FDA — authorised 26 June 2014
- Application: ANDA077492
- Marketing authorisation holder: OHM LABS INC
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Sacubitril-valsartan in United States
FDA authorised Sacubitril-valsartan on 26 June 2014
Marketing authorisations
FDA — authorised 5 January 2015
- Application: ANDA202728
- Marketing authorisation holder: TORRENT
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2015
- Application: ANDA090642
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2015
- Application: ANDA202223
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2015
- Application: ANDA201677
- Marketing authorisation holder: LUPIN
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2015
- Application: ANDA090866
- Marketing authorisation holder: MYLAN
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 January 2015
- Application: ANDA203311
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 June 2015
- Application: ANDA204821
- Marketing authorisation holder: PRINSTON INC
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2015
- Application: NDA207620
- Marketing authorisation holder: NOVARTIS PHARMS CORP
- Local brand name: ENTRESTO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 January 2016
- Application: ANDA077530
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 2016
- Application: ANDA204011
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 2016
- Application: ANDA202696
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 April 2018
- Application: ANDA205347
- Marketing authorisation holder: SQUARE PHARMS PLC
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 March 2019
- Application: ANDA205536
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 2021
- Application: ANDA201618
- Marketing authorisation holder: DR REDDYS
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2021
- Application: ANDA204038
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 November 2021
- Application: ANDA214102
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: VALSARTAN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 22 July 2024
- Application: ANDA218991
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 August 2024
- Application: ANDA218169
- Marketing authorisation holder: RENATA
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 June 2025
- Application: ANDA216460
- Marketing authorisation holder: RUBICON
- Local brand name: VALSARTAN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 21 April 2026
- Application: ANDA218897
- Marketing authorisation holder: LAURUS
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA205357
- Marketing authorisation holder: HUAREN PHARMACEUTICAL CO LTD
- Local brand name: VALSARTAN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Sacubitril-valsartan 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 Sacubitril-valsartan approved in United States?
Yes. FDA authorised it on 26 June 2014; FDA authorised it on 5 January 2015; FDA authorised it on 5 January 2015.
Who is the marketing authorisation holder for Sacubitril-valsartan in United States?
OHM LABS INC holds the US marketing authorisation.