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Last Updated: July 4, 2020

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Details for New Drug Application (NDA): 202276


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NDA 202276 describes STENDRA, which is a drug marketed by Metuchen Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the STENDRA profile page.

The generic ingredient in STENDRA is avanafil. There are five drug master file entries for this compound. Additional details are available on the avanafil profile page.
Summary for 202276
Tradename:STENDRA
Applicant:Metuchen Pharms
Ingredient:avanafil
Patents:2
Generic Entry Opportunity Date for 202276
Generic Entry Date for 202276*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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 202276
Tradename Dosage Ingredient NDA Submissiondate
STENDRA TABLET;ORAL avanafil 202276 2016-04-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Apr 27, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ERECTILE DYSFUNCTION
Patent:  Start TrialPatent Expiration:May 5, 2023Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Apr 27, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ERECTILE DYSFUNCTION

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