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Ticagrelor - Generic Drug Details

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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 Pharms, Amneal, Hisun Pharm Hangzhou, Sigmapharm Labs Llc, Sunshine, and Watson Labs Inc, and is included in six NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ticagrelor has two hundred and twenty-two patent family members in forty-eight 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.

Summary for ticagrelor

International Patents:	222
US Patents:	4
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	21
Suppliers / Packagers:	3
Bulk Api Vendors:	85
Clinical Trials:	349
Patent Applications:	2,133
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ticagrelor
DailyMed Link:	ticagrelor at DailyMed

Recent Clinical Trials for ticagrelor

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

Sponsor	Phase
Fundación EPIC	Phase 4
Military Institute of Medicine, Poland	Phase 4
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland	Phase 4

See all ticagrelor clinical trials

Generic filers with tentative approvals for TICAGRELOR

Applicant	Application No.	Strength	Dosage Form
		90MG	TABLET;ORAL
		90MG	TABLET;ORAL
		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	Phenylalanine Hydroxylase Activators P2Y12 Receptor Antagonists Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors
Physiological Effect	Decreased Platelet Aggregation

Paragraph IV (Patent) Challenges for TICAGRELOR

Tradename	Dosage	Ingredient	NDA	Submissiondate
BRILINTA	TABLET;ORAL	ticagrelor	022433	2015-09-30
BRILINTA	TABLET;ORAL	ticagrelor	022433	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 Pharms	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015		RX	Yes	No			Y	Y
Astrazeneca Pharms	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes
Watson Labs Inc	TICAGRELOR	ticagrelor	TABLET;ORAL	208390-001	Sep 4, 2018		DISCN	No	No

Expired US Patents for ticagrelor

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

International Patents for ticagrelor

Country	Patent Number	Estimated Expiration
European Patent Office	1386909
European Patent Office	1289992
Mexico	2009001853

Supplementary Protection Certificates for ticagrelor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	1190009-9	Sweden		PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203
1135391	CA 2011 00013	Denmark		PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
1135391	SPC/GB11/016	United Kingdom		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