FDA Orange Book
Generic for Brilinta
Brilinta contains ticagrelor. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Brilinta is ticagrelor. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Brilinta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 60MG | Marketed (Rx) | AB | 17 | AB |
| tablet, oral | 90MG | Marketed (Rx) | AB | 19 | AB |
NDA 022433, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ticagrelor
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 208390 | AB (A-rated, therapeutically equivalent) | September 4, 2018 | 60MG, 90MG |
| HISUN PHARMACEUTICAL HANGZHOU CO LTD | 208575 | AB (A-rated, therapeutically equivalent) | January 23, 2019 | 90MG |
| MYLAN PHARMACEUTICALS INC | 208597 | AB (A-rated, therapeutically equivalent) | July 9, 2021 | 60MG, 90MG |
| ALKEM LABORATORIES LTD | 208567 | AB (A-rated, therapeutically equivalent) | April 21, 2023 | 90MG |
| PRINSTON PHARMACEUTICAL INC | 208599 | AB (A-rated, therapeutically equivalent) | August 16, 2024 | 90MG |
| ALEMBIC PHARMACEUTICALS LTD | 208576 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 60MG, 90MG |
| ALKEM LABORATORIES LTD | 210219 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 60MG |
| APOTEX INC | 208584 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 60MG, 90MG |
| CHANGZHOU PHARMACEUTICAL FACTORY | 216187 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 60MG, 90MG |
| DR REDDYS LABORATORIES LTD | 208541 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 60MG, 90MG |
| INVAGEN PHARMACEUTICALS INC | 208537 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 60MG, 90MG |
| MACLEODS PHARMACEUTICALS LTD | 212258 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 60MG, 90MG |
| MSN LABORATORIES PRIVATE LTD | 208596 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 60MG, 90MG |
| SCIEGEN PHARMACEUTICALS INC | 218962 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 60MG, 90MG |
| SUNSHINE LAKE PHARMA CO LTD | 208508 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 60MG, 90MG |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 211498 | AB (A-rated, therapeutically equivalent) | October 28, 2025 | 60MG, 90MG |
| MANKIND PHARMA LTD | 217679 | AB (A-rated, therapeutically equivalent) | February 6, 2026 | 60MG, 90MG |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO LTD | 219006 | AB (A-rated, therapeutically equivalent) | March 24, 2026 | 60MG, 90MG |
| MICRO LABS LTD | 208539 | AB (A-rated, therapeutically equivalent) | April 27, 2026 | 60MG, 90MG |
| PHARMOBEDIENT CONSULTING LLC | 218869 | AB (A-rated, therapeutically equivalent) | August 20, 2026 | 60MG, 90MG |
Brilinta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8425934 | April 17, 2030 | Drug product | None | 022433 |
| 8425934*PED | October 17, 2030 | Method of use | None | 022433 |
| 10300065 | January 27, 2036 | Method of use | U-2541 | 022433 |
| 10300065 | January 27, 2036 | Method of use | U-2542 | 022433 |
| 10300065*PED | July 27, 2036 | Method of use | None | 022433 |
Brilinta NDC codes
Questions
Is there a generic for Brilinta?
Yes. The generic name for Brilinta is ticagrelor. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Brilinta?
The active ingredient in Brilinta is ticagrelor, per the FDA Orange Book.
When does the Brilinta patent expire?
The last patent listed for Brilinta in the Orange Book expires July 27, 2036. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.