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NUCYNTA Drug Profile
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Which 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. One supplier is 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.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 27, 2025. This may change due to patent challenges or generic licensing.
There have been seven 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: | 1 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 6 |
| Patent Applications: | 2,204 |
| 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 |
Generic Entry Opportunity Date for NUCYNTA
Generic Entry Dates for NUCYNTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL |
Generic Entry Dates for NUCYNTA*:
Constraining patent/regulatory exclusivity:
NDA:
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 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 |
Pharmacology for NUCYNTA
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
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 | 200533-005 | Aug 25, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | 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 | Y | Y | Start Trial | ||
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | SOLUTION;ORAL | 203794-001 | Oct 15, 2012 | DISCN | Yes | No | Start Trial | Start Trial | Y | 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 NUCYNTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 022304-002 | Nov 20, 2008 | Start Trial | Start Trial |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | Start Trial | Start Trial |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | 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 |
|---|---|---|
| Hong Kong | 1008980 | Start Trial |
| Ecuador | SP17046065 | Start Trial |
| China | 1125221 | Start Trial |
| Japan | 4846552 | Start Trial |
| Austria | 496021 | Start Trial |
| Finland | 114704 | Start Trial |
| Japan | 2009143927 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NUCYNTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0693475 | PA2011007 | Lithuania | Start Trial | 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 |
| 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 | 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 | CA 2010 00036 | Denmark | Start Trial | |
| 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 | 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 |
| 0693475 | 91793 | Luxembourg | Start Trial | 91793, EXPIRES: 20200712 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
