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BRILINTA Drug Profile
» See Plans and Pricing
Which patents cover Brilinta, and when can generic versions of Brilinta launch?
Brilinta is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and twenty-two patent family members in forty-eight 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.
US ANDA Litigation and Generic Entry Outlook for Brilinta
A generic version of BRILINTA was approved as ticagrelor by HISUN PHARM HANGZHOU on January 23rd, 2019.
Summary for BRILINTA
| International Patents: | 222 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 85 |
| Clinical Trials: | 81 |
| Patent Applications: | 1,020 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BRILINTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRILINTA |
| DailyMed Link: | BRILINTA at DailyMed |
Recent Clinical Trials for BRILINTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Iqvia Pty Ltd | Phase 3 |
| AstraZeneca | Phase 3 |
| Janssen, LP | Phase 4 |
Pharmacology for BRILINTA
| 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 BRILINTA
| 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 BRILINTA
| 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 | 022433-001 | Jul 20, 2011 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-002 | Sep 3, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-001 | Jul 20, 2011 | AB | RX | Yes | Yes | 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 | Y | Start Trial | ||
| Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-002 | Sep 3, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| 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 | 022433-002 | Sep 3, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | 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 BRILINTA
| 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 |
| Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-001 | Jul 20, 2011 | 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 BRILINTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Argentina | 072756 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0192262 | Start Trial |
| Russian Federation | 2017129068 | Start Trial |
| Hong Kong | 1246685 | Start Trial |
| Argentina | 062451 | Start Trial |
| Russian Federation | 2418802 | Start Trial |
| Mexico | 2009001853 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BRILINTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1135391 | 2011/012 | Ireland | Start Trial | PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203 |
| 1135391 | C01135391/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 1135391 | 122011100004 | Germany | Start Trial | PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203 |
| 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 | PA2011004 | Lithuania | Start Trial | 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 |
| 1135391 | 91819 | Luxembourg | Start Trial | 91819, EXPIRES: 20241202 |
| 1135391 | 406 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
