Home / Generic availability / Tirzepatide
When will generic Tirzepatide be available?
Based on the patents and exclusivity the FDA lists today, generic tirzepatide cannot be marketed in the United States before 2041-12-30, when the last listed protection expires.
Patents listed with the FDA
40 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 9474780 | 2036-05-13 | drug substance, drug product | MOUNJARO (AUTOINJECTOR) |
| 9474780 | 2036-05-13 | drug substance, drug product | MOUNJARO |
| 9474780 | 2036-05-13 | drug substance, drug product | MOUNJARO KWIKPEN |
| 9474780 | 2036-05-13 | drug substance, drug product | ZEPBOUND (AUTOINJECTOR) |
| 9474780 | 2036-05-13 | drug substance, drug product | ZEPBOUND |
| 9474780 | 2036-05-13 | drug substance, drug product | ZEPBOUND KWIKPEN |
| 11357820 | 2039-06-14 | drug product | MOUNJARO (AUTOINJECTOR) |
| 12453755 | 2039-06-14 | method of use | MOUNJARO (AUTOINJECTOR) |
| 12453756 | 2039-06-14 | drug product | MOUNJARO (AUTOINJECTOR) |
| 12629404 | 2039-06-14 | drug product | MOUNJARO (AUTOINJECTOR) |
| 11357820 | 2039-06-14 | drug substance, drug product | MOUNJARO |
| 12453755 | 2039-06-14 | method of use | MOUNJARO |
| 12453756 | 2039-06-14 | drug product | MOUNJARO |
| 12629404 | 2039-06-14 | drug product | MOUNJARO |
| 11357820 | 2039-06-14 | drug product | ZEPBOUND (AUTOINJECTOR) |
| 11918623 | 2039-06-14 | method of use | ZEPBOUND (AUTOINJECTOR) |
| 12453756 | 2039-06-14 | drug product | ZEPBOUND (AUTOINJECTOR) |
| 12629404 | 2039-06-14 | drug product | ZEPBOUND (AUTOINJECTOR) |
| 11357820 | 2039-06-14 | drug product | ZEPBOUND |
| 11918623 | 2039-06-14 | method of use | ZEPBOUND |
| 12453756 | 2039-06-14 | drug product | ZEPBOUND |
| 12629404 | 2039-06-14 | drug product | ZEPBOUND |
| 12343382 | 2039-07-22 | method of use | MOUNJARO (AUTOINJECTOR) |
| 12616740 | 2039-07-22 | method of use | MOUNJARO (AUTOINJECTOR) |
| 12343382 | 2039-07-22 | method of use | MOUNJARO |
| 12616740 | 2039-07-22 | method of use | MOUNJARO |
| 12343382 | 2039-07-22 | method of use | MOUNJARO KWIKPEN |
| 12616740 | 2039-07-22 | method of use | MOUNJARO KWIKPEN |
| 12343382 | 2039-07-22 | method of use | ZEPBOUND (AUTOINJECTOR) |
| 12453758 | 2039-07-22 | method of use | ZEPBOUND (AUTOINJECTOR) |
| 12616740 | 2039-07-22 | method of use | ZEPBOUND (AUTOINJECTOR) |
| 12343382 | 2039-07-22 | method of use | ZEPBOUND |
| 12453758 | 2039-07-22 | method of use | ZEPBOUND |
| 12616740 | 2039-07-22 | method of use | ZEPBOUND |
| 12343382 | 2039-07-22 | method of use | ZEPBOUND KWIKPEN |
| 12453758 | 2039-07-22 | method of use | ZEPBOUND KWIKPEN |
| 12616740 | 2039-07-22 | method of use | ZEPBOUND KWIKPEN |
| 12295987 | 2041-12-30 | method of use | MOUNJARO (AUTOINJECTOR) |
| 12295987 | 2041-12-30 | method of use | MOUNJARO |
| 12295987 | 2041-12-30 | method of use | MOUNJARO KWIKPEN |
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| NP | 2026-11-08 | New product | ZEPBOUND (AUTOINJECTOR) |
| NCE | 2027-05-13 | New chemical entity (5 years) | MOUNJARO (AUTOINJECTOR) |
| NCE | 2027-05-13 | New chemical entity (5 years) | MOUNJARO |
| NCE | 2027-05-13 | New chemical entity (5 years) | MOUNJARO KWIKPEN |
| NCE | 2027-05-13 | New chemical entity (5 years) | ZEPBOUND (AUTOINJECTOR) |
| NCE | 2027-05-13 | New chemical entity (5 years) | ZEPBOUND |
| NCE | 2027-05-13 | New chemical entity (5 years) | ZEPBOUND KWIKPEN |
| M-82 | 2027-10-18 | Exclusivity tied to a specific labelling or study change | ZEPBOUND (AUTOINJECTOR) |
| M-82 | 2027-10-18 | Exclusivity tied to a specific labelling or study change | ZEPBOUND |
| M-82 | 2027-10-18 | Exclusivity tied to a specific labelling or study change | ZEPBOUND KWIKPEN |
| I-958 | 2027-12-20 | New indication (3 years) | ZEPBOUND (AUTOINJECTOR) |
| I-958 | 2027-12-20 | New indication (3 years) | ZEPBOUND |
| I-958 | 2027-12-20 | New indication (3 years) | ZEPBOUND KWIKPEN |
| NPP | 2028-12-19 | New patient population | MOUNJARO (AUTOINJECTOR) |
| NPP | 2028-12-19 | New patient population | MOUNJARO |
| NPP | 2028-12-19 | New patient population | MOUNJARO KWIKPEN |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | Brand (NDA) | ELI LILLY AND CO | 2022-05-13 | reference listed drug, reference standard |
| ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | Brand (NDA) | ELI LILLY AND CO | 2023-11-08 | reference listed drug, reference standard |
Frequently asked questions
When will generic Tirzepatide be available?
Based on the patents and exclusivity the FDA lists today, generic tirzepatide cannot be marketed in the United States before 2041-12-30, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-09-23. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.