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Fuji
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Federal Trade Commission
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203794

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NDA 203794 describes NUCYNTA, which is a drug marketed by Depomed Inc and is included in three NDAs. It is available from six suppliers. There are seven 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. Six suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for 203794
Tradename:NUCYNTA
Applicant:Depomed Inc
Ingredient:tapentadol hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 203794
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 203794
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794 NDA Janssen Pharmaceuticals, Inc. 50458-817 N 50458-817-02
NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794 NDA Janssen Pharmaceuticals, Inc. 50458-817 N 50458-817-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 20MG BASE/ML
Approval Date:Oct 15, 2012TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN
Patent:➤ Sign UpPatent Expiration:Aug 5, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN

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Boehringer Ingelheim
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