Zepbound Generic: When Will Generic Tirzepatide Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Zepbound Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January 2040 About 13.5 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? July 2039 8 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic tirzepatide is expected to be available in January 2040, about 13.5 years away. None is for sale yet.
Why January 2040?
It is when Zepbound’s patents 12,343,382, 12,453,758 and 12,616,740 end. They cover a way of using it, and once they end, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
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. 11 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $526.20 pharmacies pay per mL for Zepbound today to under $26.31. See the price estimate
What should I do now?
Keep taking Zepbound 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
Our month is only an estimate based on available information, so we never name a day.
Zepbound by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Very strong 11 companies have filed, 11 first in line
- Brand sales
- $26.8B a yearBlockbuster
- FDA approved 2024 March 2024 FDA Orange Book
- Patents listed 8 last runs to July 2039 FDA Orange Book
- Pharmacies pay $526.20 per mL, up 3.5% in a year NADAC, October 2026
- Medicare Part D spent $1B in 2025, for 160.3K people CMS Part D Spending by Drug
- Medicaid prescriptions 1.8M in the last four reported quarters, $1.9B CMS Medicaid drug utilization, to Q1 2026
Zepbound’s Road to a Generic
Zepbound has had the market to itself since the FDA approved it in March 2024 (Eli Lilly And Co). Its FDA protection (new use) runs to December 2027. Its 8 listed patents run to July 2039. Generic companies have challenged its patents with the FDA since May 2026.
The first generic of Zepbound is expected in January 2040.
Why that month: patents 12,343,382, 12,453,758 and 12,616,740, on a way of using it, end then.
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.
Zepbound Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Zepbound’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.
The one that matters for a generic launch: patents 12,343,382, 12,453,758 and 12,616,740, which end in July 2039; the first generic is expected after it, in January 2040, about 13.5 years away.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,474,780 | The active ingredient; the product’s formulation | May 2036 | Active |
| 11,357,820 | The product’s formulation | June 2039 | Active |
| 11,918,623 | A way of using it (U-3855) | June 2039 | Active |
| 12,453,756 | The product’s formulation | June 2039 | Active |
| 12,629,404 | The product’s formulation; a way of using it (U-4531, U-4532) | June 2039 | Active |
| 12,343,382 Sets the expected month of generic availability | A way of using it (U-4409, U-4228, U-4227, U-4410) | July 2039 | Active |
| 12,453,758 Sets the expected month of generic availability | A way of using it (U-4310, U-4309, U-4308, U-4311) | July 2039 | Active |
| 12,616,740 Sets the expected month of generic availability | A way of using it (U-4497, U-4498, U-4499) | July 2039 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | November 2026 | Active |
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | May 2027 | Active |
| New clinical information M-82 | Three years of protection for a change backed by new clinical studies. | October 2027 | Active |
| New use I-958 | Three years of protection for a newly approved use (indication). | December 2027 | Active |
Source: FDA Orange Book, application 217806. Patent numbers open the patent on Google Patents.
Patent Challenges to Zepbound
The first patent challenge to Zepbound reached the FDA in May 2026, from 11 companies on that first day. The FDA’s list has 9 entries for Zepbound, 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 Zepbound’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.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Subcutaneous solution, 10 mg/0.5 mL 12.5 mg/0.5 mL 15 mg/0.5 mL | May 2026 | 11 companies | No decision yet | Not yet | Not yet | July 2039 |
| Subcutaneous solution, 12.5 mg/0.5 mL | May 2026 | 1 company | No decision yet | Not yet | Not yet | July 2039 |
| Subcutaneous solution, 2.5 mg/0.5 mL 5 mg/0.5 mL | May 2026 | 3 companies | No decision yet | Not yet | Not yet | July 2039 |
| Subcutaneous solution, 2.5 mg/0.5 mL 5 mg/0.5 mL | May 2026 | 12 companies | No decision yet | Not yet | Not yet | July 2039 |
| Subcutaneous solution, 7.5 mg/0.5 mL | May 2026 | 12 companies | No decision yet | Not yet | Not yet | July 2039 |
| Subcutaneous solution, 7.5 mg/0.5 mL 10 mg/0.5 mL 15 mg/0.5 mL | May 2026 | 2 companies | No decision yet | Not yet | Not yet | July 2039 |
| Subcutaneous solution, 10 mg/2.4 mL and 60 mg/2.4 mL | June 2026 | 1 company | No decision yet | Not yet | Not yet | July 2039 |
| Subcutaneous solution, 20 mg/2.4 mL and 30 mg/2.4 mL | August 2026 | 1 company | No decision yet | Not yet | Not yet | July 2039 |
| Subcutaneous solution, 40 mg/2.4 mL and 50 mg/2.4 mL | August 2026 | 1 company | No decision yet | Not yet | Not yet | July 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 Tirzepatide
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.
Applied to the FDA
11 companies have applied to the FDA to make generic tirzepatide.
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. 11 of them were first in line, all 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 Zepbound’s patents with the FDA since May 2026: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic tirzepatide. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic tirzepatide 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).
Zepbound Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Zepbound 2.5 mg/0.5 mL pen
$526.20 per mL in October 2026, up 3.5% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Zepbound 2.5 mg/0.5 mL pen $526.20 per mL
- Zepbound 5 mg/0.5 mL pen $526.08 per mL
- Zepbound 7.5 mg/0.5 mL pen $526.00 per mL
- Zepbound 10 mg/0.5 mL pen $526.05 per mL
- Zepbound 12.5 mg/0.5 mL pen $525.85 per mL
- Zepbound 15 mg/0.5 mL pen $525.92 per mL
See the numbers
| Month | Pharmacies paid per mL |
|---|---|
| October 2026 | $526.20 |
| September 2026 | $526.20 |
| August 2026 | $526.11 |
| July 2026 | $526.28 |
| June 2026 | $525.95 |
| May 2026 | $526.31 |
| April 2026 | $526.31 |
| March 2026 | $526.49 |
| February 2026 | $542.28 |
| January 2026 | $526.07 |
| February 2024 | $508.28 |
| January 2024 | $508.28 |
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
How we estimate it. We start from what pharmacies pay for Zepbound today: $526.20 per mL for Zepbound 2.5 mg/0.5 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). Zepbound has 11 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $526.20 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 Zepbound
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 Zepbound, before manufacturer rebates.
- $494.1M
- January to March 2026, the latest CMS has posted
For 180,140 people, about $1,125 per prescription fill - $1B
- 2025, the whole year
For 160,298 people, about $1,147 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $494,091,986 | 180,140 | $1,124.51 |
| 2025 | $1,035,655,326 | 160,298 | $1,146.90 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Zepbound only, so no generic is counted in it. What CMS says it is used for: This medication is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems (including sleep apnea).
Medicaid Prescriptions by Quarter
1,773,364 prescriptions in the four quarters to Q1 2026, $1.9B paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 297,609 | $312,404,319 |
| Q4 2025 | 603,833 | $635,441,160 |
| Q3 2025 | 531,332 | $558,582,944 |
| Q2 2025 | 340,590 | $355,787,992 |
| Q1 2025 | 241,030 | $250,716,515 |
Source: CMS Medicaid State Drug Utilization Data, over Zepbound’s own package codes.
Zepbound Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 10MG/0.5ML (10MG/0.5ML) | Solution | Subcutaneous | March 2024 | Prescription reference product |
| 12.5MG/0.5ML (12.5MG/0.5ML) | Solution | Subcutaneous | March 2024 | Prescription reference product |
| 15MG/0.5ML (15MG/0.5ML) | Solution | Subcutaneous | March 2024 | Prescription reference product |
| 2.5MG/0.5ML (2.5MG/0.5ML) | Solution | Subcutaneous | March 2024 | Prescription reference product |
| 5MG/0.5ML (5MG/0.5ML) | Solution | Subcutaneous | March 2024 | Prescription reference product |
| 7.5MG/0.5ML (7.5MG/0.5ML) | Solution | Subcutaneous | March 2024 | Prescription reference product |
| 10MG/2.4ML (4.17MG/ML) | Solution | Subcutaneous | January 2026 | Prescription reference product |
| 20MG/2.4ML (8.33MG/ML) | Solution | Subcutaneous | January 2026 | Prescription reference product |
| 30MG/2.4ML (12.5MG/ML) | Solution | Subcutaneous | January 2026 | Prescription reference product |
| 40MG/2.4ML (16.7MG/ML) | Solution | Subcutaneous | January 2026 | Prescription reference product |
| 50MG/2.4ML (20.8MG/ML) | Solution | Subcutaneous | January 2026 | Prescription reference product |
| 60MG/2.4ML (25MG/ML) | Solution | Subcutaneous | January 2026 | Prescription reference product |
Source: FDA Orange Book, Eli Lilly And Co. Listed for sale today by Eli Lilly and Company (FDA NDC Directory).
Zepbound NDC Codes and Packages
Each Zepbound 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.
| NDC | Product | Package | Company |
|---|---|---|---|
| 00002-1340-01 | TIRZEPATIDE 10 mg/.5mL injection, solution | vial of .5 mL | Eli Lilly and Company |
| 00002-1340-04 | TIRZEPATIDE 10 mg/.5mL injection, solution | carton of 4 vials of .5 mL | Eli Lilly and Company |
| 00002-2471-80 | TIRZEPATIDE 10 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-2471-80 | TIRZEPATIDE 10 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-1423-01 | TIRZEPATIDE 12.5 mg/.5mL injection, solution | vial of .5 mL | Eli Lilly and Company |
| 00002-1423-04 | TIRZEPATIDE 12.5 mg/.5mL injection, solution | carton of 4 vials of .5 mL | Eli Lilly and Company |
| 00002-2460-80 | TIRZEPATIDE 12.5 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-2460-80 | TIRZEPATIDE 12.5 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
Show the other 25 Zepbound packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 00002-6210-11 | TIRZEPATIDE 12.5 mg/mL injection, solution | vial of 2.4 mL | Eli Lilly and Company |
| 00002-2002-01 | TIRZEPATIDE 15 mg/.5mL injection, solution | vial of .5 mL | Eli Lilly and Company |
| 00002-2002-04 | TIRZEPATIDE 15 mg/.5mL injection, solution | carton of 4 vials of .5 mL | Eli Lilly and Company |
| 00002-2457-80 | TIRZEPATIDE 15 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-2457-80 | TIRZEPATIDE 15 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-6304-11 | TIRZEPATIDE 16.7 mg/mL injection, solution | vial of 2.4 mL | Eli Lilly and Company |
| 00002-0152-01 | TIRZEPATIDE 2.5 mg/.5mL injection, solution | vial of .5 mL | Eli Lilly and Company |
| 00002-0152-04 | TIRZEPATIDE 2.5 mg/.5mL injection, solution | carton of 4 vials of .5 mL | Eli Lilly and Company |
| 00002-0152-61 | TIRZEPATIDE 2.5 mg/.5mL injection, solution | carton of 4 vials of .5 mL | Eli Lilly and Company |
| 00002-2506-61 | TIRZEPATIDE 2.5 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-2506-61 | TIRZEPATIDE 2.5 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-2506-80 | TIRZEPATIDE 2.5 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-2506-80 | TIRZEPATIDE 2.5 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-6523-11 | TIRZEPATIDE 20.8 mg/mL injection, solution | vial of 2.4 mL | Eli Lilly and Company |
| 00002-6612-11 | TIRZEPATIDE 25 mg/mL injection, solution | vial of 2.4 mL | Eli Lilly and Company |
| 00002-6052-11 | TIRZEPATIDE 4.17 mg/mL injection, solution | vial of 2.4 mL | Eli Lilly and Company |
| 00002-0243-01 | TIRZEPATIDE 5 mg/.5mL injection, solution | vial of .5 mL | Eli Lilly and Company |
| 00002-0243-04 | TIRZEPATIDE 5 mg/.5mL injection, solution | carton of 4 vials of .5 mL | Eli Lilly and Company |
| 00002-2495-80 | TIRZEPATIDE 5 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-2495-80 | TIRZEPATIDE 5 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-1214-01 | TIRZEPATIDE 7.5 mg/.5mL injection, solution | vial of .5 mL | Eli Lilly and Company |
| 00002-1214-04 | TIRZEPATIDE 7.5 mg/.5mL injection, solution | carton of 4 vials of .5 mL | Eli Lilly and Company |
| 00002-2484-80 | TIRZEPATIDE 7.5 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-2484-80 | TIRZEPATIDE 7.5 mg/.5mL injection, solution | carton of 4 syringes of .5 mL | Eli Lilly and Company |
| 00002-6103-11 | TIRZEPATIDE 8.33 mg/mL injection, solution | vial of 2.4 mL | Eli Lilly and Company |
Source: the FDA NDC Directory, current listings only. Only packages sold under Zepbound’s own FDA approval (NDA 217806) are listed, never a generic. Some codes belong to companies that repackage Zepbound: it is the same medicine in a different package.
What a Generic Zepbound Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Zepbound 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 Zepbound”. 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 Zepbound
Is there a generic for Zepbound right now?
No. As of October 9, 2026 no generic tirzepatide is listed for sale in the FDA NDC Directory.
When will Zepbound go generic?
January 2040 is the expected month, and that is probable but not certain. It is when Zepbound’s patents 12,343,382, 12,453,758 and 12,616,740 end. They cover a way of using it, and once they end, generics can go on sale as soon as the FDA approves them.
Will generic tirzepatide be the same as Zepbound?
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. 11 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $526.20 pharmacies pay per mL for Zepbound today to under $26.31. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Zepbound?
Not yet. The FDA Orange Book lists no approved generic version of Zepbound.
When does the Zepbound patent expire?
The FDA Orange Book lists 8 patents for Zepbound; the last runs to July 2039. The one behind the expected month is patents 12,343,382, 12,453,758 and 12,616,740, which end in July 2039. 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 month on this page (January 2040) weighs all of that.
Has anyone challenged the Zepbound patents?
Yes. The first patent challenge to Zepbound reached the FDA in May 2026, from 11 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 Zepbound cost now?
Pharmacies paid about $526.20 per mL for Zepbound 2.5 mg/0.5 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 January 2040 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
- JelmytoMitomycin2029 to 2030
- OnapgoApomorphine HydrochlorideFebruary 2032
- SohonosPalovaroteneAugust 2037
- VoydeyaDanicopanAugust 2038
- EluciremGadopiclenolJanuary 2040
- ArbliLosartan PotassiumOctober 2041
About Zepbound
- Generic name tirzepatide
- How it is taken Injection under the skin
- Company Eli Lilly And Co
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since May 2026 (FDA)
- More drugs Brand-name drugs starting with Z
- Have a question? A pharmacist answers, free. Ask about Zepbound
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.