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Baxter
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Healthtrust
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Generated: August 20, 2017

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Tapentadol hydrochloride - Generic Drug Details

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What are the generic sources for tapentadol hydrochloride and what is the scope of tapentadol hydrochloride patent protection?

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.

Tapentadol hydrochloride has two hundred and sixty-one patent family members in thirty-seven countries.

There are five drug master file entries for tapentadol hydrochloride. Eight 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 list5
Suppliers / Packagers: see list8
Bulk Api Vendors: see list24
Clinical Trials: see list2,311
Patent Applications: see list218
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tapentadol hydrochloride at DailyMed

Pharmacology for Ingredient: tapentadol hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE 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, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-004Aug 25, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-002Aug 25, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-001Aug 25, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-001Aug 25, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tapentadol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-003Aug 25, 2011► Subscribe► Subscribe
Depomed Inc
NUCYNTA
tapentadol hydrochloride
TABLET;ORAL022304-001Nov 20, 2008► Subscribe► Subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-004Aug 25, 2011► Subscribe► Subscribe
Depomed Inc
NUCYNTA
tapentadol hydrochloride
TABLET;ORAL022304-003Nov 20, 2008► Subscribe► Subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-005Aug 25, 2011► 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
6,306,912 Compounds 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
6,750,244 Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases► Subscribe
6,017,965 Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases► Subscribe
7,268,166Compounds 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
World Intellectual Property Organization (WIPO)9856752► Subscribe
Norway20160914► Subscribe
Japan2007533692► Subscribe
Spain2285497► Subscribe
Slovenia1799633► 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► 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
0693475/01Switzerland► SubscribePRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
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
793Luxembourg► Subscribe91793, EXPIRES: 20200712
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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
Merck
Dow
Covington
Mallinckrodt
McKinsey
QuintilesIMS
Fuji
Teva

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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