FDA — authorised 7 March 2014
- Application: NDA022433
- Marketing authorisation holder: ASTRAZENECA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Brilinta in United States
FDA authorised Brilinta on 7 March 2014
Marketing authorisations
FDA — authorised 4 September 2018
- Application: ANDA208390
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 2019
- Application: ANDA208575
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2020
- Application: ANDA208596
- Marketing authorisation holder: MSN
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 2021
- Application: ANDA208597
- Marketing authorisation holder: MYLAN
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 2023
- Application: ANDA208567
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 August 2024
- Application: ANDA208599
- Marketing authorisation holder: PRINSTON INC
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 2025
- Application: ANDA208508
- Marketing authorisation holder: SUNSHINE
- Indication: Labeling
- Status: approved
The FDA approved Brilinta for its labelled indication on 2025-04-15. The marketing authorisation holder is SUNSHINE. This approval was granted under the standard expedited pathway.
FDA — authorised 1 May 2025
- Application: ANDA208584
- Marketing authorisation holder: APOTEX
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 May 2025
- Application: ANDA208576
- Marketing authorisation holder: ALEMBIC
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2025
- Application: ANDA212258
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
FDA — authorised 28 October 2025
- Application: ANDA216187
- Marketing authorisation holder: CHANGZHOU PHARM
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2025
- Application: ANDA211498
- Marketing authorisation holder: TARO
- Local brand name: TICAGRELOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 2025
- Application: ANDA210219
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
Brilinta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Brilinta approved in United States?
Yes. FDA authorised it on 7 March 2014; FDA authorised it on 4 September 2018; FDA authorised it on 23 January 2019.
Who is the marketing authorisation holder for Brilinta in United States?
ASTRAZENECA holds the US marketing authorisation.