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 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
International Patents: | 272 |
US Patents: | 4 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 3 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 40 |
Clinical Trials: | 67 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tapentadol hydrochloride |
What excipients (inactive ingredients) are in tapentadol hydrochloride? | tapentadol hydrochloride excipients list |
DailyMed Link: | tapentadol hydrochloride at DailyMed |
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
Sponsor | Phase |
---|---|
Aretaieion University Hospital | N/A |
All India Institute of Medical Sciences, Bhubaneswar | Phase 4 |
Oslo University Hospital | Phase 4 |
Generic filers with tentative approvals for TAPENTADOL HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Subscribe | ⤷ Subscribe | EQ 20MG BASE/ML | SOLUTION;ORAL |
⤷ Subscribe | ⤷ Subscribe | 100MG | TABLET;ORAL |
⤷ Subscribe | ⤷ Subscribe | 75MG | TABLET;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 Class | Opioid Agonist |
Mechanism of Action | Opioid 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 | 7,994,364*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | RX | Yes | No | 11,344,512*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | RX | Yes | No | 7,994,364*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | RX | Yes | No | 11,344,512*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | 200533-003 | Aug 25, 2011 | 11,007,156 | ⤷ Subscribe |
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | RE39593 | ⤷ Subscribe |
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | 11,007,156 | ⤷ Subscribe |
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | RE39593 | ⤷ Subscribe |
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | 6,071,970 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for tapentadol hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 1658055 | ⤷ Subscribe | |
European Patent Office | 1799633 | FORMES CRISTALLINES DE CHLORHYDRATE DE (-)-(1R,2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYLPROPYL)-PHENOL POUR UTILISATION COMME AGENT ACTIF DANS DES COMPOSITIONS PHARMACEUTIQUES (CRYSTALLINE FORMS OF (-)-(1R,2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYLPROPYL)-PHENOL HYDROCHLORIDE FOR USE AS ACTIVE INGREDIENT IN PHARMACEUTICAL COMPOSITIONS) | ⤷ Subscribe |
Ecuador | SP17046065 | FORMAS CRISTALINAS DE (-)-(1R,2R)-3-(3-DIMETILAMINO-1-ETIL-2-METILPROPIL)-FENOLHIDROCLORURO (SOLICITUD DIVISIONAL) | ⤷ Subscribe |
Germany | 10361596 | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform | ⤷ Subscribe |
Brazil | PI0606145 | formas farmacêuticas resistentes ao rompimento com liberação sustentada | ⤷ Subscribe |
>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 | ⤷ Subscribe | 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 | CR 2010 00036 | Denmark | ⤷ Subscribe | 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 | 1190004-0.L | Sweden | ⤷ Subscribe | 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 | ⤷ Subscribe | 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 | SPC/GB11/031 | United Kingdom | ⤷ Subscribe | 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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