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Serving leading biopharmaceutical companies globally:

Julphar
Fuji
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Colorcon
Teva
Queensland Health
Novartis
QuintilesIMS
Farmers Insurance
Healthtrust

Generated: February 19, 2018

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 seven patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-six patent family members in thirty-three countries.

The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for NUCYNTA
Drug patent expirations by year for NUCYNTA
Pharmacology for NUCYNTA
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists

US Patents and Regulatory Information for NUCYNTA

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 200533-004 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Depomed Inc NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for NUCYNTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed Inc NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012 ➤ Sign Up ➤ Sign Up
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for NUCYNTA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets x50 mg, 75 mg, and 100 mg ➤ Subscribe 11/20/2012
➤ Subscribe Extended-release Tablets 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg ➤ Subscribe 11/20/2012
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe 12/30/2013
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe 12/20/2013

Non-Orange Book US Patents for 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
6,248,737 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects ➤ Sign Up
6,344,558 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effect ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for NUCYNTA

Supplementary Protection Certificates for NUCYNTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475/01 Switzerland ➤ Sign Up PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
C/GB11/031 United Kingdom ➤ Sign Up PRODUCT 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
90004-0.L Sweden ➤ Sign Up 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 ➤ Sign Up 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
2010 00036 Denmark ➤ Sign Up
11/010 Ireland ➤ Sign Up 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
C0016 France ➤ Sign Up PRODUCT 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 Lithuania ➤ Sign Up PRODUCT 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
2011007,C0693475 Lithuania ➤ Sign Up PRODUCT 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
00541 Netherlands ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Cantor Fitzgerald
Johnson and Johnson
Fish and Richardson
Daiichi Sankyo
Citi
UBS
Moodys
Express Scripts

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