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Last Updated: February 26, 2021

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NUCYNTA Drug Profile

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Which patents cover Nucynta, and what generic alternatives are available?

Nucynta is a drug marketed by Collegium Pharm Inc and is included in three NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has eighty-two patent family members in thirty-four countries.

The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Nucynta

Nucynta was eligible for patent challenges on November 20, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 27, 2025. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (tapentadol hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for NUCYNTA
Drug Prices for NUCYNTA

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Generic Entry Opportunity Date for NUCYNTA
Generic Entry Dates for NUCYNTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL
Generic Entry Dates for NUCYNTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for NUCYNTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Grünenthal GmbHPhase 4
Ortho-McNeil Janssen Scientific Affairs, LLCPhase 3
Grünenthal GmbHPhase 3

See all NUCYNTA clinical trials

Pharmacology for NUCYNTA
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Paragraph IV (Patent) Challenges for NUCYNTA
Tradename Dosage Ingredient NDA Submissiondate
NUCYNTA SOLUTION;ORAL tapentadol hydrochloride 203794 2013-12-20
NUCYNTA TABLET;ORAL tapentadol hydrochloride 022304 2012-11-20

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

Expired US Patents for NUCYNTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012   Start Trial   Start Trial
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008   Start Trial   Start Trial
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008   Start Trial   Start Trial
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NUCYNTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475 PA2011007 Lithuania   Start Trial 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
0693475 2011/010 Ireland   Start Trial 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
0693475 CR 2010 00036 Denmark   Start Trial 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 CA 2010 00036 Denmark   Start Trial
0693475 SPC/GB11/031 United Kingdom   Start Trial 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
0693475 C300541 Netherlands   Start Trial 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
0693475 91793 Luxembourg   Start Trial 91793, EXPIRES: 20200712
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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