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

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
US Army
Covington
Deloitte
Healthtrust
Teva
Baxter
Julphar
Cantor Fitzgerald

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200533

« Back to Dashboard

NDA 200533 describes NUCYNTA ER, which is a drug marketed by Depomed Inc and is included in one NDA. It is available from three suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NUCYNTA ER profile page.

The generic ingredient in NUCYNTA ER is tapentadol hydrochloride. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for 200533
Tradename:NUCYNTA ER
Applicant:Depomed Inc
Ingredient:tapentadol hydrochloride
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 200533
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 200533
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533 NDA Lake Erie Medical DBA Quality Care Products LLC 35356-770 N 35356-770-60
NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533 NDA Lake Erie Medical DBA Quality Care Products LLC 35356-810 N 35356-810-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:Aug 25, 2011TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
Patent:➤ Try a Free TrialPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
Patent:➤ Try a Free TrialPatent Expiration:Nov 20, 2023Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 200533

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Cipla
US Department of Justice
QuintilesIMS
Accenture
Harvard Business School
Argus Health
Covington

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.