Data investigation

Generic GLP-1s: Eleven for Liraglutide, and None You Can Buy for Semaglutide

Liraglutide has eleven approved generics cleared for marketing. Semaglutide has one application, tentatively approved — which in FDA’s own words does not allow it to be sold. Tirzepatide has none.

By Ruth Calder · Enforcement Editor
Editorially reviewed & fact-checked against primary sources · How we verify contentLast reviewed
6 min read·4 citations

One GLP‑1 has generics you can actually be dispensed, and it is not the one you have heard of. Liraglutide has eleven approved generic applications, every one of them cleared for marketing. Tirzepatide and dulaglutide have none. Semaglutide has exactly one, and it carries a tentative approval — which in FDA’s own words does not allow it to be sold.[2] Every figure here was read from FDA’s own application database on 21 August 2026.[1]

What FDA's database actually shows

A generic is approved through an Abbreviated New Drug Application. Counting those applications per molecule is the cleanest answer to “is there a generic yet”, because it does not depend on anybody’s announcement. Here is the count, by active ingredient.

Generic (ANDA) applications by active ingredient, Drugs@FDA, read 21 August 2026.[1]
MoleculeGeneric applicationsCan be marketed?
Liraglutide11Yes — all eleven
Exenatide1Yes
Semaglutide1No — tentative approval only
Tirzepatide0
Dulaglutide0

The liraglutide generics arrived steadily rather than all at once. Hikma was first, approved 23 December 2024. Then Nanjing King Friend in April 2025, Lupin in July, Teva in August. Six more followed through 2026: Orbicular in January, Biocon and Orbicular again in February, Biocon in March, Fresenius Kabi at the end of March, Mylan in June and Sandoz on 1 July 2026.[1] All eleven carry a marketing status of Prescription and a therapeutic-equivalence code, meaning a pharmacist can substitute them for the brand.

The word doing the work is “tentative”

Apotex holds an application for generic semaglutide injection, in 2 mg/3 mL, 4 mg/3 mL and 8 mg/3 mL. FDA recorded its status as tentative approval on 7 April 2026, and the marketing status on every one of those three strengths reads “None (Tentative Approval)”.[3] That is a different thing from the approval the liraglutide products hold, and the difference is the whole point.

If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA issues a tentative approval letter to the applicant … A tentative approval does not allow the applicant to market the generic drug product.
FDA, Drugs@FDA Glossary of Terms

So the application cleared the science. What it has not cleared is the patent and exclusivity position on the brand. Until that resolves, there is no generic semaglutide to dispense, whatever a headline says. A pharmacy cannot order it and a prescriber cannot write for it.

⚠ This matters for what you may be offered online. A seller advertising “generic Ozempic” or “generic semaglutide” is not offering the Apotex product, because that product cannot be sold. They are almost certainly describing a compounded preparation, which is a different regulatory category with different rules — see what happened to compounded GLP-1s.

Why eleven generics of one drug and none of another

Liraglutide is simply older. It reached the US market years before semaglutide and tirzepatide, so its patent and exclusivity protections ran out first, and a queue of manufacturers was waiting. That is the ordinary lifecycle of a small-molecule-style approval pathway working exactly as designed: protection, then expiry, then competition.

Tirzepatide and dulaglutide sit at the other end of that cycle, with no generic applications on file at all. Semaglutide is in the middle: somebody has done the work and is waiting at the door. None of that is a prediction about when it opens, and this register will not make one.

What it does change is how you read a price. Competition among eleven suppliers of one molecule does not touch the price of a different molecule. If you want to know what any of this costs today rather than in principle, our live price tracker carries a dated figure for every seller we can find, and the methodology explains how each one is checked.

What this does and does not mean for you

  • A generic liraglutide is a real, substitutable product. Eleven manufacturers hold approval to market one.
  • There is no generic semaglutide, tirzepatide or dulaglutide you can be dispensed today.
  • “Tentative approval” is not a soft yes. FDA says plainly that it does not allow marketing.
  • Anything sold online as “generic semaglutide” is a compounded preparation, not an FDA-approved generic.
  • ⚠ Liraglutide is a daily injection and its trial outcomes are not interchangeable with semaglutide’s or tirzepatide’s. That a generic exists is a fact about supply, not advice about which drug suits you. That conversation belongs with your prescriber.

Frequently Asked Questions

No, not one you can be dispensed. One company holds a generic semaglutide application, but FDA granted it tentative approval on 7 April 2026, and a tentative approval does not permit marketing. Anything currently advertised as generic semaglutide is a compounded preparation rather than an FDA-approved generic.
Liraglutide, the molecule sold as Victoza and Saxenda. Eleven generic applications are approved and cleared for marketing, the first in December 2024 and the most recent on 1 July 2026. Exenatide also has one approved generic.
FDA issues it when a generic meets the requirements for approval but patents or exclusivity on the brand have not yet expired. The agency delays final approval until those resolve. In FDA's own words, a tentative approval does not allow the applicant to market the product.
Not while the only application is tentatively approved, because nothing is being sold to compete on price. Competition among generic suppliers of liraglutide has no bearing on what semaglutide costs, since they are different molecules.
That is a clinical question, not a supply one. Liraglutide is a daily injection and its trial results differ from those for semaglutide and tirzepatide. The existence of a generic tells you about availability and nothing about which drug is right for you; ask whoever prescribes for you.

References

  1. 1.US Food and Drug Administration Drugs@FDA: FDA-Approved Drugs — application records queried by active ingredient (liraglutide, semaglutide, tirzepatide, dulaglutide, exenatide), read 21 August 2026 Drugs@FDA (accessdata.fda.gov). 2026. https://www.accessdata.fda.gov/scripts/cder/daf/
  2. 2.US Food and Drug Administration Drugs@FDA Glossary of Terms — Tentative Approval FDA. 2026. https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms
  3. 3.US Food and Drug Administration ANDA 220314 (semaglutide injection, Apotex Inc) — application overview, tentative approval 7 April 2026 Drugs@FDA. 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220314
  4. 4.US Food and Drug Administration ANDA 215503 (liraglutide injection, Hikma) — application overview, approved 23 December 2024 Drugs@FDA. 2024. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215503

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