DrugPatentWatch Database Preview
BRILINTA Drug Profile
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Which patents cover Brilinta, and when can generic versions of Brilinta launch?
This drug has two hundred and fifty 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. Two suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
Summary for BRILINTA
| International Patents: | 250 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 66 |
| Clinical Trials: | 67 |
| Patent Applications: | 95 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRILINTA |
| DailyMed Link: | BRILINTA at DailyMed |
Generic Entry Opportunity Date for BRILINTA
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
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 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-001 | Jul 20, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | Y | ➤ Sign Up | |
| Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-001 | Jul 20, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-002 | Sep 3, 2015 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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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 | ➤ Sign Up | ➤ Sign Up |
| Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-001 | Jul 20, 2011 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for BRILINTA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 60 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 90 mg | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for BRILINTA
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 | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for BRILINTA
Supplementary Protection Certificates for BRILINTA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2011 00013 | Denmark | ➤ Sign Up | PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF |
| 2011100004 | Germany | ➤ Sign Up | PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203 |
| 1135391/01 | Switzerland | ➤ Sign Up | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 90009-9 | Sweden | ➤ Sign Up | PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
