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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
Drug Prices:see low prices

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;ORAL022433-001Jul 20, 2011RXYes6,251,910Jul 15, 2018Y
Astrazeneca Lp
BRILINTA
ticagrelor
TABLET;ORAL022433-002Sep 3, 2015RXNo6,525,060Dec 2, 2019YY
Astrazeneca Lp
BRILINTA
ticagrelor
TABLET;ORAL022433-001Jul 20, 2011RXYes7,265,124Jul 9, 2021YY
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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
Norway333289<disabled in preview>
Poland348724<disabled in preview>
Sweden9901271<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
2011 00013Denmark<disabled>
C0016France<disabled>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
11/012Ireland<disabled>PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
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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 verifification 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.

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