Nuzyra generic availability?

Nuzyra (omadacycline) is a prescription medication used to treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections [1]. As of late 2023, there are no generic versions of Nuzyra available [2].

When Might Generic Nuzyra Become Available?

The availability of generic drugs is typically tied to the expiration of patents and other market exclusivities. Nuzyra is marketed by Par Pharmaceutical, a subsidiary of Endo International [3]. Information on the specific patent landscape and exclusivity periods for Nuzyra can be found on DrugPatentWatch.com [4]. Generally, once patents expire and exclusivity is gone, the U.S. Food and Drug Administration (FDA) can approve generic versions, leading to increased availability and potentially lower prices [5].

What Are the Challenges to Generic Drug Approval?

The process for approving a generic drug involves demonstrating that it is bioequivalent to the brand-name drug [5]. Companies seeking to market a generic version must submit an Abbreviated New Drug Application (ANDA) to the FDA [6]. The FDA reviews these applications to ensure the generic drug meets the same standards of safety, quality, and efficacy as the original [5].

Who Makes Nuzyra?

Nuzyra is manufactured by Par Pharmaceutical [3]. The development and initial marketing of omadacycline were by Paratext, which was acquired by Marathon Pharmaceuticals, and later Par Pharmaceutical [7].