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Generated: April 23, 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 four 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. Four 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 Action	Opioid 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	50458-817-01
NUCYNTA	tapentadol hydrochloride	SOLUTION;ORAL	203794	NDA	Janssen Pharmaceuticals, Inc.	50458-817	N	50458-817-02

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 20MG BASE/ML
Approval Date:	Oct 15, 2012	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Jun 27, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN
Patent:	➤ Try a Free Trial	Patent Expiration:	Aug 5, 2022	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN

Expired US Patents for NDA 203794

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Depomed Inc	NUCYNTA	tapentadol hydrochloride	SOLUTION;ORAL	203794-001	Oct 15, 2012	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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