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Serving leading biopharmaceutical companies globally:

McKinsey
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Boehringer Ingelheim
Harvard Business School
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Cerilliant
Merck
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Generated: December 13, 2017

DrugPatentWatch Database Preview

NUCYNTA Drug Profile

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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.

This drug has one hundred and twenty-eight patent family members in thirty-three countries and eleven supplementary protection certificates in nine countries.

The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Drug patent expirations by year for NUCYNTA

Pharmacology for NUCYNTA

Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-003Aug 25, 2011RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-004Aug 25, 2011RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-003Aug 25, 2011RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-004Aug 25, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-004Aug 25, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-005Aug 25, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-002Aug 25, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-002Aug 25, 2011RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-002Aug 25, 2011RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Depomed IncNUCYNTAtapentadol hydrochlorideSOLUTION;ORAL203794-001Oct 15, 2012RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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Expired Patents for Tradename: NUCYNTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed IncNUCYNTAtapentadol hydrochlorideTABLET;ORAL022304-002Nov 20, 2008► Subscribe► Subscribe
Depomed IncNUCYNTAtapentadol hydrochlorideSOLUTION;ORAL203794-001Oct 15, 2012► Subscribe► Subscribe
Depomed IncNUCYNTAtapentadol hydrochlorideTABLET;ORAL022304-001Nov 20, 2008► Subscribe► Subscribe
Depomed IncNUCYNTAtapentadol hydrochlorideTABLET;ORAL022304-003Nov 20, 2008► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for NUCYNTA

Drugname Dosage Strength RLD Submissiondate
tapentadol hydrochlorideTabletsx50 mg, 75 mg, and 100 mgNucynta11/20/2012
tapentadol hydrochlorideExtended-release Tablets50 mg, 100 mg, 150 mg, 200 mg, and 250 mgNucynta ER11/20/2012
tapentadolOral Solution20 mg/mLNucynta12/30/2013
tapentadolOral Solution20 mg/mLNucynta12/20/2013

Non-Orange Book Patents for Tradename: NUCYNTA

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
7,268,166Compounds 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
6,248,737 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects► Subscribe
6,344,558 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effect► Subscribe
7,087,765Compounds 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
6,211,245 Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases► Subscribe
6,051,610 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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International Patent Family for Tradename: NUCYNTA

Country Document Number Estimated Expiration
China1192679► Subscribe
Japan4034366► Subscribe
Poland323871► Subscribe
Finland114704► Subscribe
Canada2572147► Subscribe
Japan2004002437► Subscribe
JapanH09509484► Subscribe
Japan2012102130► Subscribe
World Intellectual Property Organization (WIPO)9640097► Subscribe
Australia716122► 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 Certificates for Tradename: NUCYNTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0016France► SubscribePRODUCT NAME: TAPENTADOL SOUS FORME DE SA BASE LIBRE OU SOUS FORME D'UN DE SES SELS D'ACIDES ACCEPTABLES DU POINT DE VUE PHYSIOLOGIQUE; NAT. REGISTRATION NO/DATE: NL40884 20111003; FIRST REGISTRATION: DE - 76261.00.00 20100819
2011007,C0693475Lithuania► SubscribePRODUCT NAME: TAPENTADOLUM; NAT. REGISTRATION NO/DATE: LT/1/10/2341/001 - LT/1/10/2341/66, 2011 02 19; LT/1/10/2342/001 - LT/1/10/2342/110 20110219; FIRST REGISTRATION: 75043.00.00 - 75048.00.00, 2010 08 19; 76261.00.00 - 76270.00.00 20100819
00541Netherlands► SubscribePRODUCT 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
793Luxembourg► Subscribe91793, EXPIRES: 20200712
C/GB11/031United Kingdom► SubscribePRODUCT NAME: TAPENTADOL IN THE FORM OF ITS BASE OR A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY THE HYDROCHLORIDE SALT.; REGISTERED: DE 75043 20100819; UK PL 21727/0032 - 0050 20110204
2010 00036Denmark► SubscribePRODUCT 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
2011007Lithuania► SubscribePRODUCT NAME: TAPENTADOLUM; NAT. REGISTRATION NO/DATE: LT/1/10/2341/001 - LT/1/10/2341/66, 2011 02 19; LT/1/10/2342/001 - LT/1/10/2342/110 20110219; FIRST REGISTRATION: 75043.00.00 - 75048.00.00, 2010 08 19; 76261.00.00 - 76270.00.00 20100819
0693475/01Switzerland► SubscribePRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
90004-0.LSweden► SubscribePRODUCT 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 00036Denmark► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Fuji
Cantor Fitzgerald
US Department of Justice
AstraZeneca
Mallinckrodt
Chubb
Colorcon
McKinsey

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