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Generated: June 23, 2017
What are the generic drug sources for dabigatran etexilate mesylate and what is the scope of dabigatran etexilate mesylate patent protection?
Dabigatran etexilate mesylate is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 22 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 44 |
| Clinical Trials: see list | 655 |
| Patent Applications: see list | 137 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | dabigatran etexilate mesylate at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-002 | Oct 19, 2010 | RX | Yes | Yes | 9,034,822 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-002 | Oct 19, 2010 | RX | Yes | Yes | 7,866,474 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-002 | Oct 19, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-001 | Oct 19, 2010 | RX | Yes | No | 9,034,822 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Boehringer Ingelheim | PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512-002 | Oct 19, 2010 | RX | Yes | Yes | 7,932,273 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,486,398 | Anticoagulant antidotes comprising antibodies that bind dabigatran and/or related compounds | ► Subscribe | |||||||||||||||||||||||||||
| 6,414,008 | Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions | ► Subscribe | |||||||||||||||||||||||||||
| 6,710,055 | Disubstituted bicyclic heterocycles, the preparation thereof, and their use as pharmaceutical compositions | ► Subscribe | |||||||||||||||||||||||||||
| 6,469,039 | Disubstituted bicyclic heterocycles, the preparation and the use thereof as pharmaceutical compositions | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Uruguay | 33196 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 201136606 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 173885 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1088702 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2592057 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0349 | Netherlands | ► Subscribe | 300349, 20180216, EXPIRES: 20230215 | ||||||||||||||||||||||||||
| 2008008 | Lithuania | ► Subscribe | PRODUCT NAME: DABIGATRANUM ETEXILATUM, MESYLATUM; REG. NO/DATE: EU/1/08/442/001-008 20080509 | ||||||||||||||||||||||||||
| C020/2008 | Ireland | ► Subscribe | SPC020/2008: 20090921, EXPIRES: 20230215 | ||||||||||||||||||||||||||
| 0966454/01 | Switzerland | ► Subscribe | PRODUCT NAME: DABIGATRANETEXILAT; REGISTRATION NO/DATE: SWISSMEDIC 61385 29.05.2012 | ||||||||||||||||||||||||||
| 2008 00032 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
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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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