Generic exenatide from Amneal is listed for US marketing

A generic version of the GLP-1 injection exenatide is now listed for marketing in the United States. Amneal Pharmaceuticals LLC is the labeler on an FDA drug listing for exenatide injection with a marketing start date of Nov. 22, 2024, approved under ANDA 206697 ^[1]. The FDA said in December 2024 that it had approved the first generic referencing Byetta (exenatide) the month before ^[2].

The listing in FDA's National Drug Code directory describes a subcutaneous injection at a strength of 250 micrograms per milliliter, supplied in a 1.2 milliliter cartridge, one cartridge per carton ^[1]. The directory classifies the product as a GLP-1 receptor agonist and lists Amneal as the original packager ^[1]. The entry also carries a marketing end date of June 30, 2027, a date the listing does not explain ^[1].

The FDA's public statement about the exenatide generic came inside a Dec. 23, 2024 press release about a different product: the first generic version of liraglutide injection (Victoza), 18 milligrams/3 milliliters, granted to Hikma Pharmaceuticals USA Inc. ^[2]. In that release, the agency said it had "approved the first generic in this class of medications last month with the approval of a generic referencing Byetta (exenatide)" ^[2]. The FDA said it prioritizes review of generic applications for drugs in shortage, and noted that liraglutide injection was in shortage at the time ^[2]. The release does not say whether exenatide was in shortage.

"Generic drugs provide additional treatment options which are generally more affordable for patients," said Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research ^[2].

The FDA also said that generics of complex products such as GLP-1s can be harder to develop because of their active ingredient, formulation or mode of delivery, and that it runs programs meant to make such applications more feasible ^[2].

Several basic details are not yet known. The price of the generic exenatide, whether insurers will cover it, and how widely pharmacies will stock it have not been disclosed. Neither the FDA release nor the drug listing cited here mentions a generic version of the once-weekly extended-release form of exenatide ^[1][2]. The listing also does not state which patients the product is indicated for; that information is not included in the directory record ^[1].

Why it matters for patients

This is the first generic version of a GLP-1 medicine to reach the US market, following the FDA's November 2024 approval of a generic referencing Byetta ^[2]. In general, generic competition is one route to lower prices, and the FDA describes generics as generally more affordable for patients ^[2]. Whether that translates into a lower cost for any individual depends on the manufacturer's price, insurance coverage and formulary decisions, none of which has been reported.

Exenatide is not semaglutide or tirzepatide. A generic exenatide does not change the supply, price or insurance coverage of Ozempic, Wegovy, Rybelsus, Mounjaro or Zepbound, and the FDA release says nothing about those products.

For people who use the once-weekly extended-release form of exenatide, no generic version has been announced in either the FDA release or the drug listing ^[1][2]. The FDA release also does not address whether the newest generic will be substituted for existing prescriptions; substitution rules are set by state law and by the prescriber, not by this listing.

Because the FDA release covers exenatide only as a passing reference inside a liraglutide announcement, details such as side effects, warnings and approved uses for the generic exenatide are not described there ^[2]. The safety information the FDA did publish in that release applies to liraglutide, which carries a Boxed Warning about thyroid C-cell tumors and warnings about pancreatitis, low blood sugar when used with insulin or sulfonylureas, kidney problems, allergic reactions and gallbladder disease ^[2].

What happens next

The FDA said patients and clinicians should contact the manufacturer for information about availability of the generic liraglutide it approved in December ^[2]; the agency gave no launch timing for either product. Amneal has not stated in the records cited here when or where the generic exenatide will be stocked, or at what price. The exenatide listing carries a marketing end date of June 30, 2027 ^[1], which may affect how long the record stays active, though the listing does not explain the date.