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Ozempic’s Generic Name — and Why There Is No Generic Ozempic

Semaglutide is the generic name and Ozempic is a brand. That is a different question from whether a generic is on sale: none is approved in the United States, one is tentatively approved and blocked, and compounded semaglutide is not a generic at all.

Written by , who builds and maintains this site and is not a clinician. Every figure links to its primary source. · Last reviewed

The generic name of Ozempic is semaglutide. Ozempic is the brand; semaglutide is the nonproprietary name of the molecule, and it is the name the FDA files every one of these products under. Wegovy and Rybelsus contain the same active ingredient, so semaglutide is equally their generic name.

There is no generic Ozempic you can buy in the United States. Those two sentences look like they contradict each other, and the confusion is the reason this page exists: “generic name” and “a generic” are different things. One is what the drug is called. The other is a copy a regulator has approved.

Every US brand that contains semaglutide

BrandStrengthsApproved
Ozempic injectionNDA 2096370.25, 0.5, 1 and 2 mg pens5 Dec 2017
Rybelsus tabletsNDA 2130513, 7 and 14 mg20 Sep 2019
Wegovy injectionNDA 2152560.25 to 2.4 mg pens4 Jun 2021
Ozempic tabletsNDA 213051 — same application as Rybelsus1.5, 4 and 9 mg9 Dec 2024
Wegovy tabletsNDA 2183161.5, 4, 9 and 25 mg22 Dec 2025
Wegovy HD injectionNDA 2152567.2 mg/0.75 mL19 Mar 2026

Approval dates are per-strength dates from the FDA Orange Book product file, cross-checked against the application records in Drugs@FDA. Every row has the same applicant: Novo Nordisk.

Two of those rows surprise people. Oral semaglutide is sold under two brand names from a single application — Rybelsus at 3, 7 and 14 mg, and the higher strengths approved in December 2024, which the Orange Book lists as Ozempic tablets. And the 7.2 mg injection has its own brand, Wegovy HD. The full approval timeline.

What a generic actually is

The FDA’s own description sets the bar: a generic medicine is required to be the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability and quality, as well as in the way it is taken; the active ingredient is the same as in the brand-name drug; and the generic is bioequivalent to it. That review happens through an abbreviated application, and the FDA says a generic meeting its standards generally receives final approval once the brand’s patents and marketing exclusivities expire, or if the patents are successfully challenged.

Measured against that definition, the US answer is short. No semaglutide product from any company other than Novo Nordisk appears among the approved products in the Orange Book. There is no A-rated substitute your pharmacy can fill instead.

One generic is approved — and is not allowed on the market

This is the part almost every page misses. Apotex holds ANDA 220314 for semaglutide injection, and the FDA granted it a tentative approval on 7 April 2026. Three product strengths are covered. None of them can be sold.

The FDA’s glossary defines exactly what that status means: 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; FDA delays final approval until all patent or exclusivity issues have been resolved; and a tentative approval does not allow the applicant to market the generic drug product.

So a manufacturable, FDA-reviewed generic semaglutide exists on paper. What stands between it and a pharmacy shelf is a set of dates.

The dates in the way

Patent or exclusivityExpires
US patent 8,129,343Listed against all four semaglutide applications, flagged as both a drug substance and a drug product patent5 Dec 2031
US patents 9,278,123 / 11,382,957Oral formulation, listed against the tablet applications16 Dec 2031
Exclusivity I-935New indication, listed against Wegovy injection and tablets8 Mar 2027
Exclusivity I-973New indication, Wegovy injection15 Aug 2028
Exclusivity NPNew product, Wegovy tablets22 Dec 2028
Exclusivity NSNew strength, Wegovy HD 7.2 mg19 Mar 2029

A selection, not the whole list — the Orange Book carries dozens of device, formulation and method-of-use patents against these applications, several running to 2038 and beyond. Expiry dates are as submitted by the applicant and can change through extension, delisting or litigation, so treat them as the current state of a file rather than as a forecast.

The one to watch is US 8,129,343, expiring 5 December 2031. It is the only patent flagged as covering the drug substance itself and listed against every semaglutide application — Ozempic, Rybelsus, Wegovy injection and Wegovy tablets alike. Two older ones have already gone: US 8,536,122 expired 20 March 2026 and RE46,363 on 3 August 2026, and their expiry changed nothing about availability.

No credible source publishes a US launch date for generic semaglutide, and this page will not invent one. What can be said with a source behind it is that a tentative approval exists, and that the substance patent on file runs to December 2031.

Compounded semaglutide is not a generic

It is the substitution most people actually encounter, and it sits in a different legal category altogether. A generic is reviewed and approved. A compounded drug is not: compounded drugs are not FDA approved, and in the agency’s words, this means it does not review compounded drugs for safety, effectiveness or quality before they are marketed.

  • It may not even be the same active ingredient. The FDA has stated that salt forms including semaglutide sodium and semaglutide acetate are different active ingredients than are used in the approved drugs. A generic, by definition, cannot differ there.
  • The harm is measured. As of 31 May 2026 the FDA had received 990 adverse event reports for compounded semaglutide, and has reported adverse events, some requiring hospitalisation, that may be related to dosing errors with compounded injectable semaglutide.
  • The shortage justification is gone. The FDA determined the semaglutide injection shortage resolved on 21 February 2025, with compounding under section 503A to stop by 22 April 2025 and under section 503B by 22 May 2025.
  • Adding an ingredient does not change that. The FDA has said it may consider a compounded product combining semaglutide with another active ingredient, such as vitamin B12, to be essentially a copy of a commercially available drug product.

There is one practical tell worth knowing: every approved semaglutide injection is a ready-to-use solution. If it arrived as a powder you have to reconstitute, it did not come from an approved application.

Outside the US, generic semaglutide is real

Health Canada’s Drug Product Database tells a different story from the Orange Book. Generic semaglutide injections are authorised there, and two are marketed: Dr Reddy’s semaglutide injection from 6 May 2026 and Apotex’s APO-SEMAGLUTIDE INJECTION from 14 May 2026. Two more — Apotex’s SEVMIA and Aspen Pharmacare’s semaglutide products — are authorised but recorded as approved rather than marketed.

That is a statement about Canadian regulatory status and nothing else. A drug approved by one regulator is not an approved drug everywhere, and none of those products has an FDA approval.

Is semaglutide the same as Ozempic?

Yes — Ozempic contains semaglutide and no other active ingredient. What differs between the brands is the label, not the molecule:

  • Ozempic injection — type 2 diabetes, cardiovascular risk reduction and kidney-related risk reduction. Maximum 2 mg weekly.
  • Wegovy injection — weight reduction, cardiovascular risk reduction and MASH. Maximum 7.2 mg weekly.
  • Rybelsus and the oral brands — the same molecule as a tablet, taken daily, formulated with the absorption enhancer SNAC.

Because they are one molecule, everything pharmacokinetic transfers between them: the half-life is about a week whichever box it came in.

And the spelling

Ozempic is searched as ozampic, ozempec and ozempic semaglutide often enough to be worth saying once: they are all the same product, and there is no drug called ozampic. If a site sells something under a misspelt brand name, that is a signal about the seller, not a variant of the drug.

Related

Common questions

Sources

Every number on this page comes from one of the documents below. Where no reliable source exists, the page says so instead of filling the gap.

  1. RegulatorFDA / CDER· 2026-09
    Drugs@FDA — application and approval records for semaglutide (NDA 209637, 213051, 215256, 218316) and tirzepatide (NDA 215866, 217806)
  2. RegulatorFDA· 2026-09
    Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) — product, patent and exclusivity data files
  3. RegulatorFDA
    Generic Drug Facts
  4. RegulatorFDA
    Drugs@FDA Glossary of Terms — tentative approval, abbreviated new drug application, therapeutic equivalence
  5. FDA labelFDA / DailyMed· 2026-05
    OZEMPIC (semaglutide) injection — FDA prescribing information
  6. FDA labelFDA· 2026-03
    WEGOVY (semaglutide) injection and tablets — FDA prescribing information
  7. FDA labelFDA / DailyMed
    RYBELSUS / OZEMPIC (semaglutide) tablets — FDA prescribing information
  8. RegulatorFDA· 2026-09-01
    FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
  9. RegulatorFDA· 2026-04-01
    FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
  10. RegulatorHealth Canada· 2026-09
    Drug Product Database — semaglutide product, marketing status and active ingredient records