Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

Tapentadol hydrochloride - Generic Drug Details

« Back to Dashboard

What are the generic drug sources, and freedom to operate, for tapentadol hydrochloride?

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 fifty-five 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 / Packagers: see list7
Bulk Api Vendors: see list24
Clinical Trials: see list1,001
Patent Applications: see list139
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-001Aug 25, 2011RXYesNo8,114,383► SubscribeYY ► Subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-001Aug 25, 2011RXYesNo8,536,130► Subscribe ► Subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-003Aug 25, 2011RXYesNo8,114,383► SubscribeYY ► Subscribe
Depomed Inc
NUCYNTA ER
tapentadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL200533-005Aug 25, 2011RXYesYes8,075,872► SubscribeY ► Subscribe
Depomed Inc
NUCYNTA
tapentadol hydrochloride
TABLET;ORAL022304-002Nov 20, 2008RXYesNo6,071,970► Subscribe ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
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
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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: tapentadol hydrochloride

Country Document Number Estimated Expiration
Russian Federation2423345► Subscribe
Germany502004010368► Subscribe
Japan2010520907► Subscribe
World Intellectual Property Organization (WIPO)2008110323► Subscribe
Denmark0831799► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: TAPENTADOL HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011007Lithuania► SubscribePRODUCT NAME: TAPENTADOLUM; NAT. REGISTRATION NO/DATE: LT/1/10/2341/001 - LT/1/10/2341/66, 2011 02 19; LT/1/10/2342/001 - LT/1/10/2342/110 20110219; FIRST REGISTRATION: 75043.00.00 - 75048.00.00, 2010 08 19; 76261.00.00 - 76270.00.00 20100819
90004-0.LSweden► SubscribePRODUCT NAME: TAPENTADOL; NAT. REG. NO/DATE: 42622-42628 20100910; FIRST REG.: DE 7543-7548,7661-76270" EESGODKLANDKOD="DE" EESGODKDATUM="2010-08-19" SEGODKNR="42622-42628 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
2010 00036Denmark► Subscribe
0693475/01Switzerland► SubscribePRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

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.

`abc