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Tapentadol hydrochloride - Generic Drug Details

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Tapentadol hydrochloride is the generic ingredient in two branded drugs marketed by Depomed Inc and is included in three NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are four drug master file entries for tapentadol hydrochloride. Seven suppliers are listed for this compound.

Summary for Generic Name: tapentadol hydrochloride

Tradenames:2
Patents:8
Applicants:1
NDAs:3
Drug Master File Entries: see list4
Suppliers / Packaging: see list7
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: tapentadol hydrochloride

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;ORAL200533-001Aug 25, 2011RXNo8,420,056► subscribeY ► subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-002Aug 25, 2011RXNo► subscribe► subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-004Aug 25, 2011RXNo6,071,970► subscribe ► subscribe
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Non-Orange Book Patents for Generic Ingredient: tapentadol hydrochloride

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
6,051,610 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
7,087,765Compounds 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 Ingredient: tapentadol hydrochloride

Country Document Number Estimated Expiration
South Korea20120104199► subscribe
Russian Federation2339365► subscribe
Germany69427168► 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: TAPENTADOL HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010 00036Denmark► subscribe
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
C0016France► subscribePRODUCT 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
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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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