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Last Updated: November 30, 2022

Tapentadol hydrochloride - Generic Drug Details


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What are the generic drug sources for tapentadol hydrochloride and what is the scope of patent protection?

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 200533-001 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 200533-004 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 200533-004 Aug 25, 2011 RX Yes No 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 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 200533-001 Aug 25, 2011 See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 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
Germany 10152469 See Plans and Pricing
Canada 2680771 UTILISATION DE COMPOSES DE 1-PHENYL-3-DIMETHYLAMINO-PROPANE POUR TRAITER LA DOULEUR NEUROPATHIQUE (USE OF 1-PHENYL-3-DIMETHYLAMINO-PROPANE COMPOUNDS FOR THE THERAPY OF NEUROPATHY PAIN) See Plans and Pricing
South Africa 200403928 PHARMACEUTICAL CONTAINING 3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)PHENOL AND PROVIDING DELAYED RELEASE OF THE ACTIVE INGREDIENT 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 C 2011 002 Romania See Plans and Pricing 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 C300541 Netherlands See Plans and Pricing PRODUCT NAME: TAPENTADOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TAPENTADOL HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 110721-110724 RVG 110728-110731 20120316; FIRST REGISTRATION: DE 75043.00.00 - 75045.00.00, 75046.00.00, 76261.00.00 - 76270.00.00 20120819
0693475 91793 Luxembourg See Plans and Pricing 91793, EXPIRES: 20200712
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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