Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Dow
McKesson
Express Scripts
Boehringer Ingelheim

Last Updated: November 30, 2022

Ticagrelor - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic drug sources for ticagrelor and what is the scope of patent protection?

Ticagrelor is the generic ingredient in two branded drugs marketed by Astrazeneca, Amneal, Hisun Pharm Hangzhou, Mylan, Sigmapharm Labs Llc, Sunshine, and Watson Labs Inc, and is included in seven 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. Three suppliers are listed for this compound. There are five tentative approvals for this compound.

Recent Clinical Trials for ticagrelor

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

SponsorPhase
University of Texas Southwestern Medical CenterPhase 2
China National Center for Cardiovascular DiseasesPhase 4
Asan Medical CenterPhase 4

See all ticagrelor clinical trials

Generic filers with tentative approvals for TICAGRELOR
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing90MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing90MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing60MGTABLET;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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hisun Pharm Hangzhou TICAGRELOR ticagrelor TABLET;ORAL 208575-001 Jan 23, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 022433-001 Jul 20, 2011 See Plans and Pricing See Plans and Pricing
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 See Plans and Pricing See Plans and Pricing
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 See Plans and Pricing See Plans and Pricing
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 See Plans and Pricing See Plans and Pricing
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 See Plans and Pricing See Plans and Pricing
>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
Japan 2022033919 心筋梗塞の病歴がある患者においてアテローム血栓性イベントを治療または予防する方法 (METHOD OF TREATING OR PREVENTING ATHEROTHROMBOTIC EVENTS IN PATIENTS WITH HISTORY OF MYOCARDIAL INFARCTION) See Plans and Pricing
South Korea 20090055561 트리아졸로[4,5-D]피리미딘 유도체를 포함하는 경구 투여용으로 적합한 조성물 (COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4,5-D]PYRIMIDIN DERIVATE) See Plans and Pricing
Philippines 12013501627 COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4, 5-D]PYRIMIDIN DERIVATIVE See Plans and Pricing
Brazil PI9915883 "composto de triazolo [ 4,5-d] pirimidina, e, composição farmacêutica" See Plans and Pricing
South Korea 100764417 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ticagrelor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1135391 1190009-9 Sweden See Plans and Pricing PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203
1135391 CA 2011 00013 Denmark See Plans and Pricing PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
1135391 PA2011004,C1135391 Lithuania See Plans and Pricing 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
1135391 PA2011004 Lithuania See Plans and Pricing 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
1135391 122011100004 Germany See Plans and Pricing PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Baxter
AstraZeneca
McKinsey
Mallinckrodt
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.