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Generated: June 22, 2017
What are the generic sources for tapentadol hydrochloride and what is the scope of tapentadol hydrochloride patent protection?
Tapentadol hydrochloride is the generic ingredient in two branded drugs marketed by Depomed Inc and is included in three NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 3 |
| Drug Master File Entries: see list | 4 |
| Suppliers / Packagers: see list | 8 |
| Bulk Api Vendors: see list | 24 |
| Clinical Trials: see list | 2,295 |
| Patent Applications: see list | 218 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | tapentadol hydrochloride at DailyMed |
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | RX | Yes | No | 8,075,872 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | RX | Yes | No | 8,075,872 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | RX | Yes | No | 8,309,060 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | RX | Yes | No | 8,536,130 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | RX | Yes | Yes | RE39593 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Depomed Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-002 | Nov 20, 2008 | 6,071,970 | ► Subscribe | ||||||||||||||||||||||
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | 6,071,970 | ► Subscribe | ||||||||||||||||||||||
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | 6,071,970 | ► Subscribe | ||||||||||||||||||||||
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | 6,071,970 | ► Subscribe | ||||||||||||||||||||||
Depomed Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | 6,071,970 | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,051,610 | Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases | ► Subscribe | |||||||||||||||||||||||||||
| 6,306,912 | Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases | ► Subscribe | |||||||||||||||||||||||||||
| 6,750,244 | Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases | ► Subscribe | |||||||||||||||||||||||||||
| 6,248,737 | 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects | ► Subscribe | |||||||||||||||||||||||||||
| 6,211,245 | Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Slovenia | 1740156 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5064209 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 69434889 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 045353 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20070017459 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010 00036 | Denmark | ► Subscribe | PRODUCT NAME: TAPENTADOL ((1R-2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL), HERUNDER HYDROCHLORIDET; NAT. REG. NO/DATE: 45151-45158, 45162-45169 20100830; FIRST REG. NO/DATE: EU 75043.00.00-75048.00.00, 75261.00.00-75270.00.00 20100819 | ||||||||||||||||||||||||||
| 0693475/01 | Switzerland | ► Subscribe | PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222 | ||||||||||||||||||||||||||
| 90004-0.L | Sweden | ► Subscribe | PRODUCT NAME: TAPENTADOL; NAT. REG. NO/DATE: 42622-42628 20100910; FIRST REG.: DE 7543-7548,7661-76270" EESGODKLANDKOD="DE" EESGODKDATUM="2010-08-19" SEGODKNR="42622-42628 20100819 | ||||||||||||||||||||||||||
| 2010 00036 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 00541 | Netherlands | ► Subscribe | PRODUCT NAME: TAPENTADOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TAPENTADOL HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 110721-110724 RVG 110728-110731 20120316; FIRST REGISTRATION: DE 75043.00.00 - 75045.00.00, 75046.00.00, 76261.00.00 - 76270.00.00 20120819 | ||||||||||||||||||||||||||
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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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