When do GLP-1 patents expire? Semaglutide 2031, tirzepatide 2036

Short answer

The key US patent on semaglutide is US Patent 8,129,343, as listed in the FDA Orange Book, and it expires December 5, 2031. The key US patent on tirzepatide is US Patent 9,474,780, as listed in the FDA Orange Book, and it expires May 13, 2036.

Those are two dates on two patents. Neither one is a date on which a generic is guaranteed to appear.

The two dates, side by side

Read from the FDA Orange Book listing, and set out here without any other figure beside them.

Semaglutide — US Patent 8,129,343

expires December 5, 2031

Tirzepatide — US Patent 9,474,780

expires May 13, 2036

Semaglutide: US Patent 8,129,343

The key US patent on semaglutide, US Patent 8,129,343 as listed in the FDA Orange Book, expires on December 5, 2031. The date is the one the Orange Book listing carries for that patent, and the patent number is the one to look up if you want to read the listing yourself.

Tirzepatide: US Patent 9,474,780

The key US patent on tirzepatide, US Patent 9,474,780 as listed in the FDA Orange Book, expires on May 13, 2036. It is a later date than the semaglutide patent, and the two should not be read as one schedule: each patent has its own number, its own listing and its own expiry.

A patent expiry is not a launch date

A patent expiry date is not a guaranteed generic launch date. Other patents, litigation and settlements can move when a generic or a follow-on product actually reaches the market. An expiry date on one patent therefore tells you when that patent runs out; it does not tell you when a product will be available, and it does not tell you what it will cost.

A launch can arrive later than the date printed against a patent, and the reasons lie outside the patent record itself. Treat the two dates above as the dates they are, and not as an arrival schedule.

No generic version is approved today

No generic version of either medication is FDA-approved today. That is true of semaglutide and of tirzepatide. A patent date in the future does not change the present approval record, and nothing on this page should be read as an announcement that a generic exists.

Compounded is not generic

Compounded semaglutide and compounded tirzepatide are not FDA-approved and are not generics. The two terms describe different things. A generic is an approved product that follows a reference drug whose approval it relies on; a compounded preparation is a copy made by a compounding pharmacy, and it is not made under that approval.

Why this guide tracks cash prices

This guide is a dated record of what programs charge in cash for the compounded medications sold today. A patent date is noted as a patent date; it is never used here as a price, a forecast, or evidence that a cheaper product is coming. To see the programs themselves, start with the buyer guide; to see how each charge is read, dated and compared, read how we compare.