Ticagrelor - Generic Drug Details

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What are the generic drug 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
Giorgio Quadri	Phase 3

See all ticagrelor clinical trials

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	90MG	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

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs Inc	TICAGRELOR	ticagrelor	TABLET;ORAL	208390-002	Sep 4, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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
>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

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ticagrelor

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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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1386921	Intermédiares pour la préparation des dérivés anti-thrombotiques de 4H-cyclopenta-1,3-dioxoles (Intermediates for the preparation of anti-thrombotic 4H-cyclopenta-1,3-dioxol derivatives)	⤷ Sign Up
Poland	201283		⤷ Sign Up
Malaysia	147966	COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4,5-D] PYRIMIDIN DERIVATE	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ticagrelor

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	2011/012	Ireland	⤷ Sign Up	PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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