Generic competition · all medicines · read 12 November 2026

Is there a generic of Buprenorphine, and who makes it?

Buprenorphine appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came 8.4 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.

Buprenorphine2 dosage-form groups in the Orange Book

4generic makers listed

Buprenorphine appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 generic makers listed as marketed across them.
1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
Where both are dated, the first generic approval came 8.4 years after the first brand approval.
Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Film, Extended Release, Transdermal

Four or more generic makers listed

Brand listed as marketed: Butrans. 4 generic makers with 19 generic products listed as marketed; the first generic approval is dated 20 November 2018.

generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Generic maker (applicant)	First approval	Products
Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc	20 November 2018	5
Amneal Pharmaceuticals Llc	14 April 2020	5
Difgen Pharmaceuticals Llc	23 September 2021	5
Strides Pharma International Ag	17 May 2022	4

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution, Extended Release, Subcutaneous

Brand listed, no generic listed as marketed

Brand listed as marketed: Brixadi and Sublocade. No generic is listed as marketed.

generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

21 February 2028Exclusivity M-314 Sublocade
10 January 2027Patent 8236292 drug product
6 June 2031Patent 9827241 drug product
6 June 2031Patent 9782402 drug product
6 June 2031Patent 9272044
6 June 2031Patent 10198218
6 June 2031Patent 9498432 drug product
6 June 2031Patent 10592168
25 June 2031Patent 10558394 drug product

12 more patents are listed.

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.