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Last Updated: November 21, 2024

TICAGRELOR Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Ticagrelor

A generic version of TICAGRELOR was approved as ticagrelor by HISUN PHARM HANGZHOU on January 23rd, 2019.

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Drug patent expirations by year for TICAGRELOR
Recent Clinical Trials for TICAGRELOR

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SponsorPhase
Zunyi Medical CollegePhase 4
Fu Wai Hospital, Beijing, ChinaPhase 4
Giorgio QuadriPhase 3

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Paragraph IV (Patent) Challenges for TICAGRELOR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BRILINTA Tablets ticagrelor 60 mg 022433 3 2015-09-30
BRILINTA Tablets ticagrelor 90 mg 022433 16 2015-07-20

US Patents and Regulatory Information for TICAGRELOR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd TICAGRELOR ticagrelor TABLET;ORAL 208567-001 Apr 21, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sigmapharm Labs Llc TICAGRELOR ticagrelor TABLET;ORAL 208596-001 Apr 7, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan TICAGRELOR ticagrelor TABLET;ORAL 208597-001 Jul 9, 2021 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sunshine TICAGRELOR ticagrelor TABLET;ORAL 208508-001 Apr 6, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for TICAGRELOR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AstraZeneca AB Brilique ticagrelor EMEA/H/C/001241
Brilique, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients withacute coronary syndromes (ACS) ora history of myocardial infarction (MI) and a high risk of developing an atherothrombotic eventBrilique, co-administered with acetyl salicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event.
Authorised no no no 2010-12-03
AstraZeneca AB Possia ticagrelor EMEA/H/C/002303
Possia, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).
Withdrawn no no no 2010-12-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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