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

By Ruth Calder, Enforcement Editor (https://glpwatchdog.org/authors/ruth-calder) | Published: 2026-08-21 | Updated: 2026-11-10

Canonical page: https://glpwatchdog.org/research/generic-glp1s-what-exists

> 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.

## Key points

- Liraglutide has 11 approved generic applications, all cleared for marketing; the first was approved December 23, 2024, and the most recent on July 1, 2026.
- Semaglutide has one generic application, granted TENTATIVE approval on April 7, 2026, which FDA states does not allow marketing.
- Tirzepatide and dulaglutide have no generic applications on file at all.
- Anything sold as “generic semaglutide” today is a compounded preparation, a different regulatory category.

One GLP-1 has generics a pharmacy can dispense, 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 comes from FDA’s own application database, most recently read on October 17, 2026.[1]

## What FDA's database 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 October 17, 2026.[1]*

| Molecule | Generic applications | Can be marketed? |
| --- | --- | --- |
| Liraglutide | **11** | Yes — all eleven |
| Exenatide | 1 | No — listed as discontinued |
| Semaglutide | 1 | **No** — tentative approval only |
| Tirzepatide | 0 | — |
| Dulaglutide | 0 | — licensed as a biologic, so a copy would be a biosimilar, not an ANDA |

The liraglutide generics arrived steadily rather than all at once. Hikma was first, approved December 23, 2024. Then Nanjing King Friend in April 2025, Lupin in July, Teva in August. Seven 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 July 1, 2026.[1] Those eleven applications belong to nine companies, since Biocon and Orbicular hold two each. All eleven carry a marketing status of Prescription and a therapeutic-equivalence code, meaning a pharmacist can substitute them for the brand. Cheaper liraglutide does not close the gap with semaglutide on weight. STEP 8 compared [the molecules in Saxenda and Ozempic](https://glpwatchdog.org/compare/drugs/saxenda-vs-ozempic) head to head at their weight doses, and semaglutide 2.4 mg took off 15.8% against 6.4% on liraglutide 3.0 mg.

## 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 April 7, 2026, and the marketing status on every one of those three strengths reads “None (Tentative Approval)”.[3] That is not the approval the liraglutide products hold.

> 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 but not 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.

Drugs@FDA lists only applications FDA has acted on, so it is not the whole queue. Novo Nordisk’s half-year 2026 report discloses another: Cipla has filed an ANDA for a generic Ozempic, with Paragraph IV certifications challenging the listed patents, and Novo has sued Cipla for patent infringement in federal court in New Jersey.[5] A filed application and a lawsuit are only the start of the road to a generic. Neither puts a product on a shelf.

> 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](https://glpwatchdog.org/research/compounded-glp1-going-away-what-to-do)).

A compounded preparation is at least something you can trace, if the seller tells you who made it. [Jently](https://glpwatchdog.org/reviews/jently) names Precision Compounding Pharmacy, a 503A in New York, and [DreamHug Medical](https://glpwatchdog.org/reviews/dreamhug-medical) names Belmar in Arizona. [KIN Health](https://glpwatchdog.org/reviews/kin-health) and [AJ Peptide](https://glpwatchdog.org/reviews/aj-peptide) also name their pharmacies. [Trally Meds](https://glpwatchdog.org/reviews/trally-meds) sells compounded semaglutide without naming one, so that is the first question to ask there.

## Why eleven generics of one drug and none of another

Liraglutide is 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 generic lifecycle: protection, then expiry, then competition.

Approval has not ended the shortage. FDA’s drug shortage database still lists liraglutide injection as currently in shortage, a status first posted on July 18, 2023. Victoza presentations show limited availability, and the Saxenda entry says it will be available until its discontinuation in January 2027.[6] A generic on the books does not guarantee one at your pharmacy this week.

Tirzepatide and dulaglutide sit at the other end of that cycle, with no generic applications on file at all. Semaglutide is in the middle, with one application approved in principle and waiting on the patents. When that wait ends is not something we predict.

What it does change is how you read a price. Competition among nine suppliers of one molecule does not touch the price of a different molecule. For what any of this costs today, our [live price tracker](https://glpwatchdog.org/price-tracker) carries a dated figure for every seller we can find, and the [methodology](https://glpwatchdog.org/methodology) explains how each one is checked.

Generic liraglutide is also the one GLP-1 where an online pharmacy can show you the economics. [Cost Plus Drugs](https://glpwatchdog.org/reviews/cost-plus-drugs) lists generic liraglutide for Saxenda, prints the manufacturer cost, markup and labor fee behind its price, and lists no Ozempic, Wegovy, Zepbound or Mounjaro. It does no prescribing, so the prescription has to come from your own clinician. Sellers that do prescribe it, generic or compounded, are on our [liraglutide providers board](https://glpwatchdog.org/best/liraglutide-providers). For semaglutide, the choices remain the brand or a compounded version: [Noom Med](https://glpwatchdog.org/reviews/noom-med) prescribes brand Wegovy and also runs a compounded semaglutide microdose program, and [Prime Doctor RX](https://glpwatchdog.org/reviews/prime-doctor-rx) sells compounded semaglutide as a weekly injection or a daily tablet, while [SkyRx](https://glpwatchdog.org/reviews/skyrx) sells it as an injection or as oral drops on a 12-month plan paid up front.

## What this does and does not mean for you

- A generic liraglutide is a real, substitutable product. Nine manufacturers hold eleven approvals to market one, though liraglutide injection is still on FDA’s shortage list.
- There is no generic semaglutide, tirzepatide or dulaglutide you can be dispensed today. A second semaglutide filing, Cipla’s, is tied up in patent litigation.
- “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. A generic tells you about supply, not about which drug suits you; that conversation belongs with your prescriber.

## Frequently asked questions

### Is there a generic Ozempic or Wegovy?

No, not one you can be dispensed. Apotex holds a generic semaglutide application, but FDA granted it tentative approval on April 7, 2026, and a tentative approval does not permit marketing. Cipla has filed another, and Novo Nordisk has sued over it. Anything currently advertised as generic semaglutide is a compounded preparation rather than an FDA-approved generic.

### Which GLP-1 has a real 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 July 1, 2026. Liraglutide injection is still listed as in shortage, so supply can be patchy. Exenatide's single approved generic is listed as discontinued.

### What does tentative approval mean?

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.

### Will a generic make semaglutide cheaper?

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.

### Should I switch to liraglutide because it has a generic?

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. US Food and Drug Administration Drugs@FDA: FDA-Approved Drugs — application records queried by active ingredient (liraglutide, semaglutide, tirzepatide, dulaglutide, exenatide), read August 21 and October 17, 2026. Drugs@FDA (accessdata.fda.gov). 2026. https://www.accessdata.fda.gov/scripts/cder/daf/
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. US Food and Drug Administration ANDA 220314 (semaglutide injection, Apotex Inc) — application overview, tentative approval April 7, 2026. Drugs@FDA. 2026. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220314
4. US Food and Drug Administration ANDA 215503 (liraglutide injection, Hikma) — application overview, approved December 23, 2024. Drugs@FDA. 2024. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215503
5. Novo Nordisk A/S Financial report for the period January 1, 2026 to June 30, 2026 — Legal matters: Ozempic ANDA patent litigation. Form 6-K filed with the US Securities and Exchange Commission. 2026. https://www.sec.gov/Archives/edgar/data/353278/000035327826000023/caq22026.htm
6. US Food and Drug Administration FDA Drug Shortages — Liraglutide Injection (Currently in Shortage). FDA Drug Shortages database. 2026. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Liraglutide%20Injection&st=c

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Cite as: GLP Watchdog, Ruth Calder, "Generic GLP-1s: Eleven for Liraglutide, and None You Can Buy for Semaglutide", published 2026-08-21, updated 2026-11-10. https://glpwatchdog.org/research/generic-glp1s-what-exists

Canonical HTML page: https://glpwatchdog.org/research/generic-glp1s-what-exists

Medical disclaimer: Nothing here is medical advice. We report on this subject; we do not treat anyone. Whether to begin a medication, supplement, or treatment, whether to adjust it, and whether to stop are questions for a clinician licensed to answer them, who knows your history.