Ozempic Generic: When Will Generic Semaglutide Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Ozempic Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? 2031 to 2032 A wide window Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
  3. When does the last patent end? February 2041 37 patents listed with the FDA Why is a generic expected sooner?
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic semaglutide is expected to be available between 2031 and 2032, first for Ozempic 8 mg/3 mL. None is for sale yet. Each product has its own month below.

Why 2031 to 2032?

The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.

If Ozempic’s last patent runs to February 2041, how can a generic come sooner?

The 18 patents that run past the expected month, to February 2041 (10,933,120, 11,759,501, 11,759,502, 11,759,503 and 14 more), cover the product’s formulation, a way of using it and the active ingredient. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Here, a settlement between the companies sets the date. Generic companies have been challenging Ozempic’s patents with the FDA since December 2021. That is why the expected month comes before the last protection ends. See the road to a generic

Why hasn’t the FDA approved a generic yet?

That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).

Will the generic cost less?

Usually, and more so as more companies sell one. 4 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $331.90 pharmacies pay per mL for Ozempic today to about $89.61. See the price estimate

What should I do now?

Keep taking Ozempic as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you

  • 8 mg/3 mL2031 to 2032Likely · settlement between companies
  • 2 mg/3 mL2031 to 2032Probable · settlement between companies
  • 2 mg/1.5 mL2031 to 2033Very likely · settlement between companies
  • 4 mg/3 mL2031 to 2033Very likely · settlement between companies
  • tabletsSometime in 2033Probable · settlement expected

Our month is only an estimate based on available information, so we never name a day.

Ozempic by the Numbers

Reason
Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
How sure
Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
Price competition
Strong 4 companies have filed, 2 first in line
Brand sales
$39.6B a yearBlockbuster, 3 of its 5 products
  • FDA approved 2017 December 2017 FDA Orange Book
  • Patents listed 37 last runs to February 2041 A generic is expected sooner, between 2031 and 2032. See why FDA Orange Book
  • Pharmacies pay $331.90 per mL, up 6.7% in a year NADAC, October 2026
  • Medicare Part D spent $16.2B in 2025, for 2M people CMS Part D Spending by Drug
  • Medicaid prescriptions 3.6M in the last four reported quarters, $3.7B CMS Medicaid drug utilization, to Q1 2026

Ozempic’s Road to a Generic

Ozempic has had the market to itself since the FDA approved it in December 2017 (Novo Nordisk Inc). Its FDA protection (new use) runs to October 2028. Its 37 listed patents run to February 2041 (11 already expired). Generic companies have challenged its patents with the FDA since December 2021.

The first generic of Ozempic is expected between 2031 and 2032.

Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.

Brand alone on the market Since FDA approval, December 2017
New use Ends January 2028
New use Ends October 2028
Patent 10,888,605 Expires August 2038
Patent 11,752,198 Expires August 2038
Patent 12,295,988 Expires October 2038
Patent 11,833,248 Expires February 2039
Patent 12,396,953 Expires February 2039
Patent 11,318,191 Expires February 2041
Brand alone on the market FDA exclusivity Patent on the formulation Patent on a use First generic expected 31 more patents end earlier; every patent is in the table below. Swipe the chart sideways to see every year.

Why a Generic Can Come Before February 2041

The last listed patent runs to February 2041; a court ruling or a settlement can bring a generic sooner. Dr. Brian explains

Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.

Ozempic Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Ozempic’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.

Patents listed with the FDA (37)
PatentWhat it coversProtects untilStatus
9,108,002 The product’s formulation January 2026 Expired delisting requested
9,616,180 The product’s formulation January 2026 Expired delisting requested
9,861,757 The product’s formulation January 2026 Expired delisting requested
10,357,616 The product’s formulation January 2026 Expired delisting requested
10,376,652 The product’s formulation January 2026 Expired delisting requested
8,536,122 The active ingredient; the product’s formulation; a way of using it (U-3355, U-3469, U-2202, U-2628) March 2026 Expired
8,920,383 The product’s formulation July 2026 Expired delisting requested
9,775,953 The product’s formulation July 2026 Expired delisting requested
10,220,155 The product’s formulation July 2026 Expired delisting requested
11,097,063 The product’s formulation July 2026 Expired delisting requested
RE46363 The product’s formulation August 2026 Expired delisting requested
9,687,611 The product’s formulation February 2027 Active delisting requested
9,457,154 The product’s formulation September 2027 Active delisting requested
8,129,343 The active ingredient; the product’s formulation; a way of using it (U-2202, U-3355, U-3469, U-2628) December 2031 Active
9,278,123 The active ingredient; the product’s formulation; a way of using it (U-2628) December 2031 Active
10,086,047 The product’s formulation December 2031 Active
10,960,052 The product’s formulation December 2031 Active
11,382,957 The active ingredient; the product’s formulation December 2031 Active
9,132,239 The product’s formulation February 2032 Active delisting requested
10,933,120 The product’s formulation March 2033 Active
11,759,501 The product’s formulation March 2033 Active
11,759,502 The product’s formulation March 2033 Active
11,759,503 The product’s formulation March 2033 Active
12,594,326 The product’s formulation March 2033 Active
11,033,499 The product’s formulation; a way of using it (U-2628) June 2033 Active
10,335,462 The product’s formulation; a way of using it (U-2580, U-1852) June 2033 Active
10,278,923 The active ingredient; the product’s formulation; a way of using it (U-2628) May 2034 Active
12,239,739 The active ingredient; the product’s formulation; a way of using it (U-2628) May 2034 Active
12,514,822 A way of using it (U-2628) May 2034 Active
12,569,543 A way of using it (U-4446) April 2037 Active
10,888,605 The product’s formulation; a way of using it (U-1852) August 2038 Active
11,752,198 The product’s formulation; a way of using it (U-1852) August 2038 Active
12,214,017 The product’s formulation; a way of using it (U-1852) August 2038 Active
12,295,988 A way of using it (U-2628, U-1852) October 2038 Active
11,833,248 The product’s formulation; a way of using it (U-2628) February 2039 Active
12,396,953 The product’s formulation; a way of using it (U-2628) February 2039 Active
11,318,191 The product’s formulation; a way of using it (U-1852, U-4561) February 2041 Active
FDA exclusivities (2)
ExclusivityWhat it meansEndsStatus
New use I-961Three years of protection for a newly approved use (indication).January 2028Active
New use I-976Three years of protection for a newly approved use (indication).October 2028Active

Source: FDA Orange Book, application 209637, 213051. Patent numbers open the patent on Google Patents.

Patent Challenges to Ozempic

The first patent challenge to Ozempic reached the FDA in December 2021, from 7 companies on that first day. The FDA’s list has 5 entries for Ozempic, by form and strength. The FDA has not approved a first challenger’s generic yet.

What Is a Patent Challenge?

A generic company that wants to sell its version before Ozempic’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.

Patent challenges on the FDA’s list (5)
ProductFirst challengedCompanies that day180-day head startFirst challenger’s genericChallenged patents run to
ApprovedOn sale
Injection, 2 mg/1.5 mL and 4 mg/3 mL December 2021 7 companies No decision yet Not yet Not yet June 2033
Injection, 8 mg/3 mL December 2022 1 company No decision yet Not yet Not yet February 2032
Injection, 2 mg/3 mL April 2024 1 company No decision yet Not yet Not yet June 2033
Tablets, 3 mg, 7 mg and 14 mg July 2024 1 company No decision yet Not yet Not yet May 2034
Tablets, 1.5 mg, 4 mg and 9 mg December 2025 1 company No decision yet Not yet Not yet February 2039

Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.

Who Is Lined Up to Make Generic Semaglutide

Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.

1

Applied to the FDA

4 companies have applied to the FDA to make generic semaglutide.

The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.

First in line. 2 of them were first in line, both filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.

Generic companies have challenged Ozempic’s patents with the FDA since December 2021: see the patent challenges.

2

Approved by the FDA

Not yet. The FDA has not approved a generic semaglutide. Final approval often comes close to the day a generic can be sold.

3

For Sale in Pharmacies

Not yet. No company lists a generic semaglutide for sale with the FDA.

Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).

Ozempic Price: What Pharmacies Pay and What Generics Usually Do

What Pharmacies Pay for Ozempic 1 mg/dose (4 mg/3 mL) pen

$331.90 per mL in October 2026, up 6.7% from a year earlier.

Hover over or tap anywhere on the chart to see that month’s price.

  • Ozempic 0.25-0.5 mg/dose (2 mg/1.5 mL) pen $620.52 per mL
  • Ozempic 0.25-0.5 mg/dose (2 mg/3 mL) pen $331.99 per mL
  • Ozempic 1 mg/dose (4 mg/3 mL) pen $331.90 per mL
  • Ozempic 1.5 mg tablet $33.13 per tablet
  • Ozempic 2 mg/dose (8 mg/3 mL) pen $331.97 per mL
  • Ozempic 4 mg tablet $33.18 per tablet
  • Ozempic 9 mg tablet $33.18 per tablet
See the numbers
MonthPharmacies paid per mL
October 2026$331.90
September 2026$331.90
August 2026$331.90
July 2026$331.89
June 2026$331.91
May 2026$331.96
April 2026$331.99
March 2026$331.99
February 2026$331.99
January 2026$331.99
February 2024$311.13
January 2024$311.13

NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.

What a Generic Could Cost

What Pharmacies Pay for Ozempic Today$331.90per mL · October 2026
Our Estimate for Generic Ozempicabout $89.61per mL once generics reach pharmacies, about 73% less than today

How we estimate it. We start from what pharmacies pay for Ozempic today: $331.90 per mL for Ozempic 1 mg/dose (4 mg/3 mL) pen in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017). Ozempic has 4 companies lined up, so our estimate uses the figure for four companies. More companies would bring the price lower; fewer, less of a drop.

Dollar figures apply FDA’s median drops to the $331.90 pharmacies pay per mL today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.

Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.

What Medicare and Medicaid Spend on Ozempic

Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.

Medicare Part D Spending

What Medicare drug plans spent on Ozempic, before manufacturer rebates.

$4B
January to March 2026, the latest CMS has posted
For 1,459,326 people, about $1,387 per prescription fill
$16.2B
2025, the whole year
For 2,044,798 people, about $1,303 per prescription fill
See the numbers
PeriodSpendingPeoplePer fill
January to March 2026$3,963,607,2101,459,326$1,387.09
2025$16,153,040,2972,044,798$1,302.82

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Ozempic only, so no generic is counted in it. What CMS says it is used for: Semaglutide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems.

Medicaid Prescriptions by Quarter

3,640,645 prescriptions in the four quarters to Q1 2026, $3.7B paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 2026845,257$883,346,500
Q4 2025905,677$923,116,187
Q3 2025980,150$995,586,356
Q2 2025909,561$924,042,602
Q1 2025896,588$907,760,616

Source: CMS Medicaid State Drug Utilization Data, over Ozempic’s own package codes.

Ozempic Strengths and Forms

StrengthFormHow it is takenApprovedStatus
4MG/3ML (1.34MG/ML)SolutionSubcutaneousApril 2019Prescription reference product
8MG/3ML (2.68MG/ML)SolutionSubcutaneousMarch 2022Prescription reference product
2MG/3ML (0.68MG/ML)SolutionSubcutaneousOctober 2022Prescription reference product
1.5MGTabletOralDecember 2024Prescription reference product
4MGTabletOralDecember 2024Prescription reference product
9MGTabletOralDecember 2024Prescription reference product
0.25MG/0.5ML (0.25MG/0.5ML)SolutionSubcutaneousMay 2026Prescription reference product
0.5MG/0.5ML (0.5MG/0.5ML)SolutionSubcutaneousMay 2026Prescription reference product
1MG/0.5ML (1MG/0.5ML)SolutionSubcutaneousMay 2026Prescription reference product
2MG/1.5ML (1.34MG/ML)SolutionSubcutaneousDecember 2017Discontinued reference product

Source: FDA Orange Book, Novo Nordisk Inc. Listed for sale today by Novo Nordisk, A-S Medication Solutions and Novo Nordisk Pharmaceutical Industries, LP (FDA NDC Directory).

Ozempic NDC Codes and Packages

Each Ozempic package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.

Ozempic packages (22)
NDCProductPackageCompany
00169-4132-121.34 mg/mL injection, solutionsyringe of 1.5 mLNovo Nordisk
00169-4132-971.34 mg/mL injection, solutionsyringe of 1.5 mLNovo Nordisk
00169-4136-021.34 mg/mL injection, solutioncarton of 2 syringes of 1.5 mLNovo Nordisk
00169-4181-13SEMAGLUTIDE .68 mg/mL injection, solutionsyringe of 3 mLNovo Nordisk Pharmaceutical Industries, LP
00169-4181-13SEMAGLUTIDE .68 mg/mL injection, solutionsyringe of 3 mLNovo Nordisk Pharmaceutical Industries, LP
00169-4181-97SEMAGLUTIDE .68 mg/mL injection, solutionsyringe of 3 mLNovo Nordisk Pharmaceutical Industries, LP
00169-4181-97SEMAGLUTIDE .68 mg/mL injection, solutionsyringe of 3 mLNovo Nordisk Pharmaceutical Industries, LP
50090-8027-00SEMAGLUTIDE .68 mg/mL injection, solutionsyringe of 3 mLA-S Medication Solutions
Show the other 14 Ozempic packages
NDCProductPackageCompany
00169-4130-13SEMAGLUTIDE 1.34 mg/mL injection, solutionsyringe of 3 mLNovo Nordisk Pharmaceutical Industries, LP
00169-4130-13SEMAGLUTIDE 1.34 mg/mL injection, solutionsyringe of 3 mLNovo Nordisk Pharmaceutical Industries, LP
50090-5949-00SEMAGLUTIDE 1.34 mg/mL injection, solutionsyringe of 3 mLA-S Medication Solutions
50090-5949-00SEMAGLUTIDE 1.34 mg/mL injection, solutionsyringe of 3 mLA-S Medication Solutions
00169-1715-30SEMAGLUTIDE 1.5 mg/1 tabletbottle of 30 tabletsNovo Nordisk Pharmaceutical Industries, LP
00169-1715-90SEMAGLUTIDE 1.5 mg/1 tabletbottle of 30 tabletsNovo Nordisk Pharmaceutical Industries, LP
00169-4772-12SEMAGLUTIDE 2.68 mg/mL injection, solutionsyringe of 3 mLNovo Nordisk Pharmaceutical Industries, LP
00169-4772-12SEMAGLUTIDE 2.68 mg/mL injection, solutionsyringe of 3 mLNovo Nordisk Pharmaceutical Industries, LP
00169-4772-97SEMAGLUTIDE 2.68 mg/mL injection, solutionsyringe of 3 mLNovo Nordisk Pharmaceutical Industries, LP
00169-4772-97SEMAGLUTIDE 2.68 mg/mL injection, solutionsyringe of 3 mLNovo Nordisk Pharmaceutical Industries, LP
50090-6051-00SEMAGLUTIDE 2.68 mg/mL injection, solutionsyringe of 3 mLA-S Medication Solutions
50090-6051-00SEMAGLUTIDE 2.68 mg/mL injection, solutionsyringe of 3 mLA-S Medication Solutions
00169-1704-30SEMAGLUTIDE 4 mg/1 tabletbottle of 30 tabletsNovo Nordisk Pharmaceutical Industries, LP
00169-1709-30SEMAGLUTIDE 9 mg/1 tabletbottle of 30 tabletsNovo Nordisk Pharmaceutical Industries, LP

Source: the FDA NDC Directory, current listings only. Only packages sold under Ozempic’s own FDA approval (NDA 209637, NDA 213051) are listed, never a generic. Some codes belong to companies that repackage Ozempic: it is the same medicine in a different package.

What a Generic Ozempic Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Ozempic as usual. When one arrives, there is nothing you need to sign up for.

Your Pharmacy May Switch You Automatically

Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.

It Will Probably Look Different

US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.

Your Insurance May Change Too

Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.

Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Ozempic”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.

Questions people ask about Ozempic

Is there a generic for Ozempic right now?

No. As of October 9, 2026 no generic semaglutide is listed for sale in the FDA NDC Directory.

When will Ozempic go generic?

2031 to 2032 is the expected window, and that is likely but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to February 2041; a court ruling or a settlement can bring a generic sooner.

Will generic semaglutide be the same as Ozempic?

Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.

How much will the generic cost?

Nobody can say for sure before launch. 4 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $331.90 pharmacies pay per mL for Ozempic today to about $89.61. That is a pattern from past launches, not a prediction for this one.

Has the FDA approved a generic Ozempic?

Not yet. The FDA Orange Book lists no approved generic version of Ozempic.

When does the Ozempic patent expire?

The FDA Orange Book lists 37 patents for Ozempic; the last runs to February 2041. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (2031 to 2032) weighs all of that.

Has anyone challenged the Ozempic patents?

Yes. The first patent challenge to Ozempic reached the FDA in December 2021, from 7 companies on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.

How much does Ozempic cost now?

Pharmacies paid about $331.90 per mL for Ozempic 1 mg/dose (4 mg/3 mL) pen in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.

Changes to This Projection

  • First generic expected 2031 to 2032 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.

Every change to the expected month is logged here with the month we saw it.

Also Going Generic

All upcoming generics

About Ozempic

  • Generic name semaglutide
  • How it is taken Injection under the skin
  • Company Novo Nordisk Inc
  • Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
  • Patent challenges Since December 2021 (FDA)
  • More drugs Brand-name drugs starting with O
  • Have a question? A pharmacist answers, free. Ask about Ozempic

Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.