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Generated: June 24, 2017
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 six patents protecting this drug and two Paragraph IV challenges.| Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 3 |
| Bulk Api Vendors: see list | 46 |
| Clinical Trials: see list | 65 |
| Patent Applications: see list | 91 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | BRILINTA at DailyMed |
| 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 |
| 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 | RE46276 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-002 | Sep 3, 2015 | RX | Yes | No | 8,425,934 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-001 | Jul 20, 2011 | RX | Yes | Yes | 6,251,910 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-002 | Sep 3, 2015 | RX | Yes | No | RE46276 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Astrazeneca Pharms | BRILINTA | ticagrelor | TABLET;ORAL | 022433-001 | Jul 20, 2011 | RX | Yes | Yes | 8,425,934 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ticagrelor | Tablets | 60 mg | Brilinta | 9/30/2015 |
| ticagrelor | Tablets | 90 mg | Brilinta | 7/20/2015 |
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 | ► Subscribe | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| China | 1270590 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 69915675 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2012153069 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 522638 | ► Subscribe | |||||||||||||||||||||||||||
| Cyprus | 1113047 | ► Subscribe | |||||||||||||||||||||||||||
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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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0016 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 11/012 | Ireland | ► Subscribe | PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203 | ||||||||||||||||||||||||||
| C/GB11/016 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 819 | Luxembourg | ► Subscribe | 91819, EXPIRES: 20241202 | ||||||||||||||||||||||||||
| 2011004 | Lithuania | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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