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
*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 ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: RELIEF OF MODERATE TO SEVERE ACUTE PAIN
FDA Regulatory Exclusivity protecting NUCYNTA
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-002 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Patent: 6052
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 05256512
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 68639
Estimated Expiration: ⤷ Sign Up
Patent: 96021
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0512792
Estimated Expiration: ⤷ Sign Up
Patent: 2018014454
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 72147
Estimated Expiration: ⤷ Sign Up
China
Patent: 97621
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0110050
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 06929
Estimated Expiration: ⤷ Sign Up
Patent: 11530
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 12203
Estimated Expiration: ⤷ Sign Up
Patent: 99633
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 17046065
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 12203
Estimated Expiration: ⤷ Sign Up
Patent: 99633
Estimated Expiration: ⤷ Sign Up
Germany
Patent: 2004007905
Estimated Expiration: ⤷ Sign Up
Patent: 2005026031
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 0373
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 90764
Estimated Expiration: ⤷ Sign Up
Patent: 08504326
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 06014741
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 1605
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 8605
Estimated Expiration: ⤷ Sign Up
Patent: 1239
Estimated Expiration: ⤷ Sign Up
Patent: 3922
Estimated Expiration: ⤷ Sign Up
Patent: 070162
Estimated Expiration: ⤷ Sign Up
Patent: 160914
Estimated Expiration: ⤷ Sign Up
Patent: 171103
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 060372
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 12203
Estimated Expiration: ⤷ Sign Up
Patent: 99633
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 12203
Estimated Expiration: ⤷ Sign Up
Patent: 99633
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 23345
Estimated Expiration: ⤷ Sign Up
Patent: 07103297
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 12203
Estimated Expiration: ⤷ Sign Up
Patent: 99633
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0700774
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1096501
Estimated Expiration: ⤷ Sign Up
Patent: 070039929
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 91780
Estimated Expiration: ⤷ Sign Up
Patent: 59504
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| South Africa | 9506118 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2006000441 | ⤷ Sign Up | |
| Denmark | 0743853 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NUCYNTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0693475 | 12C0016 | France | ⤷ Sign Up | 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 |
| 0693475 | 1190004-0.L | Sweden | ⤷ Sign Up | 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 | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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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