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

Serving leading biopharmaceutical companies globally:

Teva
Harvard Business School
Argus Health
McKesson
Merck
Mallinckrodt
AstraZeneca
Fuji
UBS
QuintilesIMS

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022304

« Back to Dashboard

NDA 022304 describes NUCYNTA, which is a drug marketed by Depomed Inc and is included in three NDAs. It is available from eight suppliers. There are eight patents protecting this drug and four Paragraph IV challenges. Additional details are available on the NUCYNTA profile page.

The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.

Summary for 022304

Tradename:1
Applicant:1
Ingredient:1
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 022304

Mechanism of ActionOpioid Agonists

Suppliers and Packaging for NDA: 022304

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304 NDA Stat Rx USA 16590-289 16590-289-60 60 TABLET, FILM COATED in 1 BOTTLE (16590-289-60)
NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304 NDA Stat Rx USA 16590-863 16590-863-60 60 TABLET, FILM COATED in 1 BOTTLE (16590-863-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Nov 20, 2008TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jun 6, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN
Patent:► SubscribePatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN
Patent:► SubscribePatent Expiration:Aug 5, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN

Expired Orange Book Patents for NDA: 022304

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed IncNUCYNTAtapentadol hydrochlorideTABLET;ORAL022304-003Nov 20, 2008► Subscribe► Subscribe
Depomed IncNUCYNTAtapentadol hydrochlorideTABLET;ORAL022304-001Nov 20, 2008► Subscribe► Subscribe
Depomed IncNUCYNTAtapentadol hydrochlorideTABLET;ORAL022304-002Nov 20, 2008► 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.



Complete Access Available with Subscription
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Cerilliant
Teva
McKesson
US Department of Justice
US Army
UBS
Johnson and Johnson
Argus Health
Federal Trade Commission
Julphar

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot