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Ticagrelor - Generic Drug Details

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Ticagrelor is the generic ingredient in one branded drug marketed by Astrazeneca Lp and is included in one NDA. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and fifteen patent family members in forty-four countries.

There are eighteen drug master file entries for ticagrelor. Three suppliers are listed for this compound.

Summary for Generic Name: ticagrelor

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list18
Suppliers / Packaging: see list3
Formulation / Manufacturing:see details

Clinical Trials for: ticagrelor

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Lp
BRILINTA
ticagrelor
TABLET;ORAL022433-002Sep 3, 2015RXNo6,525,060<disabled>YY <disabled>
Astrazeneca Lp
BRILINTA
ticagrelor
TABLET;ORAL022433-001Jul 20, 2011RXYes6,525,060<disabled>YY <disabled>
Astrazeneca Lp
BRILINTA
ticagrelor
TABLET;ORAL022433-001Jul 20, 2011RXYes7,250,419<disabled>YY <disabled>
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Non-Orange Book Patents for Generic Ingredient: ticagrelor

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,974,868 Compounds<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ticagrelor

Country Document Number Estimated Expiration
Taiwan530058<disabled in preview>
China1270590<disabled in preview>
Japan2014129423<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TICAGRELOR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
11/012Ireland<disabled>PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
2011004,C1135391Lithuania<disabled>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
6Finland<disabled>
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