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Last Updated: August 11, 2022

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 nine patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and fifty-three patent family members in thirty-seven countries.

The generic ingredient in NUCYNTA ER 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 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 twenty-nine 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 Generic Entry Opportunity 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
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Phase 3

See all NUCYNTA ER clinical trials

Pharmacology for NUCYNTA ER
Drug ClassOpioid Agonist
Mechanism of Action Opioid 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 fourteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUCYNTA ER 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 ER


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELIEF OF MODERATE TO SEVERE CHRONIC PAIN

Titration of tapentadol
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Titration of tapentadol
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

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 CHRONIC 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: MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY

Abuse-proofed dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-proofed dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Abuse-proofed dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY

Abuse-proofed dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELIEF OF MODERATE TO SEVERE CHRONIC PAIN

Abuse-proofed dosage form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY

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 CHRONIC 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 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 200533-003 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 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 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 See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 See Plans and Pricing See Plans and Pricing
>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: 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 ER around the world.

Country Patent Number Title Estimated Expiration
South Korea 20070017459 DOSAGE FORM THAT IS SAFEGUARDED FROM ABUSE See Plans and Pricing
Brazil PI0213653 formulação farmacêutica que contém o 3-(3-dimetil-amino1-etil-2metil-propil) fenol e proporciona uma liberação retardada do ingrediente ativo See Plans and Pricing
Germany 10336400 Gegen Missbrauch gesicherte Darreichungsform See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NUCYNTA ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1439829 99 1-2011 Slovakia See Plans and Pricing PRODUCT NAME: TAPENTADOL; NAT. REGISTRATION NO/DATE: 65/0667-0674/10-S, 65/090-0697/10-S 20101012; FIRST REGISTRATION: DE 75043-75048.00.00, 76261-76270.00.00 20100819
0693475 12C0016 France See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Mallinckrodt
Medtronic
McKesson
Johnson and Johnson

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.