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
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 |
⤷ Sign Up | ⤷ Sign Up | EQ 20MG BASE/ML | SOLUTION;ORAL |
⤷ Sign Up | ⤷ Sign Up | 100MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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 | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-002 | Nov 20, 2008 | 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 | 200533-002 | Aug 25, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | 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 | 200533-001 | 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 |
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-002 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | 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 |
---|---|---|---|
Germany | 102005005446 | Bruchfeste Darreichungsformen mit retardierter Freisetzung | ⤷ Sign Up |
New Zealand | 551605 | Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride | ⤷ Sign Up |
European Patent Office | 1658055 | FORME GALENIQUE EMPECHANT UN USAGE DETOURNE (FORM OF ADMINISTRATION SECURED AGAINST MISUSE) | ⤷ Sign Up |
Hong Kong | 1107931 | METHOD FOR PRODUCING A SOLID DOSAGE FORM, WHICH IS SAFEGUARDED AGAINST ABUSE, WHILE USING A PLANETARY GEAR EXTRUDER | ⤷ Sign Up |
South Africa | 200705836 | Break-resistant delayed-release forms of administration | ⤷ 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 |
---|---|---|---|---|
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 |
1439829 | 99 1-2011 | Slovakia | ⤷ Sign Up | 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 | 2011/010 | Ireland | ⤷ Sign Up | PRODUCT NAME: TAPENTADOL IN BASIC FORM OR IN THE FORM OF A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY TAPENTADOL HYDROCHLORIDE; NAT REGISTRATION NO/DATE: PA1189/007/001-008 20101221; FIRST REGISTRATION NO/DATE: PA1189/008/001-008 21/12/2010 GERMANY 75043.00.00 75044.00.00 75045.00.00 19/08/2010 GERMANY 76261.00.00 76262.00.00 76263.00.00 76264.00.00 76265.00.00 19/08/2010 GERMANY 75046.00.00 75047.00.00 75048.00.00 19/08/2010 GERMANY 76266.00.00 76267.00.00 76268.00.0076269.00.00 76270.00.00 20100819 |
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 |
0693475 | C300541 | Netherlands | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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