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NUCYNTA Drug Profile
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» See Plans and PricingWhich patents cover Nucynta, and what generic alternatives are available?
Nucynta is a drug marketed by Collegium Pharm Inc and is included in three NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.
This drug has eighty-two patent family members in thirty-four countries.
The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Nucynta
Nucynta was eligible for patent challenges on November 20, 2012.
There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are two tentative approvals for the generic drug (tapentadol hydrochloride), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for NUCYNTA
| International Patents: | 82 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 6 |
| Patent Applications: | 1,032 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NUCYNTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NUCYNTA |
| DailyMed Link: | NUCYNTA at DailyMed |
Recent Clinical Trials for NUCYNTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Grünenthal GmbH | Phase 4 |
| Ortho-McNeil Janssen Scientific Affairs, LLC | Phase 3 |
| Grünenthal GmbH | Phase 3 |
Recent Litigation for NUCYNTA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Celltrion Healthcare Co., Ltd. v. Janssen Biotech, Inc. | 2014-03-31 |
| GRUNENTHAL GMBH v. ALKEM LABORATORIES LIMITED | 2013-12-23 |
| Janssen Pharmaceuticals, Inc. v. Roxane Laboratories, Inc. | 2013-11-15 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2016-01-15 |
Pharmacology for NUCYNTA
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
Synonyms for NUCYNTA
| (-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride |
| (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride |
| (1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol |
| (R,R)-Tapentadol |
| 175591-09-0 |
| 175591-23-8 |
| 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 |
| 3-((1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl)phenol hydrochloride |
| 3-((2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl)phenol |
| 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 |
| 3-[(2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl]phenol |
| 3-[(2R,3R)-1-dimethylamino-2-methylpentan-3-yl]phenol |
| 3-[1-(Dimethylamino)-2-methylpentan-3-yl]phenol--hydrogen chloride (1/1) |
| 3-[3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol |
| 4084AH |
| 591T238 |
| 71204KII53 |
| AB1008538 |
| AB1008539 |
| ACN-050883 |
| AK-43468 |
| AKOS015951190 |
| AKOS016842888 |
| AR-270/43507984 |
| AX8210956 |
| B-1798 |
| BCP9000118 |
| BDBM50386381 |
| BN 200 |
| BN 200 (BASE) |
| BN-200 |
| BN-200 HYDROCHLORIDE |
| CG 5503 |
| CG-5503 |
| CG-5503 HYDROCHLORIDE |
| CG5503 |
| CG5503 (BASE) |
| CG5503 HYDROCHLORIDE |
| CG5503 IR |
| CHEBI:135935 |
| CHEMBL1201776 |
| CHEMBL1201777 |
| CS-0879 |
| CS-M0020 |
| D06007 |
| D10199 |
| DB06204 |
| DEA No. 9780 |
| DTXSID00938677 |
| DTXSID30170003 |
| EBD2202137 |
| FT-0674809 |
| FT-0699883 |
| GTPL7477 |
| H8A007M585 |
| HSDB 8309 |
| HY-70042A |
| JNS-024 ER |
| KS-00000OJT |
| KWTWDQCKEHXFFR-SMDDNHRTSA-N |
| MFCD00944992 |
| Nucynta (TN) |
| Nucynta ER |
| Palexia |
| Palexia retard |
| Palexia SR |
| Phenol, 3-((1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl)- |
| phenol, 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]- |
| Phenol, 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-, hydrochloride |
| Phenol,3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]- |
| Q27265914 |
| Q414463 |
| QC-1146 |
| R-331333 |
| SB17333 |
| SB17334 |
| SCHEMBL116924 |
| SCHEMBL238138 |
| ST24049325 |
| Tapentadol |
| Tapentadol (hydrochloride) |
| Tapentadol (USAN/INN) |
| Tapentadol [USAN:INN] |
| Tapentadol HCl |
| Tapentadol hydrochloride |
| 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 |
| UNII-H8A007M585 |
| W-5241 |
| X4992 |
| ZELFLGGRLLOERW-YECZQDJWSA-N |
| ZINC20783 |
Paragraph IV (Patent) Challenges for NUCYNTA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NUCYNTA | SOLUTION;ORAL | tapentadol hydrochloride | 203794 | 2013-12-20 |
| NUCYNTA | TABLET;ORAL | tapentadol hydrochloride | 022304 | 2012-11-20 |
US Patents and Regulatory Information for NUCYNTA
| 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 | 200533-004 | Aug 25, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | RX | Yes | No | Start Trial | Start Trial | 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 NUCYNTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | Start Trial | Start Trial |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | SOLUTION;ORAL | 203794-001 | Oct 15, 2012 | Start Trial | Start Trial |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | Start Trial | Start Trial |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-002 | Nov 20, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NUCYNTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1148337 | Start Trial |
| Canada | 2560002 | Start Trial |
| China | 1192679 | Start Trial |
| Russian Federation | 2246300 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NUCYNTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | SPC/GB11/031 | United Kingdom | Start Trial | 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 | CA 2010 00036 | Denmark | Start Trial | |
| 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 |
