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Last Updated: November 24, 2024

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 four patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tapentadol hydrochloride has two hundred and seventy-two patent family members in thirty-one countries.

There are four drug master file entries for tapentadol hydrochloride. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for tapentadol hydrochloride
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for tapentadol hydrochloride
Generic Entry Dates for tapentadol hydrochloride*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
Dosage:
SOLUTION;ORAL
Generic Entry Dates for tapentadol hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL
Generic Entry Dates for tapentadol hydrochloride*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
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 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
⤷  Sign Up⤷  Sign UpEQ 20MG BASE/MLSOLUTION;ORAL
⤷  Sign Up⤷  Sign Up100MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up75MGTABLET;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 ActionOpioid Agonists
Anatomical Therapeutic Chemical (ATC) Classes for tapentadol hydrochloride
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 200533-003 Aug 25, 2011 RX Yes No ⤷  Sign Up ⤷  Sign Up 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 Y ⤷  Sign Up
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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 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 200533-002 Aug 25, 2011 ⤷  Sign Up ⤷  Sign Up
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 ⤷  Sign Up ⤷  Sign Up
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for tapentadol hydrochloride

Country Patent Number Title Estimated Expiration
Australia 2004264666 Dosage form that is safeguarded from abuse ⤷  Sign Up
Spain 2336571 ⤷  Sign Up
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) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tapentadol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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 SPC/GB11/031 United Kingdom ⤷  Sign Up PRODUCT NAME: TAPENTADOL IN THE FORM OF ITS BASE OR A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY THE HYDROCHLORIDE SALT.; REGISTERED: DE 75043 20100819; UK PL 21727/0032 - 0050 20110204
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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