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Serving leading biopharmaceutical companies globally:

Harvard Business School
Cipla
Accenture
Chubb
AstraZeneca
Daiichi Sankyo
Fish and Richardson
Teva
Merck
Citi

Generated: December 13, 2017

DrugPatentWatch Database Preview

NUCYNTA ER Drug Profile

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When do Nucynta Er patents expire, and when can generic versions of Nucynta Er launch?

Nucynta Er is a drug marketed by Depomed Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in NUCYNTA ER 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 ER

Pharmacology for NUCYNTA ER

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;ORAL200533-004Aug 25, 2011RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-005Aug 25, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-004Aug 25, 2011RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-005Aug 25, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-005Aug 25, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-003Aug 25, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-003Aug 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;ORAL200533-001Aug 25, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-005Aug 25, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: NUCYNTA ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-001Aug 25, 2011► Subscribe► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-004Aug 25, 2011► Subscribe► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-003Aug 25, 2011► Subscribe► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-002Aug 25, 2011► Subscribe► Subscribe
Depomed IncNUCYNTA ERtapentadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL200533-005Aug 25, 2011► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for NUCYNTA ER

Drugname Dosage Strength RLD Submissiondate
tapentadol hydrochlorideExtended-release Tablets50 mg, 100 mg, 150 mg, 200 mg, and 250 mgNucynta ER11/20/2012

Non-Orange Book Patents for Tradename: NUCYNTA ER

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
6,344,558 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effect► Subscribe
8,114,384Process for the production of an abuse-proofed solid dosage form► Subscribe
8,192,722Abuse-proof dosage form► Subscribe
6,248,737 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects► 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
8,323,889Process for the production of an abuse-proofed solid dosage form► Subscribe
6,750,244 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 ER

Country Document Number Estimated Expiration
Israel113901► Subscribe
China1192679► Subscribe
Chile2004002016► Subscribe
Russian Federation2007132975► Subscribe
Japan2007501202► Subscribe
Poland323871► Subscribe
Austria163176► Subscribe
Canada2572147► Subscribe
World Intellectual Property Organization (WIPO)2006082099► Subscribe
Australia685644► 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 ER

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:

Boehringer Ingelheim
Colorcon
Queensland Health
Citi
Covington
Johnson and Johnson
US Department of Justice
McKinsey
UBS
Chubb

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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