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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
Drug Prices: :see details

Pharmacology for Tradename: NUCYNTA

Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-003Aug 25, 2011RXNo7,994,364► subscribeYY ► subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-002Aug 25, 2011RXNoRE39593► subscribeYY ► subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-003Aug 25, 2011RXNo8,420,056► subscribeY ► 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
7,268,166Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases► subscribe
6,248,737 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects► subscribe
6,017,965 Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases► 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
Portugal831799► subscribe
European Patent Office1749522► subscribe
Slovenia1612203► 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
11/010Ireland► subscribePRODUCT 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
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
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