Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Farmers Insurance
Boehringer Ingelheim
Baxter
QuintilesIMS
Cantor Fitzgerald
Argus Health
Mallinckrodt
Teva

Generated: January 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200533

« Back to Dashboard

NDA 200533 describes NUCYNTA ER, which is a drug marketed by Depo Nf 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. Four suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for 200533
Tradename:NUCYNTA ER
Applicant:Depo Nf
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 Janssen Pharmaceuticals, Inc. 50458-860 50458-860-01 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-860-01)
NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533 NDA Janssen Pharmaceuticals, Inc. 50458-860 50458-860-02 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-860-02) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:Aug 25, 2011TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
Patent:➤ Sign UpPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
Patent:➤ Sign UpPatent 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
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 ➤ Sign Up ➤ Sign Up
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 ➤ Sign Up ➤ Sign Up
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 ➤ Sign Up ➤ Sign Up
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, 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:

Moodys
UBS
Federal Trade Commission
Fish and Richardson
QuintilesIMS
AstraZeneca
Fuji
Farmers Insurance
Boehringer Ingelheim

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.