NUCYNTA Drug Patent 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 four patents protecting this drug and two Paragraph IV challenges.
This drug has forty-five patent family members in twenty-six 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.
DrugPatentWatch® 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 July 3, 2026. This may change due to patent challenges or generic licensing.
There have been two 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 three 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: | 45 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 45 |
Clinical Trials: | 6 |
Patent Applications: | 360 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NUCYNTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NUCYNTA |
What excipients (inactive ingredients) are in NUCYNTA? | NUCYNTA excipients list |
DailyMed Link: | NUCYNTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NUCYNTA
Generic Entry Dates for NUCYNTA*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION NDA:
Dosage:
SOLUTION;ORAL |
Generic Entry Dates for NUCYNTA*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION 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 |
Anatomical Therapeutic Chemical (ATC) Classes for NUCYNTA
Paragraph IV (Patent) Challenges for NUCYNTA
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 |
US Patents and Regulatory Information for NUCYNTA
NUCYNTA is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUCYNTA is ⤷ Try a Trial.
This potential generic entry date is based on NEW PATIENT POPULATION.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting NUCYNTA
Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN
Crystalline forms of (-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: RELIEF OF MODERATE TO SEVERE ACUTE PAIN
FDA Regulatory Exclusivity protecting NUCYNTA
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | SOLUTION;ORAL | 203794-001 | Oct 15, 2012 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | SOLUTION;ORAL | 203794-001 | Oct 15, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NUCYNTA
When does loss-of-exclusivity occur for NUCYNTA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 9949
Estimated Expiration: ⤷ Try a Trial
Patent: 6052
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 05256512
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 68639
Estimated Expiration: ⤷ Try a Trial
Patent: 96021
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0512792
Estimated Expiration: ⤷ Try a Trial
Patent: 2018014454
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 72147
Estimated Expiration: ⤷ Try a Trial
China
Patent: 97621
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0110050
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 06929
Estimated Expiration: ⤷ Try a Trial
Patent: 11530
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 12203
Estimated Expiration: ⤷ Try a Trial
Patent: 99633
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 17046065
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 12203
Estimated Expiration: ⤷ Try a Trial
Patent: 99633
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2004007905
Estimated Expiration: ⤷ Try a Trial
Patent: 2005026031
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 0373
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 90764
Estimated Expiration: ⤷ Try a Trial
Patent: 08504326
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 06014741
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 1605
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 8605
Estimated Expiration: ⤷ Try a Trial
Patent: 1239
Estimated Expiration: ⤷ Try a Trial
Patent: 3922
Estimated Expiration: ⤷ Try a Trial
Patent: 070162
Estimated Expiration: ⤷ Try a Trial
Patent: 160914
Estimated Expiration: ⤷ Try a Trial
Patent: 171103
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 060372
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 12203
Estimated Expiration: ⤷ Try a Trial
Patent: 99633
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 12203
Estimated Expiration: ⤷ Try a Trial
Patent: 99633
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 23345
Estimated Expiration: ⤷ Try a Trial
Patent: 07103297
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 12203
Estimated Expiration: ⤷ Try a Trial
Patent: 99633
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0700774
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1096501
Estimated Expiration: ⤷ Try a Trial
Patent: 070039929
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 91780
Estimated Expiration: ⤷ Try a Trial
Patent: 59504
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering NUCYNTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 309734 | ⤷ Try a Trial | |
Czech Republic | 9501904 | ⤷ Try a Trial | |
Brazil | 9609019 | ⤷ Try a Trial | |
Austria | 346595 | ⤷ Try a Trial | |
Japan | 2008504326 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NUCYNTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0693475 | CR 2010 00036 | Denmark | ⤷ Try a 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 | 1190004-0.L | Sweden | ⤷ Try a 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 | CA 2010 00036 | Denmark | ⤷ Try a Trial | |
1439829 | C 2011 002 | Romania | ⤷ Try a Trial | 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 |
0693475 | 12C0016 | France | ⤷ Try a Trial | PRODUCT NAME: TAPENTADOL SOUS FORME DE SA BASE LIBRE OU SOUS FORME D'UN DE SES SELS D'ACIDES ACCEPTABLES DU POINT DE VUE PHYSIOLOGIQUE; NAT. REGISTRATION NO/DATE: NL40884 20111003; FIRST REGISTRATION: DE - 76261.00.00 20100819 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |