FDA — authorised 8 May 1998
- Application: ANDA074918
- Marketing authorisation holder: BARR
- Local brand name: NALTREXONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Buprenorphine transdermal patch in United States
FDA authorised Buprenorphine transdermal patch on 8 May 1998 · 11,812 US adverse-event reports
Marketing authorisations
FDA — authorised 26 May 1999
- Application: ANDA075274
- Marketing authorisation holder: ELITE LABS
- Local brand name: NALTREXONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2002
- Application: ANDA076264
- Marketing authorisation holder: SPECGX LLC
- Local brand name: NALTREXONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 August 2011
- Application: ANDA091205
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: NALTREXONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2012
- Application: ANDA090356
- Marketing authorisation holder: SUN PHARM
- Local brand name: NALTREXONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 2016
- Application: NDA207621
- Marketing authorisation holder: PFIZER
- Local brand name: TROXYCA ER
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA207905
- Marketing authorisation holder: CHARTWELL
- Local brand name: NALTREXONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA208043
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: NALTREXONE HYDROCHLORIDE; BUPROPION HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- 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: 11,812
Most-reported reactions
- Drug Dependence — 4,646 reports (39.33%)
- Overdose — 2,242 reports (18.98%)
- Pain — 919 reports (7.78%)
- Emotional Distress — 840 reports (7.11%)
- Foetal Exposure During Pregnancy — 571 reports (4.83%)
- Drug Withdrawal Syndrome Neonatal — 565 reports (4.78%)
- Learning Disability — 565 reports (4.78%)
- Developmental Delay — 537 reports (4.55%)
- Anxiety — 486 reports (4.11%)
- Drug Withdrawal Syndrome — 441 reports (3.73%)
Buprenorphine transdermal patch 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 transdermal patch approved in United States?
Yes. FDA authorised it on 8 May 1998; FDA authorised it on 26 May 1999; FDA authorised it on 22 March 2002.
Who is the marketing authorisation holder for Buprenorphine transdermal patch in United States?
BARR holds the US marketing authorisation.