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Last Updated: March 28, 2024

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 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.

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
⤷  Try a Trial⤷  Try a TrialEQ 20MG BASE/MLSOLUTION;ORAL
⤷  Try a Trial⤷  Try a Trial100MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial75MGTABLET;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
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TAPENTADOL HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Argentina 046994 PROCESO PARA LA PRODUCCION DE UNA FORMA DE DOSIFICACION A PRUEBA DE ABUSO ⤷  Try a Trial
Japan 4939218 ⤷  Try a Trial
New Zealand 580415 Dosing regimen for (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol ⤷  Try a Trial
Hong Kong 1099511 METHOD FOR THE PRODUCTION OF AN ADMINISTRATION FORM WHICH IS SECURED AGAINST MISUSE ⤷  Try a Trial
Poland 1612203 ⤷  Try a Trial
Japan 2007533692 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAPENTADOL HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475 C00693475/01 Switzerland ⤷  Try a Trial PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
0693475 PA2011007,C0693475 Lithuania ⤷  Try a Trial 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 PA2011007 Lithuania ⤷  Try a Trial 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 12C0016 France ⤷  Try a Trial 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
0693475 CR 2010 00036 Denmark ⤷  Try a Trial 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 SPC/GB11/031 United Kingdom ⤷  Try a Trial 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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