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Last Updated: November 21, 2024

Ticagrelor - Generic Drug Details


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What are the generic sources for ticagrelor and what is the scope of freedom to operate?

Ticagrelor is the generic ingredient in two branded drugs marketed by Astrazeneca, Alkem Labs Ltd, Amneal, Hisun Pharm Hangzhou, Mylan, Prinston Inc, Sigmapharm Labs Llc, Sunshine, and Watson Labs Inc, and is included in nine NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ticagrelor has one hundred and forty-seven patent family members in forty-four countries.

There are twenty-one drug master file entries for ticagrelor. Four suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for ticagrelor
Recent Clinical Trials for ticagrelor

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Zunyi Medical CollegePhase 4
Fu Wai Hospital, Beijing, ChinaPhase 4
Giampiero VizzariPhase 3

See all ticagrelor clinical trials

Generic filers with tentative approvals for TICAGRELOR
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up90MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up90MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up90MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan TICAGRELOR ticagrelor TABLET;ORAL 208597-002 Jul 9, 2021 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

Expired US Patents for ticagrelor

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

International Patents for ticagrelor

Country Patent Number Title Estimated Expiration
Portugal 1386921 ⤷  Sign Up
European Patent Office 3730142 MÉTHODE DE TRAITEMENT OU DE PRÉVENTION D'ÉVÉNEMENTS ATHÉROTHROMBOTIQUES CHEZ DES PATIENTS PRÉSENTANT DES ANTÉCÉDENTS D'INFARCTUS DU MYOCARDE (METHOD OF TREATING OR PREVENTION OF ATHEROTHROMBOTIC EVENTS IN PATIENTS WITH HISTORY OF MYOCARDIAL INFARCTION) ⤷  Sign Up
Austria 261970 ⤷  Sign Up
Poland 348724 ⤷  Sign Up
Japan 2008266345 NOVEL TRIAZOLO(4,5-D)PYRIMIDINE COMPOUND ⤷  Sign Up
Japan 2010501554 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ticagrelor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1135391 SPC/GB11/016 United Kingdom ⤷  Sign Up PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/10/655/001 20101203; UK EU/1/10/655/002 20101203; UK EU/1/10/655/003 20101203; UK EU/1/10/655/004 20101203; UK EU/1/10/655/005 20101203; UK EU/1/10/655/006 20101203
1135391 406 Finland ⤷  Sign Up
1135391 1190009-9 Sweden ⤷  Sign Up PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203
1135391 C01135391/01 Switzerland ⤷  Sign Up FORMER REPRESENTATIVE: BOHEST AG, CH
1135391 CA 2011 00013 Denmark ⤷  Sign Up PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
1135391 PA2011004 Lithuania ⤷  Sign Up PRODUCT NAME: TICAGRELORUM; REGISTRATION NO/DATE: EU/1/10/655/001 2010 12 03 EU/1/10/655/002 2010 12 03 EU/1/10/655/003 2010 12 03 EU/1/10/655/004 2010 12 03 EU/1/10/655/005 2010 12 03 EU/1/10/655/00 20101203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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