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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
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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 |
Generic filers with tentative approvals for TICAGRELOR
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 90MG | TABLET;ORAL |
Start Trial | Start Trial | 90MG | TABLET;ORAL |
Start Trial | Start Trial | 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 | 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 |
International Patents for ticagrelor
Country | Patent Number | Estimated Expiration |
---|---|---|
European Patent Office | 1386909 | Start Trial |
European Patent Office | 1289992 | Start Trial |
Mexico | 2009001853 | Start Trial |
>Country | >Patent Number | >Estimated 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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