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Last Updated: April 17, 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, Sigmapharm Labs Llc, Sunshine, and Watson Labs Inc, and is included in eight 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-six 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:	146
US Patents:	3
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	411
Patent Applications:	1,985
Formulation / Manufacturing:	see details
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
Azienda Ospedaliera Universitaria Policlinico "G. Martino"	Phase 3
Gianluca Di Bella	Phase 3
Antonio Micari	Phase 3

See all ticagrelor clinical trials

Generic filers with tentative approvals for TICAGRELOR

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	90MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	90MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Sigmapharm Labs Llc	TICAGRELOR	ticagrelor	TABLET;ORAL	208596-001	Apr 7, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs Inc	TICAGRELOR	ticagrelor	TABLET;ORAL	208390-001	Sep 4, 2018		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	⤷ Try a Trial	⤷ Try a Trial
>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
Canada	2659328	COMPOSITIONS POUR ADMINISTRATION ORALE COMPRENANT UN DERIVE DE TRIAZOLO [4, 5] PYRIMIDINE (COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING ATRIAZOLO [4,5-D]PYRIMIDIN DERIVATE)	⤷ Try a Trial
Chile	2007002421	COMPOSICION FARMACEUTICA QUE COMPRENDE {1S-[1ALFA,2ALFA,3BETA (1S, 2R),5BETA]}-3-(7-{[2-(3,4-DIFLUOROFENIL)CICLOPROPIL]AMINO}-5-(PROPILTIO)-3H-1,2,3-TRIAZOLO[4,5-D]PIRIMIDIN-3-L)-5-(2-HIDROXIETOXI)CICLOPENTANO-1,2-DIOL, UNA O MAS CARGAS, AGLUTINANT	⤷ Try a Trial
Canada	2974894	METHODE DE TRAITEMENT OU DE PREVENTION D'EVENEMENTS ATHEROTHROMBOTIQUES CHEZ DES PATIENTS PRESENTANT DES ANTECEDENTS D'INFARCTUS DU MYOCARDE (METHOD OF TREATING OR PREVENTION OF ATHEROTHROMBOTIC EVENTS IN PATIENTS WITH HISTORY OF MYOCARDIAL INFARCTION)	⤷ Try a Trial
Czech Republic	300373	Nové slouceniny (Novel compounds)	⤷ Try a Trial
Brazil	9915883		⤷ Try a Trial
>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	91819	Luxembourg	⤷ Try a Trial	91819, EXPIRES: 20241202
1135391	406	Finland	⤷ Try a Trial
1135391	1190009-9	Sweden	⤷ Try a Trial	PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203
1135391	C01135391/01	Switzerland	⤷ Try a Trial	FORMER REPRESENTATIVE: BOHEST AG, CH
1135391	CA 2011 00013	Denmark	⤷ Try a Trial	PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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.