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Home / Generic availability / Exenatide

FDA Orange Book · updated 2026-09-23

When will generic Exenatide be available?

Under patent or exclusivity

Based on the patents and exclusivity the FDA lists today, generic exenatide cannot be marketed in the United States before 2031-04-04, when the last listed protection expires.

2031-04-04
Last protection expires
38
Patents listed
0
Exclusivity records
0
Generics waiting

Patents listed with the FDA

38 unexpired or current listing(s).

PatentExpiresCoversProduct
65151172025-10-04drug substance, drug productBYDUREON BCISE
65151172025-10-04drug substance, drug productBYDUREON
65151172025-10-04drug substance, drug productBYDUREON PEN
6515117*PED2026-04-04method of useBYDUREON BCISE
6515117*PED2026-04-04method of useBYDUREON
6515117*PED2026-04-04method of useBYDUREON PEN
83296482026-08-18method of useBYDUREON BCISE
89068512026-08-18method of useBYDUREON BCISE
98840922026-08-18method of useBYDUREON BCISE
83296482026-08-18method of useBYDUREON
89068512026-08-18method of useBYDUREON
98840922026-08-18method of useBYDUREON
83296482026-08-18method of useBYDUREON PEN
89068512026-08-18method of useBYDUREON PEN
98840922026-08-18method of useBYDUREON PEN
8329648*PED2027-02-18method of useBYDUREON BCISE
8906851*PED2027-02-18method of useBYDUREON BCISE
9884092*PED2027-02-18method of useBYDUREON BCISE
8329648*PED2027-02-18method of useBYDUREON
8906851*PED2027-02-18method of useBYDUREON
9884092*PED2027-02-18method of useBYDUREON
8329648*PED2027-02-18method of useBYDUREON PEN
8906851*PED2027-02-18method of useBYDUREON PEN
9884092*PED2027-02-18method of useBYDUREON PEN
85016982027-06-20method of useBYDUREON BCISE
85016982027-06-20drug productBYDUREON
85016982027-06-20drug productBYDUREON PEN
8501698*PED2027-12-20method of useBYDUREON BCISE
8501698*PED2027-12-20method of useBYDUREON
8501698*PED2027-12-20method of useBYDUREON PEN
83619722028-03-21method of useBYDUREON BCISE
83619722028-03-21method of useBYDUREON
83619722028-03-21method of useBYDUREON PEN
8361972*PED2028-09-21method of useBYDUREON BCISE
8361972*PED2028-09-21method of useBYDUREON
8361972*PED2028-09-21method of useBYDUREON PEN
88950332030-10-04drug productBYDUREON BCISE
8895033*PED2031-04-04method of useBYDUREON BCISE

Approved products

ProductTypeApplicantApproved
BYETTABrand (NDA)ASTRAZENECA AB2005-04-28reference listed drug
BYDUREON, BYDUREON PENBrand (NDA)ASTRAZENECA AB2012-01-27reference listed drug
EXENATIDE SYNTHETICGeneric (ANDA)AMNEAL EU LTD2024-11-19reference standard
BYDUREON BCISEBrand (NDA)ASTRAZENECA AB2017-10-20reference listed drug
How to read these dates. They come from the FDA Orange Book, which records the patents a brand has listed and the exclusivity the FDA has granted. The date shown is when the last of those expires. It is an upper bound on protection, not a prediction of when a generic will actually reach pharmacies.

Frequently asked questions

When will generic Exenatide be available?

Based on the patents and exclusivity the FDA lists today, generic exenatide cannot be marketed in the United States before 2031-04-04, 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.