Hybio liraglutide listing shows a marketing start date six months before FDA approval
A federal drug directory gives one liraglutide product a start date six months ahead of its approval date, a reminder that a listing date does not prove a medicine was on pharmacy shelves.
A Hybio Pharmaceutical liraglutide injection appears in an FDA drug directory with a marketing start date of June 21, 2024 — about six months before the agency approved the application that covers it, according to federal records [1][2].
The FDA drug code directory lists a single-pen Hybio liraglutide 18 mg/3 mL presentation under application ANDA215503 with a marketing start date of June 21, 2024 [1]. Drugs@FDA records ANDA215503, with Hikma listed as the applicant, as approved on December 23, 2024 [2]. Hybio's two-pen and three-pen cartons for the same product carry marketing start dates of December 24, 2024 [1].
That gap makes the June 2024 date a listing-record anomaly. It is not evidence that a generic liraglutide reached US patients before the FDA approved it. The directory and the approval database are separate records, and the directory carries the agency's own warning that its results are unvalidated and should not be used to make decisions about medical care [1].
The first generic liraglutide a US patient could buy was Teva's authorized generic, listed in directory records with a June 24, 2024 start date [1]. An authorized generic is a brand manufacturer's product sold under a generic label rather than an independently approved copy. Teva's liraglutide is recorded under ANDA214568; one five-pen carton carries a marketing start date of August 28, 2025 and a marketing end date of September 30, 2027 [1].
Other copies followed. Meitheal Pharmaceuticals lists two- and three-pen liraglutide cartons under ANDA218115 with a start date of April 2, 2025 [1]. Biocon Pharma's ANDA215245 was approved on March 11, 2026 [2].
Liraglutide is a once-daily injectable GLP-1 medicine. Novo Nordisk sells it as Victoza, listed under NDA022341 with a marketing start date of January 25, 2010, and also as Saxenda [1]. It is a different molecule from semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound) and orforglipron (Foundayo). Nothing in these liraglutide records describes semaglutide, tirzepatide or orforglipron products.
Why it matters for patients
A marketing start date in a government directory is not proof that a product was on pharmacy shelves. A person who finds a June 2024 date while looking for a lower-cost generic liraglutide is seeing a listing record, not a shipment.
What a pharmacy stocks, and what an insurer covers, depends on the pharmacy's supplier and on an individual plan. The drug code directory does not contain prices, and the agency says the data should not be relied on for medical care decisions [1].
Because the June 2024 entry runs six months ahead of the approval date, a date alone cannot establish when a generic first became purchasable. Records for one company's liraglutide products can also carry different start dates for different carton sizes [1].
What happens next
The FDA has not reported whether the June 21, 2024 start date for the Hybio single-pen presentation will be corrected or removed [1].
The most recent approval date in the liraglutide application records is Biocon Pharma's ANDA215245 on March 11, 2026 [2]. Teva's five-pen liraglutide carton is listed with a marketing end date of September 30, 2027 [1]. No further dates for liraglutide generic launches have been disclosed.
Sources
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