Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022304

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NDA 022304 describes NUCYNTA, which is a drug marketed by Assertio and Depo Nf and is included in three NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for 022304
Tradename:NUCYNTA
Applicant:Depo Nf
Ingredient:tapentadol hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022304
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 022304
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304 NDA Collegium Pharmaceutical, Inc. 24510-050 24510-050-01 10 BLISTER PACK in 1 CARTON (24510-050-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK
NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304 NDA Collegium Pharmaceutical, Inc. 24510-050 24510-050-10 100 TABLET, FILM COATED in 1 BOTTLE (24510-050-10)
Paragraph IV (Patent) Challenges for 022304
Tradename Dosage Ingredient NDA Submissiondate
NUCYNTA TABLET;ORAL tapentadol hydrochloride 022304 2012-11-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Nov 20, 2008TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN
Patent:  Start TrialPatent Expiration:Aug 5, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Nov 20, 2008TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN

Expired US Patents for NDA 022304

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008   Start Trial   Start Trial
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008   Start Trial   Start Trial
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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