FDA Orange Book · active-ingredient family
Buprenorphine hydrochloride
Buprenorphine hydrochloride: 4 brands, 15 generics; first approved Jun 03, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
15
Listed patents
3
Next patent expiry
Jul 23, 2027
in 1 yr
Brand (NDA) products
Originator applications
- PROBUPHINERLDREACX PHARMSNDA 2044422016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 80MG BASE/IMPLANT IMPLANT IMPLANTATION Discontinued — - BELBUCARLDBDSINDA 20793220157 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.075MG BASE FILM BUCCAL Rx — EQ 0.15MG BASE FILM BUCCAL Rx — EQ 0.3MG BASE FILM BUCCAL Rx — EQ 0.45MG BASE FILM BUCCAL Rx — EQ 0.6MG BASE FILM BUCCAL Rx — EQ 0.75MG BASE FILM BUCCAL Rx — EQ 0.9MG BASE FILM BUCCAL Rx — - SUBUTEXRLDINDIVIORNDA 02073220022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET SUBLINGUAL Discontinued — EQ 8MG BASE TABLET SUBLINGUAL Discontinued — - BUPRENEXRLDINDIVIORNDA 018401—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3MG BASE/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (15)
Abbreviated applications
- BUPRENORPHINE HYDROCHLORIDEASCENT PHARMS INCANDA 21940120252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET SUBLINGUAL Rx AB EQ 8MG BASE TABLET SUBLINGUAL Rx AB - BUPRENORPHINE HYDROCHLORIDESPECGX LLCANDA 21847320252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET SUBLINGUAL Rx AB EQ 8MG BASE TABLET SUBLINGUAL Rx AB - BUPRENORPHINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 2193022025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3MG BASE/ML INJECTABLE INJECTION Rx AP - BUPRENORPHINE HYDROCHLORIDERHODES PHARMSANDA 20727620172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET SUBLINGUAL Rx AB EQ 8MG BASE TABLET SUBLINGUAL Rx AB - BUPRENORPHINE HYDROCHLORIDESUN PHARMANDA 20176020162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET SUBLINGUAL Rx AB EQ 8MG BASE TABLET SUBLINGUAL Rx AB - BUPRENORPHINE HYDROCHLORIDERSPH HEALTHANDA 2065862015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3MG BASE/ML INJECTABLE INJECTION Rx AP - BUPRENORPHINE HYDROCHLORIDERUBICON RESEARCHANDA 09027920152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET SUBLINGUAL Rx AB EQ 8MG BASE TABLET SUBLINGUAL Rx AB - BUPRENORPHINE HYDROCHLORIDEQUAGENANDA 20106620152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET SUBLINGUAL Discontinued — EQ 8MG BASE TABLET SUBLINGUAL Discontinued — - BUPRENORPHINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 09081920152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET SUBLINGUAL Rx AB EQ 8MG BASE TABLET SUBLINGUAL Rx AB - BUPRENORPHINE HYDROCHLORIDEETHYPHARMANDA 09062220102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET SUBLINGUAL Rx AB EQ 8MG BASE TABLET SUBLINGUAL Rx AB - BUPRENORPHINE HYDROCHLORIDEBARRANDA 09036020102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET SUBLINGUAL Discontinued — EQ 8MG BASE TABLET SUBLINGUAL Discontinued — - BUPRENORPHINE HYDROCHLORIDEHIKMAANDA 07863320092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE TABLET SUBLINGUAL Rx AB EQ 8MG BASE TABLET SUBLINGUAL Rx AB - BUPRENORPHINE HYDROCHLORIDEAM REGENTANDA 0783312007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3MG BASE/ML INJECTABLE INJECTION Discontinued — - BUPRENORPHINE HYDROCHLORIDEHIKMAANDA 0769312005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3MG BASE/ML INJECTABLE INJECTION Rx AP - BUPRENORPHINE HYDROCHLORIDEHOSPIRAANDA 0741371996
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3MG BASE/ML INJECTABLE INJECTION Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9655843 | in 1 yr | ProductU-1556 | |
| 8147866 | in 1 yr | ProductU-1769 | |
| 9901539 | in 6 yr 5 mo | U-1556 |
Approval history
FDA approval span
First approval
30 yr 8 mo ago
Most recent approval
8 mo ago
Approvals span 1996–2025 across 19 FDA applications.
Brand (NDA) 421%
Generic (ANDA) 1579%
Buprenorphine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
