FDA approves two more generic liraglutide injections from Biocon and Orbicular
Two more generic versions of the liraglutide injection sold as Saxenda were cleared on the same day, adding supply options while pricing and coverage remain unannounced.
The FDA approved two more generic versions of the liraglutide injection sold under the brand name Saxenda on Feb. 24, 2026. The applications are Biocon Pharma's ANDA217063 and Orbicular's ANDA217234, and both were approved the same day, according to FDA application records [1][2].
Both are abbreviated new drug applications, the FDA pathway used to clear a generic version of a drug already on the market. Each record lists the product as a subcutaneous solution of liraglutide at 18 mg/3 mL, or 6 mg/mL, with prescription status [1][2]. Liraglutide is a GLP-1 receptor agonist, the same drug class as semaglutide and tirzepatide [1][2].
For the Biocon product, the listing names Biocon Pharma Inc. as the manufacturer, with package codes 70377-095-52 and 70377-095-53 [1]. For the Orbicular application, the listing names Orbicular Pharmaceutical Technologies Private Limited and Cipla USA Inc., with package codes under 81607-019 and 69097-910 [2]. Cipla USA's presence in the Orbicular record is consistent with the company distributing that product.
Both approvals were standard review, not priority review, and both were original submissions with a status date of Feb. 24, 2026 [1][2]. Each record carries the therapeutic equivalence code AP2 [1][2]. The two products come from separate sponsors and are separate applications [1][2].
The approval dates are the only dates the records provide. Neither record states when the products will reach pharmacies, what they will cost, or whether insurers will cover them [1][2].
Why it matters for patients
More approved versions of a prescription drug can mean more supply and, over time, more price competition. For people who use daily liraglutide injections, extra approvals expand the number of products a pharmacy could dispense. Whether these two products will cost less than the brand-name version, and whether pharmacy chains will stock them, has not been disclosed [1][2].
Generic liraglutide is not the same drug as semaglutide, sold as Ozempic, Wegovy and Rybelsus, or as tirzepatide, sold as Mounjaro and Zepbound. Those are different molecules with their own approval terms, and prescriptions are written for a specific product [1][2]. A pharmacist or prescriber can confirm which version a prescription is being filled with.
The FDA records do not list approved uses, dosing instructions or side-effect information for these two products. Those details appear in the prescribing information that accompanies an approved generic, not in the application database entries [1][2].
What happens next
No launch dates, prices or coverage decisions have been announced for either product [1][2]. The application records show approval only, and nothing in them indicates when manufacturing or shipping will begin [1][2].
Buying or switching any GLP-1 drug requires a prescription, and the records list both products as prescription-only subcutaneous injections [1][2]. Anyone with questions about which liraglutide product they receive can check the package label, which carries the manufacturer's name and a national drug code [1][2].
Sources
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