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OmniRx › Tools › Generic competition check › Buprenorphine Hydrochloride

Generic competition · all medicines · read 12 November 2026

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

Buprenorphine Hydrochloride appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 11 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 7 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.
Buprenorphine Hydrochloride4 dosage-form groups in the Orange Book
11generic makers listed
  1. Buprenorphine Hydrochloride appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 11 generic makers listed as marketed across them.
  2. 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.
  3. Where both are dated, the first generic approval came 7 years after the first brand approval.
  4. 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.

Tablet, Sublingual

Four or more generic makers listed

Every brand product here is listed as discontinued. 8 generic makers with 18 generic products listed as marketed; the first generic approval is dated 8 October 2009.

200020052010201520202025203008brand 2002Hikma Pharmaceuticals Usa Inc, first approval 8 October 2009Ethypharm Inc, first approval 24 September 2010Actavis Elizabeth Llc, first approval 19 February 2015Rubicon Research Ltd, first approval 10 June 2015Sun Pharmaceutical Industries Ltd, first approval 29 January 2016Rhodes Pharmaceuticals Lp, first approval 27 March 2017Specgx Llc, first approval 10 December 2025Ascent Pharmaceuticals Inc, first approval 18 December 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Hikma Pharmaceuticals Usa Inc8 October 20092
Ethypharm Inc24 September 20102
Actavis Elizabeth Llc19 February 20152
Rubicon Research Ltd10 June 20154
Sun Pharmaceutical Industries Ltd29 January 20162
Rhodes Pharmaceuticals Lp27 March 20172
Specgx Llc10 December 20252
Ascent Pharmaceuticals Inc18 December 20252

Patents and exclusivities still listed

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

Film, Buccal

Brand listed, no generic listed as marketed

Brand listed as marketed: Belbuca. No generic is listed as marketed.

2015202020252030203501brand 2015data datePatent 9655843 listed to expire 23 July 2027Patent 8147866 listed to expire 23 July 2027Patent 9901539 listed to expire 21 December 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 23 July 2027Patent 9655843 drug product
  • 23 July 2027Patent 8147866 drug product
  • 21 December 2032Patent 9901539

Injectable, Injection

Four or more generic makers listed

Every brand product here is listed as discontinued. 4 generic makers with 4 generic products listed as marketed; the first generic approval is dated 3 June 1996.

1995200020052010201520202025203004Hospira Inc, first approval 3 June 1996Hikma Pharmaceuticals Usa Inc, first approval 2 March 2005Ph Health Ltd, first approval 28 July 2015Somerset Therapeutics Llc, first approval 30 January 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Hospira Inc3 June 19961
Hikma Pharmaceuticals Usa Inc2 March 20051
Ph Health Ltd28 July 20151
Somerset Therapeutics Llc30 January 20251

Patents and exclusivities still listed

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

Implant, Implantation

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed.

201520202025203001brand 2016data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

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

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.