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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 202022

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NDA 202022 describes EDURANT, which is a drug marketed by Janssen Prods and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the EDURANT profile page.

The generic ingredient in EDURANT is rilpivirine hydrochloride. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.

Summary for 202022

Tradename:	EDURANT
Applicant:	Janssen Prods
Ingredient:	rilpivirine hydrochloride
Patents:	0

Pharmacology for NDA: 202022

Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 202022

Anti-HIV Agents
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 202022

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022	NDA	Janssen Products, LP	59676-278	59676-278-01	30 TABLET, FILM COATED in 1 BOTTLE (59676-278-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	May 20, 2011	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 15, 2027
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Sep 15, 2027
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 202022

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	⤷ Start Trial	⤷ Start Trial
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	⤷ Start Trial	⤷ Start Trial
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	⤷ Start Trial	⤷ Start Trial
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	⤷ Start Trial	⤷ Start Trial
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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