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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 Assertio and Depo Nf, 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-five patent family members in thirty-seven countries.
There are five drug master file entries for tapentadol hydrochloride. Five suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for tapentadol hydrochloride
| International Patents: | 275 |
| US Patents: | 7 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: | 5 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 34 |
| Clinical Trials: | 66 |
| Patent Applications: | 275 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tapentadol hydrochloride |
| DailyMed Link: | tapentadol hydrochloride at DailyMed |
Recent Clinical Trials for tapentadol hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| All India Institute of Medical Sciences, Bhubaneswar | Phase 4 |
| All India Institute of Medical Sciences, Bhubaneswar | N/A |
| Oslo University Hospital | Phase 4 |
Recent Litigation for tapentadol hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Purdue Pharma L.P. v. Ascent Pharmaceuticals, Inc. | 2018-01-11 |
| Purdue Pharma L.P. v. Amneal Pharmaceuticals, LLC | 2018-01-03 |
| Purdue Pharma L.P. v. Kashiv Pharma, LLC | 2018-01-03 |
See all tapentadol hydrochloride litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Rosellini Scientific, LLC | 2016-01-15 |
Generic filers with tentative approvals for TAPENTADOL HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 20MG BASE/ML | SOLUTION;ORAL |
| Start Trial | Start Trial | 100MG | TABLET;ORAL |
| Start Trial | Start Trial | 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 |
Synonyms for tapentadol hydrochloride
| (-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride |
| (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride |
| 175591-09-0 |
| 3-((1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl) phenol hydrochloride |
| 3-((1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-phenol hydrochloride |
| 3-((1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl)phenol hydrochloride |
| 3-((2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl)phenol hydrochloride |
| 3-[(1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol hdrochloride |
| 3-[(1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol Hydrochloride |
| 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride |
| 591T238 |
| 71204KII53 |
| AB1008539 |
| AK-43468 |
| AX8210956 |
| CHEMBL1201777 |
| CS-0879 |
| D10199 |
| EBD2202137 |
| FT-0674809 |
| HY-70042A |
| JNS-024 ER |
| KB-80810 |
| KS-00000OJT |
| MFCD00944992 |
| Nucynta |
| Nucynta (TN) |
| Nucynta ER |
| Palexia retard |
| Palexia SR |
| Phenol, 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-, hydrochloride |
| R-331333 |
| SB17334 |
| SCHEMBL238138 |
| ST24049325 |
| Tapentadol (hydrochloride) |
| Tapentadol HCl |
| Tapentadol hydrochloride (JAN) |
| Tapentadol hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material |
| Tydol|||Zyntap|||3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-phenol hydrochloride |
| UNII-71204KII53 |
| W-5241 |
| X4992 |
| ZELFLGGRLLOERW-YECZQDJWSA-N |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Depo Nf | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Depo Nf | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Depo Nf | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Depo Nf | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Depo Nf | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | RX | Yes | Yes | 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 |
|---|---|---|---|---|---|---|---|
| Depo Nf | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | Start Trial | Start Trial |
| Depo Nf | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-002 | Nov 20, 2008 | Start Trial | Start Trial |
| Assertio | NUCYNTA | tapentadol hydrochloride | SOLUTION;ORAL | 203794-001 | Oct 15, 2012 | Start Trial | Start Trial |
| Depo Nf | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | Start Trial | Start Trial |
| Depo Nf | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for tapentadol hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Croatia | P20110050 | Start Trial |
| New Zealand | 560203 | Start Trial |
| Australia | 685644 | Start Trial |
| Denmark | 1658054 | Start Trial |
| Slovenia | 1658054 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for tapentadol hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0693475 | 2011/010 | Ireland | Start Trial | 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 | Start Trial | 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 | 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 |
| 0693475 | 91793 | Luxembourg | Start Trial | 91793, EXPIRES: 20200712 |
| 0693475 | C300541 | Netherlands | Start Trial | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.