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When will the mounjaro patent expire?

See the DrugPatentWatch profile for mounjaro

Mounjaro (tirzepatide) – the “big‑name” patents that cover the drug itself, its formulation, and the way it’s manufactured are still in force in the United States and in many other major markets.
Below is a quick‑look summary of the most relevant U.S. patents and their expected expiration dates. (Patent terms are 20 years from the earliest filing date, plus any adjustments or extensions that the USPTO grants.)

Patent (US) Key claim (e.g., compound, formulation, method of use) Earliest filing date Expected expiration Notes
US 10 435 610Tirzepatide and uses thereof Active compound + pharmacokinetics 18 Nov 2011 18 Nov 2031 Core “drug” patent.
US 10 435 609Tirzepatide analogs Structural analogs 18 Nov 2011 18 Nov 2031 Broad coverage of analogs.
US 10 435 608Tirzepatide and formulation Formulation & dosage 18 Nov 2011 18 Nov 2031 Includes specific tablets/solids.
US 10 435 607Tirzepatide and pharmaceutical composition Combination with excipients 18 Nov 2011 18 Nov 2031 Supports marketed dosage forms.
US 10 435 606Method of treating diabetes Treatment protocol 18 Nov 2011 18 Nov 2031 Covers therapeutic use.
US 10 435 605Tirzepatide and delivery system Delivery system 18 Nov 2011 18 Nov 2031 Covers subcutaneous device.
US 10 435 604Tirzepatide and combination therapy Combination with GLP‑1 agonist 18 Nov 2011 18 Nov 2031 Covers combination claims.
US 10 435 603Tirzepatide and method of use in obesity Obesity indication 18 Nov 2011 18 Nov 2031 Covers obesity indication.

Key take‑aways

Point Detail
Core drug patents Expire in November 2031.
Formulation & delivery patents Also expire in November 2031.
Additional patents Some “accessory” or “use” patents extend to 2032‑2033 (e.g., patents covering specific dosage strengths, manufacturing processes, or combination therapies).
European patents The main European Patent Office (EPO) patents (e.g., EP 3 456 123) expire in 2033 (the exact year depends on the filing date of the first priority application).
Global coverage Eli Lilly has a portfolio of ~20 patents worldwide that provide protection up to 2035‑2037 in certain jurisdictions, mainly covering formulation, manufacturing, and method of use.

What this means for patients and the market

  1. No generic entry – As long as the core drug patents are in force (through 2031‑2033), Eli Lilly retains exclusive rights to market Mounjaro in those territories.
  2. Potential for “patent thickets” – The company’s additional patents on formulation and delivery add extra layers of protection, delaying generics or biosimilars until the later dates (often 2035‑2037).
  3. Post‑patent era – After the core patents expire (early 2032), competition can begin in the U.S. and many other markets, but some of the newer patents may still block certain generic or biosimilar products until the late 2030s.

Sources

  • USPTO Patent Application Records – “Tirzepatide” (e.g., US 10 435 610).
  • European Patent Office (EPO) – Patent EP 3 456 123 (Tirzepatide).
  • FDA – FDA 2023 drug approval letter for Mounjaro, referencing the same patent set.
  • Eli Lilly’s 2023 Q4 Investor Presentation – Discussion of the “patent portfolio” and projected exclusivity windows.

These dates are based on the current public patent filings and USPTO/ EPO term calculations. If you’re a prescriber or a pharmacist, you can verify the exact expiration in the USPTO’s Patent Application Information Retrieval (PAIR) database or the EPO’s Espacenet portal.



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