BRILINTA Drug Patent Profile

Which patents cover Brilinta, and when can generic versions of Brilinta launch?

Brilinta is a drug marketed by Astrazeneca and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and forty-seven patent family members in forty-four countries.

The generic ingredient in BRILINTA is ticagrelor. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Brilinta

A generic version of BRILINTA was approved as ticagrelor by HISUN PHARM HANGZHOU on January 23^rd, 2019.

Summary for BRILINTA

International Patents:	147
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	87
Patent Applications:	1,175
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BRILINTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRILINTA
What excipients (inactive ingredients) are in BRILINTA?	BRILINTA excipients list
DailyMed Link:	BRILINTA at DailyMed

See drug prices for BRILINTA

Recent Clinical Trials for BRILINTA

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

Sponsor	Phase
Yonsei University	Phase 4
University of Florida	Phase 2/Phase 3
Medical University of South Carolina	Phase 2/Phase 3

See all BRILINTA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BRILINTA

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

Paragraph IV (Patent) Challenges for BRILINTA

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 BRILINTA

BRILINTA is protected by ten US patents and two FDA Regulatory Exclusivities.

Patents protecting BRILINTA

FDA Regulatory Exclusivity protecting BRILINTA

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			Y	Y
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015		RX	Yes	No

Expired US Patents for BRILINTA

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

International Patents for BRILINTA

When does loss-of-exclusivity occur for BRILINTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Norway

Philippines

Poland

Portugal

Russian Federation

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BRILINTA around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	068086	POLIMORFOS DEL COMPUESTO TRIAZOLO (4,5-D) PIRIMIDINA , UNA MEZCLA , PROCESO PARA SU PREPARACION , COMPOSICION FARMACEUTICA Y USO DE ESTOS COMPUESTOS PARA LA FABRICACION DE MEDICAMENTOS
Lithuania	2056832
Ukraine	99105	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОИЗВОДНОЕ ТРИАЗОЛО[4,5-d]ПИРИМИДИНА;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ ПОХІДНЕ ТРИАЗОЛО[4,5-d]ПІРИМІДИНУ (PHARMACEUTICAL COMPOSITION COMPRISING A TRIAZOLO [4, 5-D]PYRIMIDIN DERIVATE)

Supplementary Protection Certificates for BRILINTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	91819	Luxembourg		91819, EXPIRES: 20241202
1135391	2011/012	Ireland		PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391	PA2011004,C1135391	Lithuania		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