Details for New Drug Application (NDA): 219016

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NDA 219016 describes EDURANT PED, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the EDURANT PED profile page.

The generic ingredient in EDURANT PED 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 219016

Tradename:	EDURANT PED
Applicant:	Janssen Prods
Ingredient:	rilpivirine hydrochloride
Patents:	1

Pharmacology for NDA: 219016

Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 219016

Anti-HIV Agents
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 219016

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016	NDA	Janssen Products, LP	59676-280	59676-280-90	9 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Mar 15, 2024	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 15, 2027
Regulatory Exclusivity Use:	NEW PRODUCT
Regulatory Exclusivity Expiration:	Sep 15, 2027
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	⤷ Get Started Free	Patent Expiration:	Oct 23, 2037	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 219016

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	EDURANT PED	rilpivirine hydrochloride	TABLET, FOR SUSPENSION;ORAL	219016-001	Mar 15, 2024	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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