NUCYNTA ER Drug Patent Profile
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Which patents cover Nucynta Er, and what generic alternatives are available?
Nucynta Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and seventy-two patent family members in thirty-one countries.
The generic ingredient in NUCYNTA ER 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 Er
Nucynta Er 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 eighteen 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 ER
| International Patents: | 272 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| 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 ER |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NUCYNTA ER |
| DailyMed Link: | NUCYNTA ER at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NUCYNTA ER
*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 ER
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 ER
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for NUCYNTA ER
Paragraph IV (Patent) Challenges for NUCYNTA ER
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NUCYNTA ER | Extended-release Tablets | tapentadol hydrochloride | 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg | 200533 | 2 | 2012-11-20 |
US Patents and Regulatory Information for NUCYNTA ER
NUCYNTA ER is protected by six US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUCYNTA ER is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ 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.
Patents protecting NUCYNTA ER
Titration of tapentadol
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TITRATING AN OPIOID TO MANAGE PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
Titration of tapentadol
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TITRATING AN OPIOID TO MANAGE NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
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 NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
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 CHRONIC PAIN
Abuse-proofed dosage form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
| 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 | 200533-005 | Aug 25, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Collegium Pharm 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 |
Expired US Patents for NUCYNTA ER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NUCYNTA ER
When does loss-of-exclusivity occur for NUCYNTA ER?
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 ER around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2359504 | ⤷ Sign Up | |
| Russian Federation | 2201224 | COMPOUNDS ACTIVE IN NOVEL SITE ON RECEPTOR-REGULATING CALCIUM CHANNELS AND USED FOR TREATMENT OF NEUROLOGICAL DISTURBANCES AND DISEASES | ⤷ Sign Up |
| Germany | 502004010368 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NUCYNTA ER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1439829 | C20110003 00036 | Estonia | ⤷ Sign Up | PRODUCT NAME: PALEXIA; REG NO/DATE: RR-4/42 22.10.2010 |
| 0693475 | SPC/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 |
| 0693475 | PA2011007,C0693475 | 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 |
| >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.
ISSN: 2162-2639
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