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Last Updated: February 25, 2021

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Details for New Drug Application (NDA): 203794

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NDA 203794 describes NUCYNTA, which is a drug marketed by Collegium Pharm Inc and is included in three NDAs. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for 203794
Tradename:NUCYNTA
Applicant:Collegium Pharm Inc
Ingredient:tapentadol hydrochloride
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 203794
Generic Entry Date for 203794*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Paragraph IV (Patent) Challenges for 203794
Tradename Dosage Ingredient NDA Submissiondate
NUCYNTA SOLUTION;ORAL tapentadol hydrochloride 203794 2013-12-20

Profile for product number 001

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

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