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Last Updated: February 28, 2021

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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.

Recent Clinical Trials for ticagrelor

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

SponsorPhase
Fundación EPICPhase 4
Military Institute of Medicine, PolandPhase 4
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, PolandPhase 4

See all ticagrelor clinical trials

Generic filers with tentative approvals for TICAGRELOR
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial90MGTABLET;ORAL
  Start Trial  Start Trial90MGTABLET;ORAL
  Start Trial  Start Trial60MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Watson Labs Inc TICAGRELOR ticagrelor TABLET;ORAL 208390-001 Sep 4, 2018 DISCN No No   Start Trial   Start Trial   Start 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

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

Supplementary Protection Certificates for ticagrelor

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

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Serving leading biopharmaceutical companies globally:

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Medtronic

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