Meitheal launches generic liraglutide injection as Victoza shortage continues
A new generic version of liraglutide is now listed with the FDA while the brand-name Victoza remains on shortage lists, adding a supplier to the market.
Meitheal Pharmaceuticals has received FDA approval for and launched a generic liraglutide injection, 18 mg/3 mL, under application number ANDA218115 [1]. The company said the product is its first injector-pen medicine, and that it is reaching the market while the brand-name version, Novo Nordisk's Victoza, is listed as in active shortage [1].
FDA's National Drug Code directory shows two Meitheal carton sizes, both with a marketing start date of April 2, 2025. NDC 71288-563-84 contains three 3 mL plastic syringes; NDC 71288-563-85 contains two [2]. The strength is listed as 6 mg/mL, which works out to 18 mg in each 3 mL syringe [2]. The listing expiration date is Dec. 31, 2027 [2].
The active ingredient is liraglutide, which FDA classifies as a GLP-1 receptor agonist [2]. Victoza also appears in the FDA directory at 6 mg/mL, listed under NDA022341 with Novo Nordisk as the labeler and a marketing start date of Jan. 25, 2010 [2]. Meitheal's entry carries the marketing category "ANDA," the abbreviated new drug application pathway used for generic versions of drugs that already hold FDA approval [2].
Meitheal said Victoza was in active shortage on both the FDA and ASHP shortage lists as of March 24, 2025 [1]. A search of FDA's NDC directory for the generic name liraglutide returns 62 records, a set that includes finished brand and generic products along with bulk ingredient listings that are not medicines sold to patients [2].
Pricing, manufacturing volume and how widely the new product will be stocked have not been disclosed. It also has not been reported whether the Meitheal launch has changed the shortage status of Victoza on either list.
Why it matters for patients
Liraglutide is a GLP-1 receptor agonist, the same broad drug class as semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound), but it is a different molecule [2]. For people who take liraglutide, a second supplier in a market where the brand has been scarce is a practical change: the same active ingredient may now reach pharmacies under a different name and label [1][2].
How that plays out for any individual prescription depends on factors that are not settled by an approval. Whether a pharmacy stocks the Meitheal product, whether a prescriber writes for it by name, and what a patient's insurance covers have not been reported. Generic approvals do not guarantee availability at a given pharmacy on a given day, and a shortage list entry is a national snapshot rather than a promise about any one counter [1].
People with questions about their own liraglutide prescription, including whether a different manufacturer's version can be dispensed, are handled case by case by prescribers and pharmacists; nothing in the approval announcement changes what a prescription says [1].
What happens next
FDA and ASHP each maintain public shortage lists, and Meitheal pointed to those lists as the reason for the launch timing [1]. The most recent status the company cited was dated March 24, 2025 [1]. No timeline has been given for when the Victoza shortage might end, and no supply projections or launch prices for the Meitheal product have been made public [1].
Sources
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