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Last Updated: August 17, 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 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 200533-002 Aug 25, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008 RX Yes No See Plans and Pricing See Plans and Pricing Y Y 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 200533-004 Aug 25, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y 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

International Patents for TAPENTADOL HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Japan 2010520907 See Plans and Pricing
Russian Federation 2006106725 ЗАЩИЩЕННАЯ ОТ ПРИМЕНЕНИЯ НЕ ПО НАЗНАЧЕНИЮ ЛЕКАРСТВЕННАЯ ФОРМА See Plans and Pricing
Denmark 2478896 See Plans and Pricing
Spain 2572166 See Plans and Pricing
Japan 2007516998 See Plans and Pricing
Cyprus 1107738 See Plans and Pricing
Slovenia 693475 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
0693475 SPC/GB11/031 United Kingdom See Plans and Pricing 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
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 CA 2010 00036 Denmark See Plans and Pricing
0693475 1190004-0.L Sweden See Plans and Pricing 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 99 1-2011 Slovakia See Plans and Pricing PRODUCT NAME: TAPENTADOL; NAT. REGISTRATION NO/DATE: 65/0667-0674/10-S, 65/090-0697/10-S 20101012; FIRST REGISTRATION: DE 75043-75048.00.00, 76261-76270.00.00 20100819
0693475 PA2011007 Lithuania See Plans and Pricing 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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