Details for New Drug Application (NDA): 202022

✉ Email this page to a colleague

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 are three patents 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. One supplier is 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:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 202022

Generic Entry Date for 202022^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 7,125,879PED 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.

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:		RLD:	Yes
Patent:	7,125,879*PED	Patent Expiration:	Oct 21, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 202022

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	8,101,629	⤷ Subscribe
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	6,838,464	⤷ Subscribe
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	8,080,551	⤷ Subscribe
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	7,638,522	⤷ Subscribe
Janssen Prods	EDURANT	rilpivirine hydrochloride	TABLET;ORAL	202022-001	May 20, 2011	7,067,522	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.