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
International Patents: | 147 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 21 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 101 |
Clinical Trials: | 416 |
Patent Applications: | 1,689 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ticagrelor |
What excipients (inactive ingredients) are in ticagrelor? | ticagrelor excipients list |
DailyMed Link: | ticagrelor at DailyMed |
Recent Clinical Trials for ticagrelor
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Zunyi Medical College | Phase 4 |
Fu Wai Hospital, Beijing, China | Phase 4 |
Antonio Micari | Phase 3 |
Generic filers with tentative approvals for TICAGRELOR
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 90MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 90MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 60MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ticagrelor
Drug Class | P2Y12 Platelet Inhibitor |
Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists Cytochrome P450 3A5 Inhibitors Phenylalanine Hydroxylase Activators |
Physiological Effect | Decreased Platelet Aggregation |
Anatomical Therapeutic Chemical (ATC) Classes for ticagrelor
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 | ⤷ Sign Up | |||
Amneal | TICAGRELOR | ticagrelor | TABLET;ORAL | 208531-001 | Jan 23, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Watson Labs Inc | TICAGRELOR | ticagrelor | TABLET;ORAL | 208390-001 | Sep 4, 2018 | DISCN | No | 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 | 022433-001 | Jul 20, 2011 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Astrazeneca | BRILINTA | ticagrelor | TABLET;ORAL | 022433-001 | Jul 20, 2011 | AB | RX | Yes | Yes | ⤷ 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 | ||
>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 | 022433-001 | 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 |
---|---|---|---|
Austria | 513816 | ⤷ Sign Up | |
Luxembourg | 91819 | ⤷ Sign Up | |
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 | ⤷ Sign Up |
Russian Federation | 2017129068 | СПОСОБ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ АТЕРОТРОМБОТИЧЕСКИХ ЯВЛЕНИЙ У ПАЦИЕНТОВ С ИНФАРКТОМ МИОКАРДА В АНАМНЕЗЕ | ⤷ Sign Up |
Colombia | 6150163 | COMPOSICIONES ADECUADAS PARA ADMINISTRACION ORAL QUE COMPRENDE UN DERIVADO DE TRIAZOLO [4,5-D] PIRIMIDINA | ⤷ Sign Up |
Japan | 5415383 | ⤷ Sign Up | |
Poland | 348724 | ⤷ 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 | 406 | Finland | ⤷ Sign Up | |
1135391 | 2011/012 | Ireland | ⤷ Sign Up | PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION 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 | 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 | 11C0016 | France | ⤷ Sign Up | PRODUCT NAME: TICAGRELOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/10/655/001 DU 20101203; REGISTRATION NO/DATE AT EEC: EU/1/10/655/001-006 DU 20101203 |
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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