FDA — authorised 2 March 2005
- Application: ANDA076931
- Marketing authorisation holder: HIKMA
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 BUPRENORPHINE HYDROCHLORIDE in United States
FDA authorised BUPRENORPHINE HYDROCHLORIDE on 2 March 2005 · 7,628 US adverse-event reports
Marketing authorisations
FDA — authorised 27 March 2007
- Application: ANDA078331
- Marketing authorisation holder: AM REGENT
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 October 2009
- Application: ANDA078633
- Marketing authorisation holder: HIKMA
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 7 May 2010
- Application: ANDA090360
- Marketing authorisation holder: BARR
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 24 September 2010
- Application: ANDA090622
- Marketing authorisation holder: ETHYPHARM
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 22 February 2013
- Application: ANDA091422
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 27 June 2014
- Application: ANDA203326
- Marketing authorisation holder: HIKMA
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 8 September 2014
- Application: ANDA091149
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 19 February 2015
- Application: ANDA090819
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 6 March 2015
- Application: ANDA201066
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 10 June 2015
- Application: ANDA090279
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 28 July 2015
- Application: ANDA206586
- Marketing authorisation holder: PH HEALTH
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 October 2015
- Application: ANDA204431
- Marketing authorisation holder: ETHYPHARM
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 29 January 2016
- Application: ANDA201760
- Marketing authorisation holder: SUN PHARM
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 5 August 2016
- Application: ANDA201633
- Marketing authorisation holder: SUN PHARM
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 27 March 2017
- Application: ANDA207276
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 13 December 2017
- Application: ANDA207000
- Marketing authorisation holder: SPECGX LLC
- Status: supplemented
FDA — authorised 14 June 2018
- Application: ANDA205806
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: FILM — BUCCAL, SUBLINGUAL
- Status: approved
FDA — authorised 14 June 2018
- Application: ANDA205299
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: FILM — BUCCAL, SUBLINGUAL
- Status: approved
FDA — authorised 14 June 2018
- Application: ANDA207607
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: FILM — BUCCAL, SUBLINGUAL
- Status: approved
FDA — authorised 7 September 2018
- Application: NDA208042
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: CASSIPA
- Indication: FILM — SUBLINGUAL
- Status: approved
FDA — authorised 24 January 2019
- Application: ANDA205954
- Marketing authorisation holder: ALVOGEN
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: FILM — BUCCAL, SUBLINGUAL
- Status: approved
FDA — authorised 30 March 2020
- Application: ANDA205601
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 17 April 2020
- Application: ANDA211785
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: FILM — BUCCAL, SUBLINGUAL
- Status: approved
FDA — authorised 17 July 2020
- Application: ANDA209069
- Marketing authorisation holder: WES PHARMA INC
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 17 July 2020
- Application: ANDA206953
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 15 June 2021
- Application: ANDA214930
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 2 June 2022
- Application: ANDA212756
- Marketing authorisation holder: DIFGEN PHARMS
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: FILM — BUCCAL, SUBLINGUAL
- Status: approved
FDA — authorised 30 January 2025
- Application: ANDA219302
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 December 2025
- Application: ANDA218473
- Marketing authorisation holder: SPECGX LLC
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 15 December 2025
- Application: ANDA219727
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 18 December 2025
- Application: ANDA219401
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: BUPRENORPHINE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Application: ANDA214737
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Application: ANDA204383
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
- Indication: FILM — BUCCAL, SUBLINGUAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 7,628
Most-reported reactions
- Dependence — 2,282 reports (29.92%)
- Overdose — 1,309 reports (17.16%)
- Drug Dependence — 574 reports (7.52%)
- Pain — 571 reports (7.49%)
- Anxiety — 559 reports (7.33%)
- Foetal Exposure During Pregnancy — 527 reports (6.91%)
- Drug Withdrawal Syndrome Neonatal — 497 reports (6.52%)
- Maternal Exposure During Pregnancy — 492 reports (6.45%)
- Emotional Distress — 434 reports (5.69%)
- Death — 383 reports (5.02%)
BUPRENORPHINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is BUPRENORPHINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 2 March 2005; FDA authorised it on 27 March 2007; FDA authorised it on 8 October 2009.
Who is the marketing authorisation holder for BUPRENORPHINE HYDROCHLORIDE in United States?
HIKMA holds the US marketing authorisation.