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Last Updated: July 10, 2020

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Tapentadol hydrochloride - Generic Drug Details

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What are the generic 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 seven 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-six patent family members in thirty-seven countries.

There are five drug master file entries for tapentadol hydrochloride. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for tapentadol hydrochloride

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

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

See all tapentadol hydrochloride clinical trials

Generic filers with tentative approvals for TAPENTADOL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 20MG BASE/MLSOLUTION;ORAL
  Start Trial  Start Trial75MGTABLET;ORAL
  Start Trial  Start Trial100MGTABLET;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 NDA Submissiondate
NUCYNTA SOLUTION;ORAL tapentadol hydrochloride 203794 2013-12-20
NUCYNTA TABLET;ORAL tapentadol hydrochloride 022304 2012-11-20
NUCYNTA ER TABLET, EXTENDED RELEASE;ORAL tapentadol hydrochloride 200533 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   Start Trial   Start Trial Y Y   Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No   Start Trial   Start Trial Y   Start 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 SOLUTION;ORAL 203794-001 Oct 15, 2012   Start Trial   Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011   Start Trial   Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tapentadol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475 PA2011007 Lithuania   Start 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   Start 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   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
McKinsey
Mallinckrodt
Express Scripts
Baxter

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