Genus wrongfully asserts that Lannett's submission in response to the CRL constitutes a "reapplication" submitted after FDA approved Goprelto. But the agency notes that a submission in response to a CRL “is considered an amendment after a CR action to a pending, unapproved application, not a new application.”

The agency further takes issue with several of Genus’s assertions, some of which it says “are contradicted by the written pre-NDA meeting communications between FDA and Genus.”

“FDA also provided pre-NDA preliminary meeting comments to Lannett for Numbrino using the same substantive standard language as provided to Genus for Goprelto about the need to include all pertinent clinical pharmacology information in its NDA and provided Lannett the same options for obtaining this information,” the letter adds.


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