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NUCYNTA ER Drug Profile

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Nucynta Er is a drug marketed by Depomed Inc and is included in one NDA. It is available from two suppliers. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-nine patent family members in thirty-six countries.

The generic ingredient in NUCYNTA ER 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 ER

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: NUCYNTA ER

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;ORAL200533-004Aug 25, 2011RXNo8,420,056► subscribeY ► subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-004Aug 25, 2011RXNo8,075,872► subscribeY ► subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-005Aug 25, 2011RXYes7,994,364► subscribeYY ► subscribe
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Paragraph IV activity for: NUCYNTA ER

Drugname Dosage Strength RLD Submissiondate
tapentadol hydrochlorideExtended-release Tablets50 mg, 100 mg, 150 mg, 200 mg, and 250 mgNucynta ER11/20/2012

Non-Orange Book Patents for Tradename: NUCYNTA ER

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
6,750,244 Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases► subscribe
8,323,889Process for the production of an abuse-proofed solid dosage form► 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 ER

Country Document Number Estimated Expiration
Japan2010520907► subscribe
Peru03532005► subscribe
Portugal1612203► 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 ER

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475/01Switzerland► subscribePRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
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
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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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