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Last Updated: May 24, 2024

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NUCYNTA Drug Patent 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 four patents protecting this drug and two Paragraph IV challenges.

This drug has forty-five patent family members in twenty-six 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.

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 July 3, 2026. This may change due to patent challenges or generic licensing.

There have been two 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
Drug Prices for NUCYNTA

See drug prices for NUCYNTA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NUCYNTA
Generic Entry Dates for NUCYNTA*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
NDA:
Dosage:
SOLUTION;ORAL
Generic Entry Dates for NUCYNTA*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
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
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 two US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUCYNTA is ⤷  Sign Up.

This potential generic entry date is based on NEW PATIENT POPULATION.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: RELIEF OF MODERATE TO SEVERE ACUTE PAIN

FDA Regulatory Exclusivity protecting NUCYNTA

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008 ⤷  Sign Up ⤷  Sign Up
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 ⤷  Sign Up ⤷  Sign Up
>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: ⤷  Sign Up

Patent: 6052
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 05256512
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 68639
Estimated Expiration: ⤷  Sign Up

Patent: 96021
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0512792
Estimated Expiration: ⤷  Sign Up

Patent: 2018014454
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 72147
Estimated Expiration: ⤷  Sign Up

China

Patent: 97621
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0110050
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 06929
Estimated Expiration: ⤷  Sign Up

Patent: 11530
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 12203
Estimated Expiration: ⤷  Sign Up

Patent: 99633
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 17046065
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 12203
Estimated Expiration: ⤷  Sign Up

Patent: 99633
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2004007905
Estimated Expiration: ⤷  Sign Up

Patent: 2005026031
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 0373
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 90764
Estimated Expiration: ⤷  Sign Up

Patent: 08504326
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 06014741
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 1605
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 8605
Estimated Expiration: ⤷  Sign Up

Patent: 1239
Estimated Expiration: ⤷  Sign Up

Patent: 3922
Estimated Expiration: ⤷  Sign Up

Patent: 070162
Estimated Expiration: ⤷  Sign Up

Patent: 160914
Estimated Expiration: ⤷  Sign Up

Patent: 171103
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 060372
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 12203
Estimated Expiration: ⤷  Sign Up

Patent: 99633
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 12203
Estimated Expiration: ⤷  Sign Up

Patent: 99633
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 23345
Estimated Expiration: ⤷  Sign Up

Patent: 07103297
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 12203
Estimated Expiration: ⤷  Sign Up

Patent: 99633
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0700774
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1096501
Estimated Expiration: ⤷  Sign Up

Patent: 070039929
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 91780
Estimated Expiration: ⤷  Sign Up

Patent: 59504
Estimated Expiration: ⤷  Sign Up

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
Canada 2257234 COMPOSES AGISSANT SUR UN NOUVEAU SITE DES CANAUX A CALCIUM ACTIVES PAR RECEPTEUR ET UTILES POUR TRAITER DES TROUBLES ET DES MALADIES NEUROLOGIQUES (COMPOUNDS ACTIVE AT A NOVEL SITE ON RECEPTOR-OPERATED CALCIUM CHANNELS USEFUL FOR TREATMENT OF NEUROLOGICAL DISORDERS AND DISEASES) ⤷  Sign Up
Australia 6112596 ⤷  Sign Up
Denmark 1612203 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NUCYNTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1439829 C 2011 002 Romania ⤷  Sign Up 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
0693475 PA2011007,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
0693475 1190004-0.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
>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.