FDA — authorised 21 November 2017
- Application: ANDA202118
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: DARUNAVIR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Arm 2 boosted protease inhibitors and maraviroc in United States
FDA authorised Arm 2 boosted protease inhibitors and maraviroc on 21 November 2017
Marketing authorisations
FDA — authorised 7 February 2022
- Application: ANDA203347
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: MARAVIROC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 2023
- Application: ANDA210677
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DARUNAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 2023
- Application: ANDA206288
- Marketing authorisation holder: CIPLA
- Local brand name: DARUNAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 2023
- Application: ANDA212493
- Marketing authorisation holder: AMNEAL
- Local brand name: DARUNAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 2023
- Application: ANDA214085
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DARUNAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 January 2025
- Application: ANDA216168
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: DARUNAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 2025
- Application: ANDA217880
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: MARAVIROC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 2025
- Application: ANDA202136
- Marketing authorisation holder: MYLAN
- Local brand name: DARUNAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 2025
- Application: ANDA216143
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: MARAVIROC
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA207189
- Marketing authorisation holder: CIPLA LTD
- Local brand name: DARUNAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Arm 2 boosted protease inhibitors and maraviroc 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 Arm 2 boosted protease inhibitors and maraviroc approved in United States?
Yes. FDA authorised it on 21 November 2017; FDA authorised it on 7 February 2022; FDA authorised it on 28 November 2023.
Who is the marketing authorisation holder for Arm 2 boosted protease inhibitors and maraviroc in United States?
TEVA PHARMS USA holds the US marketing authorisation.