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Last Updated: October 15, 2019

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Details for New Drug Application (NDA): 200533

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NDA 200533 describes NUCYNTA ER, which is a drug marketed by Depo Nf and is included in one NDA. It is available from five 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. Five 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 Collegium Pharmaceutical, Inc. 24510-058 24510-058-01 10 BLISTER PACK in 1 CARTON (24510-058-01) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533 NDA Collegium Pharmaceutical, Inc. 24510-058 24510-058-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24510-058-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:Aug 25, 2011TE:RLD:Yes
Patent:  See PricingPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
Patent:  See PricingPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
Patent:  See PricingPatent 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 200533-004 Aug 25, 2011   See Pricing   See Pricing
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011   See Pricing   See Pricing
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011   See Pricing   See Pricing
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011   See Pricing   See Pricing
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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