Is there a generic for Ticagrelor?

Yes. The FDA Orange Book lists 20 approved generic (ANDA) applications for Ticagrelor, referencing the brand BRILINTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ticagrelor?

BRILINTA (NDA 022433, ASTRAZENECA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Ticagrelor?

The Orange Book lists 4 patents against Ticagrelor products, with the earliest listed expiry in 2030. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Ticagrelor are approved?

Ticagrelor is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Ticagrelor

Ticagrelor is approved as 1 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BRILINTA · NDA 022433

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
BRILINTARLD×2	ASTRAZENECA	NDA 022433	AB	Sep 03, 2015

Generic (ANDA) products (20)

Product	Applicant	Application	TE	Approved
TICAGRELOR×2	MICRO LABS	ANDA 208539	AB	Apr 27, 2026
TICAGRELOR×2	ZHEJIANG JINGXIN	ANDA 219006	AB	Mar 24, 2026
TICAGRELOR×2	MANKIND PHARMA	ANDA 217679	AB	Feb 06, 2026
TICAGRELOR×2	ALEMBIC	ANDA 208576	AB	Oct 28, 2025
TICAGRELOR	ALKEM LABS LTD	ANDA 210219	AB	Oct 28, 2025
TICAGRELOR×2	AMNEAL	ANDA 208531	—	Oct 28, 2025
TICAGRELOR×2	APOTEX	ANDA 208584	AB	Oct 28, 2025
TICAGRELOR×2	CHANGZHOU PHARM	ANDA 216187	AB	Oct 28, 2025
TICAGRELOR×2	DR REDDYS	ANDA 208541	AB	Oct 28, 2025
TICAGRELOR×2	INVAGEN PHARMS	ANDA 208537	AB	Oct 28, 2025
TICAGRELOR×2	MACLEODS PHARMS LTD	ANDA 212258	AB	Oct 28, 2025
TICAGRELOR×2	MSN	ANDA 208596	AB	Oct 28, 2025
TICAGRELOR×2	SCIEGEN PHARMS	ANDA 218962	AB	Oct 28, 2025
TICAGRELOR×2	SUNSHINE	ANDA 208508	AB	Oct 28, 2025
TICAGRELOR×2	TARO	ANDA 211498	AB	Oct 28, 2025
TICAGRELOR	PRINSTON INC	ANDA 208599	AB	Aug 16, 2024
TICAGRELOR	ALKEM LABS LTD	ANDA 208567	AB	Apr 21, 2023
TICAGRELOR×2	MYLAN	ANDA 208597	AB	Jul 09, 2021
TICAGRELOR	HISUN PHARM HANGZHOU	ANDA 208575	AB	Jan 23, 2019
TICAGRELOR×2	WATSON LABS INC	ANDA 208390	AB	Sep 04, 2018

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8425934	Apr 17, 2030	in 3 yr 11 mo	Product
8425934*PED	Oct 17, 2030	in 4 yr 5 mo
10300065	Jan 27, 2036	in 9 yr 9 mo	U-2541
10300065*PED	Jul 27, 2036	in 10 yr 3 mo

Ticagrelor — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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