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FDA added liraglutide injection to its drug shortage list on July 18, 2023

A shortage that began in July 2023 is still open on FDA's list, and it changed when a first generic version of liraglutide reached the market.

By the Semaglutides news desk·

Liraglutide injection was first posted to the FDA's drug shortage database on July 18, 2023, and the agency still lists it as currently in shortage [3]. The listing covers the once-daily GLP-1 injection sold as Victoza and Saxenda, along with generic copies of the medicine [3]. Liraglutide is a separate molecule from semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound), so it is a different supply line from those products [3].

What the FDA shortage page now shows

The FDA page for liraglutide injection lists it as "Currently in Shortage" under the therapeutic category Endocrinology/Metabolism, with a date first posted of 07/18/2023 [3]. The most recent company entries, revised in August and September 2026, show a mixed picture. Novo Nordisk's Saxenda, liraglutide 6 mg/1 mL, is listed as limited availability, with the product available until discontinuation in January 2027; the stated shortage reason is discontinuation of the manufacture of the drug [3]. Victoza in two package sizes is listed as limited availability with an estimated shortage duration of "TBD" and a stated reason of delay in shipping [3]. Generic liraglutide from Hikma Pharmaceuticals and Meitheal Pharmaceuticals is listed as available, as are two liraglutide packages distributed by Teva [3]. A separate FDA shortage record lists one Teva liraglutide package, NDC 0480-7250-46, as "To Be Discontinued," with a discontinued date of May 14, 2026 and the reason given as discontinuation of manufacture [1].

A generic arrives during the shortage

On December 23, 2024, the FDA approved the first generic referencing Victoza, liraglutide injection 18 milligram/3 milliliter, for improving blood sugar control in adults and children aged 10 years and older with type 2 diabetes, used alongside diet and exercise [2]. The agency granted the approval to Hikma Pharmaceuticals USA Inc. and said patients should contact the manufacturer about availability [2].

The FDA said in that announcement that liraglutide injection and certain other GLP-1 medications were in shortage at the time, and that the agency prioritizes assessment of generic drug applications for drugs in shortage to help improve patient access [2]. The FDA approved a generic referencing Byetta (exenatide) the month before, the first generic in this drug class [2].

"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 agency said liraglutide is harder to copy than a simple pill because of its active ingredient, formulation and delivery method, and that it uses guidance and a pre-ANDA program to clarify expectations for manufacturers [2].

Why it matters for patients

The shortage has lasted more than three years on FDA's list, and the brand-name versions are not fully available [3]. People who take Victoza or Saxenda may find that pharmacies cannot always fill a prescription on the usual schedule, and the FDA page shows a planned end for Saxenda in January 2027 [3].

A generic option exists. The FDA approved generic liraglutide in December 2024, and several generic packages are now listed as available on the shortage page [2][3]. Whether a specific pharmacy stocks a specific strength or package is not something the FDA page reports, and pricing is not disclosed in these records [2][3].

Safety information for liraglutide has not changed with the generic approval. The prescribing information carries a Boxed Warning about increased risk of thyroid C-cell tumors, and the drug should not be used by patients who have had medullary thyroid carcinoma or have family members who have had it, or who have multiple endocrine neoplasia syndrome type 2 [2]. The label also warns about pancreatitis, pen sharing, low blood sugar when used with insulin or sulfonylureas, kidney problems, hypersensitivity and acute gallbladder disease. Common side effects in trials included nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation [2].

More than 38 million Americans have diabetes, and 90% to 95% of them have type 2 diabetes, according to the CDC [2].

What happens next

FDA's page gives one dated milestone: Saxenda is listed as available until discontinuation in January 2027 [3]. For Victoza, the estimated shortage duration remains "TBD" [3]. The agency has not disclosed when the overall liraglutide shortage listing will be resolved [3].

Sources

  1. https://api.fda.gov/drug/shortages.json?search=generic_name%3A%22liraglutide%22
  2. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes
  3. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Liraglutide+Injection&st=c

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