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Last Updated: October 2, 2022

TAPENTADOL HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for tapentadol hydrochloride and what is the scope of freedom to operate?

Tapentadol hydrochloride is the generic ingredient in two branded drugs marketed by Collegium Pharm Inc and is included in three NDAs. There are nine patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tapentadol hydrochloride has three hundred and fifty-three patent family members in thirty-seven countries.

There are four drug master file entries for tapentadol hydrochloride. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Recent Clinical Trials for TAPENTADOL HYDROCHLORIDE

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

SponsorPhase
Aretaieion University HospitalN/A
All India Institute of Medical Sciences, BhubaneswarPhase 4
Oslo University HospitalPhase 4

See all TAPENTADOL HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for TAPENTADOL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 20MG BASE/MLSOLUTION;ORAL
See Plans and PricingSee Plans and Pricing100MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing75MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for TAPENTADOL HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of Action Opioid Agonists
Paragraph IV (Patent) Challenges for TAPENTADOL HYDROCHLORIDE
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
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 TAPENTADOL HYDROCHLORIDE

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 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 See Plans and Pricing
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 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 200533-002 Aug 25, 2011 RX Yes No See Plans and Pricing See Plans and Pricing 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 TAPENTADOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 See Plans and Pricing See Plans and Pricing
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 ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 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 TAPENTADOL HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
European Patent Office 1765298 PROCEDE DE PRODUCTION D'UNE FORME POSOLOGIQUE SOLIDE ANTI-ABUS AU MOYEN D'UNE EXTRUDEUSE A VIS PLANETAIRES (METHOD FOR PRODUCING A SOLID DOSAGE FORM, WHICH IS SAFEGUARDED AGAINST ABUSE, WHILE USING A PLANETARY GEAR EXTRUDER) See Plans and Pricing
Portugal 1845956 See Plans and Pricing
Russian Federation 2423345 КРИСТАЛЛИЧЕСКИЕ МОДИФИКАЦИИ ГИДРОХЛОРИДА (-)-(1R,2R)-3-(3-ДИМЕТИЛАМИНО-1-ЭТИЛ-2-МЕТИЛПРОПИЛ)ФЕНОЛА (CRYSTALLINE MODIFICATIONS OF HYDROCHLORIDE (-)-(1R, 2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYLPROPYL)PHENOL) See Plans and Pricing
Japan 2019131598 タペンタドールの用量調節 (TITRATION OF TAPENTADOL) See Plans and Pricing
Israel 173558 DOSAGE FORM THAT IS SAFEGUARDED FROM ABUSE See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAPENTADOL HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1439829 C20110003 00036 Estonia See Plans and Pricing PRODUCT NAME: PALEXIA; REG NO/DATE: RR-4/42 22.10.2010
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 91793 Luxembourg See Plans and Pricing 91793, EXPIRES: 20200712
0693475 CR 2010 00036 Denmark See Plans and Pricing 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 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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