Regulatory status

Is there a generic semaglutide in the US?

Status as of September 14, 2026. Every source on this page was checked on that date and is listed at the bottom.

Is there a generic semaglutide in the US?

No. FDA publishes every approved drug product in Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book. On September 14, 2026 the Orange Book product file carried 29 semaglutide entries. All 29 are New Drug Applications held by Novo Nordisk — the products marketed as Ozempic®, Wegovy® and Rybelsus®. None of the 37,875 abbreviated new drug application entries in that file is for semaglutide.

There is one semaglutide abbreviated application on record. ANDA 220314, filed by Apotex Inc for semaglutide injection in 2 mg/3 mL, 4 mg/3 mL and 8 mg/3 mL strengths, received a tentative approval on April 7, 2026. Drugs@FDA records its marketing status as "None (Tentative Approval)" and its therapeutic equivalence code as "None." FDA's Orange Book preface explains what that means: "The Agency will not include drug products with tentative approvals in the Orange Book because a drug product that is granted tentative approval is not an approved drug product." It cannot be sold in the United States.

A third FDA source agrees. FDA's First Generic Drug Approvals list — which records "the first approval by FDA which permits a manufacturer to market a generic drug product in the United States" — contained no semaglutide entry when checked on September 14, 2026.

What is a generic drug, exactly?

"Generic" is not a marketing adjective. It is a specific regulatory status. A generic drug reaches the US market through an abbreviated new drug application under section 505(j) of the Federal Food, Drug, and Cosmetic Act. FDA describes the pathway this way: "Generic drug applications are termed 'abbreviated' because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product performs in the same manner as the innovator drug." That demonstration is bioequivalence.

Approval is only half of it. FDA also rates approved products for interchangeability in the Orange Book. Per the Orange Book preface, "Approved drug products are considered to be therapeutic equivalents if they are pharmaceutical equivalents for which bioequivalence has been demonstrated, and they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling." A product that is not in the Orange Book has no such rating at all.

So a real generic carries three things a compounded preparation does not: an FDA approval, an Orange Book listing, and a therapeutic equivalence evaluation.

What happened in Canada?

Canada authorized semaglutide products from manufacturers other than Novo Nordisk, and that is what most of the "generic semaglutide" news is about. Health Canada's Drug Product Database lists SEMAGLUTIDE INJECTION from Dr. Reddy's Laboratories Ltd, DIN 02567806, with an approved product monograph dated April 28, 2026 and a current status of "Marketed" recorded as of May 6, 2026. It also lists APO-SEMAGLUTIDE INJECTION from Apotex Inc, DIN 02568012, monograph dated May 1, 2026, marketed from May 14, 2026, plus further semaglutide injection listings from Aspen Pharmacare Canada.

Note who that second company is. Apotex markets a semaglutide injection in Canada and, in the United States, holds only a tentative approval that does not permit sale. Same company, two regulators, two different answers — which is exactly why a Canadian headline tells you nothing about US availability.

It also does not create a back door. FDA's guidance on personal importation is blunt: "In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use because these products purchased from other countries often have not been approved by the FDA for use and sale in the U.S. If a drug is approved for use in another country but is an unapproved new drug in the U.S. it is illegal to import."

Is compounded semaglutide a generic?

No. FDA asks and answers this exact question in its compounding Q&A: "Are compounded drugs and generic drugs the same? No. A generic drug is approved by FDA under 505(j) of the FD&C Act and meets all of the requirements of that section (including establishing therapeutic equivalence to a brand name drug, among others), while a compounded drug is not approved by FDA."

The same page states the consequence plainly: "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed." Compounded medications are not FDA-approved and are not therapeutically equivalent to FDA-approved products.

This matters commercially, not just semantically. If a telehealth company calls what it sells "generic semaglutide" or "generic Ozempic," it is describing a regulatory status its product does not have. Announcing 30 warning letters to telehealth companies on March 3, 2026, FDA said the primary violations included "making claims implying sameness with FDA-approved products and obscuring product sourcing by advertising drug products branded with the telehealth firm's name or trademark without qualification, implying they are the compounder" — and restated the point this page is built on: "Compounded drugs are also not the same as generic drugs, which are FDA-approved."

For a fuller explanation of what compounding is and who is allowed to do it, see what compounded semaglutide is and the current legal status of compounded semaglutide.

Three different things, side by side

Brand names are registered trademarks of their respective owners. Compounded medications are not FDA-approved and are not therapeutically equivalent to FDA-approved products.

When could a US generic exist?

There is no announced date, and Cora Health will not publish a guess. What can be stated is the mechanism. FDA's Generic Drug Facts page explains: "A generic drug that meets FDA's scientific standards for approval generally can receive final FDA approval once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic drug company)." That is what a tentative approval like ANDA 220314 is waiting on.

The patents themselves are public. On September 14, 2026 the Orange Book patent file carried 92 patent entries listed against the Ozempic® NDA and 115 against the Wegovy® NDA, with listed expiration dates running from January 2026 out to February 17, 2041. Patent listings are added and removed over time, and litigation and settlement terms that affect launch timing are frequently not public.

The practical instruction: check the Orange Book entry for the current list, and treat any specific launch date you see quoted — including a date on this page, once it ages — as something to re-verify rather than rely on.

Is "generic Ozempic" a real product you can buy?

No. There is no FDA-approved generic version of Ozempic® on the US market, so a US seller advertising "generic Ozempic" is not describing an approved product. Usually the phrase is being applied to compounded semaglutide, which is a different thing with a different regulatory status: not FDA-approved, not therapeutically equivalent to the brand, and prepared by a state-licensed pharmacy for an individual patient under a prescription.

The useful way to read that phrase is as information about the seller. A company willing to describe a compounded preparation as a generic is a company willing to describe its regulatory status inaccurately. Before buying from any telehealth provider, check that it names its compounding pharmacy, states plainly that compounded medications are not FDA-approved, and discloses the full price with its billing terms. Cora Health's pharmacy partners are named on the pharmacy partners page, and its certification can be verified independently through LegitScript.

What do licensed providers prescribe through Cora Health?

Compounded semaglutide — not a generic, and not FDA-approved. Cora Health does not prescribe medication; licensed providers at Wasef Health, PC evaluate each patient and prescribe when clinically appropriate, and the medication is compounded by Hallandale Pharmacy (PCAB-accredited 503A) or VialsRx (US-licensed 503A). Both pharmacies are named publicly so patients can verify their credentials with state pharmacy boards independently.

Through Cora Health, compounded semaglutide is $99/month on Cora Health's Essential annual plan, billed $1,188 every 12 months and renewing automatically until cancelled, or $175/month on the monthly plan. Either way the price covers the licensed-provider consultation, the medication, free expedited shipping and ongoing provider monitoring, with no separate membership fee. A plan renews automatically until you cancel, and you can cancel or pause at any time — see the refund and cancellation policy for how it works on longer plans. For the full cost breakdown and how it compares to brand-name list prices, see what compounded semaglutide costs and compounded versus brand-name GLP-1s. Definitions of the regulatory terms on this page are collected in the glossary.

Frequently asked questions

Is there a generic semaglutide in the US?

No. As of September 14, 2026, the FDA Orange Book lists no approved generic semaglutide in the United States. Every approved semaglutide product listed in the Orange Book is held by Novo Nordisk under a New Drug Application — Ozempic, Wegovy and Rybelsus. One abbreviated new drug application for semaglutide injection, ANDA 220314 from Apotex Inc, received tentative approval from FDA on April 7, 2026, but tentative approval is not approval: FDA states that "a drug product that is granted tentative approval is not an approved drug product," and it cannot be marketed in the US.

What is a generic drug, exactly?

A generic drug is a product FDA has approved through an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act. The applicant does not repeat the original clinical trials; instead it must show the product is bioequivalent to an approved reference product and matches it in active ingredient, strength, dosage form, route of administration and labelling. FDA then lists the approved generic in the Orange Book and, for multisource products, assigns a therapeutic equivalence rating. Approved generics are, in FDA's words, "therapeutic equivalents if they are pharmaceutical equivalents for which bioequivalence has been demonstrated."

What happened in Canada with generic semaglutide?

Canada is not the United States, and Canadian approvals have no legal effect here. Health Canada's Drug Product Database lists SEMAGLUTIDE INJECTION from Dr. Reddy's Laboratories Ltd (DIN 02567806) with an approved product monograph dated April 28, 2026 and a status of "Marketed" as of May 6, 2026, and APO-SEMAGLUTIDE INJECTION from Apotex Inc (DIN 02568012), monograph dated May 1, 2026, marketed from May 14, 2026. Apotex is the same company whose US application for semaglutide injection holds only a tentative approval. FDA is explicit that "if a drug is approved for use in another country but is an unapproved new drug in the U.S. it is illegal to import."

Is compounded semaglutide a generic?

No, and FDA answers this question directly: "Are compounded drugs and generic drugs the same? No. A generic drug is approved by FDA under 505(j) of the FD&C Act and meets all of the requirements of that section (including establishing therapeutic equivalence to a brand name drug, among others), while a compounded drug is not approved by FDA." Compounded semaglutide is prepared by a state-licensed pharmacy for an individual patient under a prescription. It is not FDA-approved, it is not listed in the Orange Book, and it carries no therapeutic equivalence rating — it is not therapeutically equivalent to Ozempic®, Wegovy® or any other FDA-approved product. FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed.

When could a generic semaglutide be approved in the US?

There is no announced date, and anyone quoting one is guessing. FDA explains the mechanism rather than a timetable: "A generic drug that meets FDA's scientific standards for approval generally can receive final FDA approval once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic drug company)." The Orange Book lists 92 patent entries against the Ozempic NDA and 115 against the Wegovy NDA, with listed expiration dates running from January 2026 out to February 17, 2041. Patent listings change, and litigation and settlement terms that affect timing are often not public. Check the Orange Book entry for the current list rather than relying on any date published elsewhere.

Is "generic Ozempic" a real product you can buy in the US?

No. There is no FDA-approved generic version of Ozempic® on the US market, so any US seller advertising "generic Ozempic" is describing something that does not exist as an approved product. In practice the phrase is usually being used to describe compounded semaglutide, which is a different thing with a different regulatory status: not FDA-approved, not therapeutically equivalent to the brand, and prepared by a state-licensed pharmacy for an individual patient. Treat "generic Ozempic" as a warning sign about the seller rather than a description of the product.

What do licensed providers prescribe through Cora Health?

Compounded semaglutide — not a generic, and not FDA-approved. Cora Health does not prescribe medication; licensed providers at Wasef Health, PC evaluate each patient and prescribe when clinically appropriate, and the medication is compounded by Hallandale Pharmacy (PCAB-accredited 503A) or VialsRx (US-licensed 503A).

Sources

Every source below was retrieved on September 14, 2026. Where FDA or Health Canada publishes its own currency stamp for a page or data file, that stamp is given too.

• FDA — Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Search interface. Read September 14, 2026.
• FDA — Orange Book Data Files. Product and patent counts on this page come from the downloadable files, data dated September 11, 2026, retrieved September 14, 2026.
• FDA — Orange Book Preface, sections 1.1 and 1.2 (tentative approval, therapeutic equivalence). FDA content current as of January 15, 2026; read September 14, 2026.
• FDA — Drugs@FDA record for ANDA 220314 (Apotex Inc, semaglutide injection; tentative approval April 7, 2026). Read September 14, 2026.
• FDA — Abbreviated New Drug Application (ANDA). FDA content current as of May 20, 2026; read September 14, 2026.
• FDA — Generic Drug Facts. FDA content current as of November 1, 2021; read September 14, 2026.
• FDA — First Generic Drug Approvals. FDA content current as of September 1, 2026; read September 14, 2026, with no semaglutide entry present.
• FDA — Compounding and the FDA: Questions and Answers. FDA content current as of September 16, 2025; read September 14, 2026.
• FDA — Personal Importation. FDA content current as of August 18, 2025; read September 14, 2026.
• FDA — press announcement, FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s, issued March 3, 2026. FDA content current as of March 3, 2026; read September 14, 2026.
• Health Canada — Drug Product Database, DIN 02567806 (SEMAGLUTIDE INJECTION, Dr. Reddy's Laboratories Ltd). Read September 14, 2026.
• Health Canada — Drug Product Database, DIN 02568012 (APO-SEMAGLUTIDE INJECTION, Apotex Inc). Read September 14, 2026.
• LegitScript — certification record for trycora.io. Read September 14, 2026.

Looking at compounded semaglutide instead?

Cora Health connects you with licensed providers for a personalized evaluation. $99/month on Cora Health's Essential annual plan, billed $1,188 every 12 months and renewing automatically until cancelled. Compounded medications are not FDA-approved.