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NUCYNTA Drug Profile

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Nucynta is a drug marketed by Depomed Inc and is included in three NDAs. It is available from seven suppliers. There are eight patents protecting this drug and four Paragraph IV challenges.

This drug has one hundred and seventeen patent family members in thirty-three countries.

The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.

Summary for Tradename: NUCYNTA

Patents:8
Applicants:1
NDAs:3
Suppliers / Packagers: see list7
Bulk Api Vendors: see list22
Clinical Trials: see list5
Patent Applications: see list139
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:NUCYNTA at DailyMed

Pharmacology for Tradename: NUCYNTA

Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-005Aug 25, 2011RXYesYes8,075,872► subscribeY ► subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-003Aug 25, 2011RXYesNo8,309,060► subscribeY ► subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-004Aug 25, 2011RXYesNo6,071,970► subscribe ► subscribe
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Paragraph IV activity for: NUCYNTA

Drugname Dosage Strength RLD Submissiondate
tapentadol hydrochlorideTabletsx50 mg, 75 mg, and 100 mgNucynta11/20/2012
tapentadol hydrochlorideExtended-release Tablets50 mg, 100 mg, 150 mg, 200 mg, and 250 mgNucynta ER11/20/2012
tapentadolOral Solution20 mg/mLNucynta12/20/2013
tapentadolOral Solution20 mg/mLNucynta12/30/2013

Non-Orange Book Patents for Tradename: NUCYNTA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,017,965 Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases► subscribe
6,306,912 Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases► subscribe
6,344,558 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effect► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: NUCYNTA

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9746511► subscribe
Germany69434889► subscribe
Canada2154424► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: NUCYNTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010 00036Denmark► subscribePRODUCT 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
00541Netherlands► subscribePRODUCT 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
C/GB11/031United Kingdom► subscribePRODUCT 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
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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 verifification 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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