Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Medtronic
Merck
Express Scripts
Colorcon
McKesson
Harvard Business School

Last Updated: May 26, 2022

NUCYNTA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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 eight patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-three 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. Two suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.

DrugPatentWatch® 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.

Indicators of Generic Entry

< Available with Subscription >

  Sign up for a Free Trial

Drug patent expirations by year for NUCYNTA
Drug Prices for NUCYNTA

See drug prices for NUCYNTA

DrugPatentWatch® Estimated 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
GrĂ¼nenthal GmbHPhase 4
Ortho-McNeil Janssen Scientific Affairs, LLCPhase 3
GrĂ¼nenthal GmbHPhase 3

See all NUCYNTA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NUCYNTA
Paragraph IV (Patent) Challenges for NUCYNTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NUCYNTA Oral Solution tapentadol hydrochloride 20 mg/mL 203794 1 2013-12-20
NUCYNTA Tablets tapentadol hydrochloride 50 mg, 75 mg, and 100 mg 022304 4 2012-11-20

US Patents and Regulatory Information for NUCYNTA

NUCYNTA is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUCYNTA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN

Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELIEF OF MODERATE TO SEVERE ACUTE PAIN

1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN

1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELIEF OF MODERATE TO SEVERE ACUTE PAIN

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 200533-002 Aug 25, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 TABLET;ORAL 022304-003 Nov 20, 2008 See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008 See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NUCYNTA

When does loss-of-exclusivity occur for NUCYNTA?

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

Argentina

Patent: 9949
Estimated Expiration: See Plans and Pricing

Patent: 6052
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05256512
Estimated Expiration: See Plans and Pricing

Austria

Patent: 8639
Estimated Expiration: See Plans and Pricing

Patent: 6021
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0512792
Estimated Expiration: See Plans and Pricing

Patent: 2018014454
Estimated Expiration: See Plans and Pricing

Canada

Patent: 72147
Estimated Expiration: See Plans and Pricing

China

Patent: 97621
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0110050
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 06929
Estimated Expiration: See Plans and Pricing

Patent: 11530
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 12203
Estimated Expiration: See Plans and Pricing

Patent: 99633
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 17046065
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 12203
Estimated Expiration: See Plans and Pricing

Patent: 99633
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004007905
Estimated Expiration: See Plans and Pricing

Patent: 2005026031
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0373
Estimated Expiration: See Plans and Pricing

Japan

Patent: 90764
Estimated Expiration: See Plans and Pricing

Patent: 08504326
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06014741
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1605
Estimated Expiration: See Plans and Pricing

Norway

Patent: 8605
Estimated Expiration: See Plans and Pricing

Patent: 1239
Estimated Expiration: See Plans and Pricing

Patent: 3922
Estimated Expiration: See Plans and Pricing

Patent: 070162
Estimated Expiration: See Plans and Pricing

Patent: 160914
Estimated Expiration: See Plans and Pricing

Patent: 171103
Estimated Expiration: See Plans and Pricing

Peru

Patent: 060372
Estimated Expiration: See Plans and Pricing

Poland

Patent: 12203
Estimated Expiration: See Plans and Pricing

Patent: 99633
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 12203
Estimated Expiration: See Plans and Pricing

Patent: 99633
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 23345
Estimated Expiration: See Plans and Pricing

Patent: 07103297
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 12203
Estimated Expiration: See Plans and Pricing

Patent: 99633
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0700774
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1096501
Estimated Expiration: See Plans and Pricing

Patent: 070039929
Estimated Expiration: See Plans and Pricing

Spain

Patent: 91780
Estimated Expiration: See Plans and Pricing

Patent: 59504
Estimated Expiration: See Plans and Pricing

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 around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 0743853 COMPOSES AGISSANT AU NIVEAU D'UN NOUVEAU SITE SUR DES CANAUX CALCIQUES ACTIVES PAR DES RECEPTEURS, ET UTILISES DANS LE TRAITEMENT DE TROUBLES ET DE MALADIES NEUROLOGIQUES (COMPOUNDS ACTIVE AT A NOVEL SITE ON RECEPTOR-OPERATED CALCIUM CHANNELS USEFUL FOR TREATMENT OF NEUROLOGICAL DISORDERS AND DISEASES) See Plans and Pricing
China 1153568 See Plans and Pricing
Denmark 0831799 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NUCYNTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475 PA2011007 Lithuania See Plans and Pricing 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 See Plans and Pricing 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 PA2011007,C0693475 Lithuania See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
AstraZeneca
Express Scripts
Johnson and Johnson
Merck

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.