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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 tapentadol hydrochloride patent protection?
Tapentadol hydrochloride
is the generic ingredient in two branded drugs marketed by Depomed 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 fifty-five patent family members in thirty-seven countries.
There are five drug master file entries for tapentadol hydrochloride. Four suppliers are listed for this compound.
Summary for tapentadol hydrochloride
| International Patents: | 255 |
| US Patents: | 7 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Drug Master File Entries: | 5 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 35 |
| Clinical Trials: | 63 |
| Patent Applications: | 249 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tapentadol hydrochloride |
| DailyMed Link: | tapentadol hydrochloride at DailyMed |
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 (TN) |
| Nucynta ER |
| Palexia retard |
| Palexia SR |
| Phenol, 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-, hydrochloride |
| R-331333 |
| SCHEMBL238138 |
| ST24049325 |
| Tapentadol (hydrochloride) |
| Tapentadol HCl |
| Tapentadol HCl (1.0 mg/mL in Methanol) |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Depomed Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Depomed 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 |
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Expired US Patents for tapentadol hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | ➤ Sign Up | ➤ Sign Up |
| Depomed Inc | NUCYNTA | tapentadol hydrochloride | SOLUTION;ORAL | 203794-001 | Oct 15, 2012 | ➤ Sign Up | ➤ Sign Up |
| Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | ➤ Sign Up | ➤ Sign Up |
| Depomed Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | ➤ Sign Up | ➤ Sign Up |
| Depomed Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | ➤ Sign Up | ➤ Sign Up |
| Depomed Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for tapentadol hydrochloride
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,248,737 | 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects | ➤ Sign Up |
| 6,344,558 | 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effect | ➤ Sign Up |
| 8,114,384 | Process for the production of an abuse-proofed solid dosage form | ➤ Sign Up |
| 8,192,722 | Abuse-proof dosage form | ➤ Sign Up |
| 8,323,889 | Process for the production of an abuse-proofed solid dosage form | ➤ Sign Up |
| 9,629,807 | Abuse-proofed dosage form | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for tapentadol hydrochloride
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Germany | 102004020220 | ➤ Sign Up |
| Slovenia | 1699440 | ➤ Sign Up |
| Norway | 20061055 | ➤ Sign Up |
| Denmark | 1658055 | ➤ Sign Up |
| Germany | 102005005446 | ➤ Sign Up |
| Peru | 04822006 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for tapentadol hydrochloride
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2010 00036 | Denmark | ➤ Sign Up | 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 |
| 0693475/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222 |
| 11/010 | 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 |
| 793 | Luxembourg | ➤ Sign Up | 91793, EXPIRES: 20200712 |
| C/GB11/031 | United Kingdom | ➤ Sign Up | 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 |
| 2011007 | Lithuania | ➤ Sign Up | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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