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Last Updated: March 19, 2024

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NUCYNTA ER Drug Patent Profile


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

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

This drug has two hundred and seventy-two patent family members in thirty-one countries.

The generic ingredient in NUCYNTA ER 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.

DrugPatentWatch® Generic Entry Outlook for Nucynta Er

Nucynta Er 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 eighteen 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 three 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 ER
Drug Prices for NUCYNTA ER

See drug prices for NUCYNTA ER

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NUCYNTA ER
Generic Entry Date for NUCYNTA ER*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;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 ER

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 ER clinical trials

Pharmacology for NUCYNTA ER
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Anatomical Therapeutic Chemical (ATC) Classes for NUCYNTA ER
Paragraph IV (Patent) Challenges for NUCYNTA ER
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NUCYNTA ER Extended-release Tablets tapentadol hydrochloride 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg 200533 2 2012-11-20

US Patents and Regulatory Information for NUCYNTA ER

NUCYNTA ER is protected by six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUCYNTA ER is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NUCYNTA ER

Titration of tapentadol
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TITRATING AN OPIOID TO MANAGE PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE

Titration of tapentadol
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TITRATING AN OPIOID TO MANAGE NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY

Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: RELIEF OF MODERATE TO SEVERE CHRONIC PAIN

Abuse-proofed dosage form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY

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 200533-005 Aug 25, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a 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 ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NUCYNTA ER

When does loss-of-exclusivity occur for NUCYNTA ER?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 9949
Estimated Expiration: ⤷  Try a Trial

Patent: 6052
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05256512
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 68639
Estimated Expiration: ⤷  Try a Trial

Patent: 96021
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0512792
Estimated Expiration: ⤷  Try a Trial

Patent: 2018014454
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 72147
Estimated Expiration: ⤷  Try a Trial

China

Patent: 97621
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0110050
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 06929
Estimated Expiration: ⤷  Try a Trial

Patent: 11530
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 12203
Estimated Expiration: ⤷  Try a Trial

Patent: 99633
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 17046065
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 12203
Estimated Expiration: ⤷  Try a Trial

Patent: 99633
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2004007905
Estimated Expiration: ⤷  Try a Trial

Patent: 2005026031
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0373
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 90764
Estimated Expiration: ⤷  Try a Trial

Patent: 08504326
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06014741
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1605
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 8605
Estimated Expiration: ⤷  Try a Trial

Patent: 1239
Estimated Expiration: ⤷  Try a Trial

Patent: 3922
Estimated Expiration: ⤷  Try a Trial

Patent: 070162
Estimated Expiration: ⤷  Try a Trial

Patent: 160914
Estimated Expiration: ⤷  Try a Trial

Patent: 171103
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060372
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 12203
Estimated Expiration: ⤷  Try a Trial

Patent: 99633
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 12203
Estimated Expiration: ⤷  Try a Trial

Patent: 99633
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 23345
Estimated Expiration: ⤷  Try a Trial

Patent: 07103297
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 12203
Estimated Expiration: ⤷  Try a Trial

Patent: 99633
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0700774
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1096501
Estimated Expiration: ⤷  Try a Trial

Patent: 070039929
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 91780
Estimated Expiration: ⤷  Try a Trial

Patent: 59504
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NUCYNTA ER around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3143993 TITRATION DE TAPENTADOL (TITRATION OF TAPENTADOL) ⤷  Try a Trial
Czech Republic 9501904 ⤷  Try a Trial
Australia 723349 ⤷  Try a Trial
Argentina 045353 FORMA DE DOSIFICACION A PRUEBA DE ABUSO ⤷  Try a Trial
Japan 2007501202 ⤷  Try a Trial
Canada 2223978 ⤷  Try a Trial
European Patent Office 2117525 UTILISATION DE COMPOSÉS DE 1-PHÉNYL-3-DIMÉTHYLAMINO-PROPANE POUR TRAITER LA DOULEUR NEUROPATHIQUE (USE OF 1-PHENYL-3-DIMETHYLAMINO-PROPANE COMPOUNDS FOR THE THERAPY OF NEUROPATHY PAIN) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NUCYNTA ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475 CR 2010 00036 Denmark ⤷  Try a 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 SPC/GB11/031 United Kingdom ⤷  Try a 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 C00693475/01 Switzerland ⤷  Try a Trial PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
0693475 2011/010 Ireland ⤷  Try a 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 91793 Luxembourg ⤷  Try a Trial 91793, EXPIRES: 20200712
1439829 C20110003 00036 Estonia ⤷  Try a Trial PRODUCT NAME: PALEXIA; REG NO/DATE: RR-4/42 22.10.2010
1439829 C 2011 002 Romania ⤷  Try a Trial PRODUCT NAME: TAPENTADOL SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO 3279/2011/01 - RO 3279/2011/22; DATE OF NATIONAL AUTHORISATION: 20110228; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DE 75.046; DATE OF FIRST AUTHORISATION IN EEA: 20100819
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.