FDA Orange Book · active-ingredient family
Ticagrelor
Ticagrelor: 1 brand, 21 generics; first approved Jul 20, 2011; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 21 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
21
Listed patents
4
Next patent expiry
Apr 17, 2030
in 3 yr 7 mo
Brand (NDA) products
Originator applications
- BRILINTARLDASTRAZENECANDA 02243320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB
Generic (ANDA) products (21)
Abbreviated applications
- TICAGRELORLAURUSANDA 21886920262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB - TICAGRELORMICRO LABSANDA 20853920262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB - TICAGRELORZHEJIANG JINGXINANDA 21900620262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB - TICAGRELORMANKIND PHARMAANDA 21767920262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB - TICAGRELORALEMBICANDA 20857620252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB - TICAGRELORALKEM LABS LTDANDA 2102192025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Rx AB - TICAGRELORAMNEALANDA 20853120252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — - TICAGRELORAPOTEXANDA 20858420252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB - TICAGRELORCHANGZHOU PHARMANDA 21618720252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB - TICAGRELORDR REDDYSANDA 20854120252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB - TICAGRELORINVAGEN PHARMSANDA 20853720252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB - TICAGRELORMACLEODS PHARMSANDA 21225820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB - TICAGRELORMSNANDA 20859620252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB - TICAGRELORSCIEGEN PHARMSANDA 21896220252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB - TICAGRELORSUNSHINEANDA 20850820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB - TICAGRELORTAROANDA 21149820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB - TICAGRELORPRINSTON INCANDA 2085992024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB - TICAGRELORALKEM LABS LTDANDA 2085672023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB - TICAGRELORMYLANANDA 20859720212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB - TICAGRELORHISUN PHARM HANGZHOUANDA 2085752019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB - TICAGRELORWATSON LABS INCANDA 20839020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG TABLET ORAL Rx AB 90MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8425934 | in 3 yr 7 mo | Product | |
| 8425934*PED | in 4 yr 2 mo | ||
| 10300065 | in 9 yr 6 mo | U-2541 | |
| 10300065*PED | in 10 yr |
Approval history
FDA approval span
First approval
15 yr 5 mo ago
Most recent approval
1 mo ago
Approvals span 2011–2026 across 22 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 2195%
Ticagrelor: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
