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Braeburn Inc. v. United States FDA

United States District Court for the District of Columbia

July 22, 2019, Decided; July 22, 2019, Filed

Civil Action No. 19-982 (BAH)

Opinion

 [*5]  MEMORANDUM OPINION

Both the plaintiff, Braeburn Inc., and the intervenor-defendant, Indivior Inc., are pharmaceutical companies that manufacture drug products using buprenorphine, a safer alternative to methadone, to treat moderate-to-severe opioid use disorder ("OUD"). All parties recognize the serious national public health problem [**2]  posed by OUD and the need for effective treatment options for patients with this addiction. Braeburn's product, Brixadi, delivers buprenorphine through an injectable depot that releases buprenorphine over either a weekly or monthly period. In July 2017, Braeburn applied to the Food & Drug Administration ("FDA") for approval of Brixadi and, on December 21, 2018, received tentative approval for both Brixadi Weekly and Monthly. The critical hitch prompting this lawsuit is that, while Brixadi Weekly could receive final approval once Braeburn submitted proposed labeling to the FDA, Brixadi Monthly was not eligible for final approval until November 30, 2020, upon expiration of a three-year right to exclusivity, under 21 U.S.C. § 355(c)(3)(E)(iii), belonging to Indivior's buprenorphine drug product, Sublocade, which also is an injectable depot that releases buprenorphine over a one-month period.

Braeburn instituted this action on April 9, 2019 against the FDA and the Department of Health and Human Services, as well as the heads of those agencies in their official capacities, challenging the FDA's  [*6]  determination that Brixadi Monthly cannot be finally approved until Sublocade's three-year exclusivity expires. See generally [**3] , Compl., ECF No. 1. Shortly after, Indivior intervened as a defendant. Mot. Intervene, ECF No. 13; see also 1st Min. Order (Apr. 12, 2019) (granting Indivior's motion to intervene).

Now pending before the Court are cross-motions for summary judgment filed by Braeburn, ECF No. 24, Indivior, ECF No. 26, and the FDA, ECF No. 28. For the reasons explained below, Braeburn's motion is granted and both Indivior's motion and the FDA's motion are denied.1

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389 F. Supp. 3d 1 *; 2019 U.S. Dist. LEXIS 121423 **; 2019 WL 3290790

BRAEBURN INC., Plaintiff, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants, and INDIVIOR INC., Intervenor-Defendant

CORE TERMS

sealed, Monthly, patients, buprenorphine, innovation, clinical, conditions of approval, dose, drug product, depot, investigations, sponsor, Weekly, Reply, designation, opioid, effective, final approval, Cross-Motion, injection, regulations, label, stable, drugs, summary judgment, new drug, transmucosal, conditions, moderate, orphan