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Generated: June 26, 2017
Which patents cover Nucynta, and when can generic versions of Nucynta launch?
Nucynta is a drug marketed by Depomed Inc and is included in three NDAs. There are eight patents protecting this drug and four Paragraph IV challenges.| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: see list | 8 |
| Bulk Api Vendors: see list | 22 |
| Clinical Trials: see list | 6 |
| Patent Applications: see list | 139 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | NUCYNTA 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 | 200533-003 | Aug 25, 2011 | RX | Yes | No | RE39593 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | RX | Yes | No | 8,114,383 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | RX | Yes | No | 7,994,364 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | RX | Yes | No | 8,075,872 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | RX | Yes | No | 8,309,060 | ► Subscribe | 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 | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | 6,071,970 | ► Subscribe | ||||||||||||||||||||||
Depomed Inc | NUCYNTA | tapentadol hydrochloride | SOLUTION;ORAL | 203794-001 | Oct 15, 2012 | 6,071,970 | ► Subscribe | ||||||||||||||||||||||
Depomed Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | 6,071,970 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| tapentadol hydrochloride | Tablets | x50 mg, 75 mg, and 100 mg | Nucynta | 11/20/2012 |
| tapentadol hydrochloride | Extended-release Tablets | 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg | Nucynta ER | 11/20/2012 |
| tapentadol | Oral Solution | 20 mg/mL | Nucynta | 12/30/2013 |
| tapentadol | Oral Solution | 20 mg/mL | Nucynta | 12/20/2013 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,306,912 | Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases | ► Subscribe | |||||||||||||||||||||||||||
| 7,087,765 | Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases | ► Subscribe | |||||||||||||||||||||||||||
| 6,017,965 | Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases | ► Subscribe | |||||||||||||||||||||||||||
| 6,211,245 | Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases | ► Subscribe | |||||||||||||||||||||||||||
| 7,268,166 | 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Korea | 20070039929 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 8092394 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 100430022 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1008980 | ► Subscribe | |||||||||||||||||||||||||||
| Argentina | 049949 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 11/010 | Ireland | ► Subscribe | PRODUCT NAME: TAPENTADOL IN BASIC FORM OR IN THE FORM OF A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY TAPENTADOL HYDROCHLORIDE; NAT REGISTRATION NO/DATE: PA1189/007/001-008 20101221; FIRST REGISTRATION NO/DATE: PA1189/008/001-008 21/12/2010 GERMANY 75043.00.00 75044.00.00 75045.00.00 19/08/2010 GERMANY 76261.00.00 76262.00.00 76263.00.00 76264.00.00 76265.00.00 19/08/2010 GERMANY 75046.00.00 75047.00.00 75048.00.00 19/08/2010 GERMANY 76266.00.00 76267.00.00 76268.00.0076269.00.00 76270.00.00 20100819 | ||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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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