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Generated: November 17, 2018

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Details for New Drug Application (NDA): 022187

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NDA 022187 describes INTELENCE, which is a drug marketed by Janssen R And D and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the INTELENCE profile page.

The generic ingredient in INTELENCE is etravirine. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the etravirine profile page.
Summary for 022187
Tradename:INTELENCE
Applicant:Janssen R And D
Ingredient:etravirine
Patents:4
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022187
Generic Entry Date for 022187*:
Constraining patent/regulatory exclusivity:
PEDIATRIC 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.

Pharmacology for NDA: 022187
Suppliers and Packaging for NDA: 022187
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INTELENCE etravirine TABLET;ORAL 022187 NDA State of Florida DOH Central Pharmacy 53808-0787 53808-0787-1 30 TABLET in 1 BLISTER PACK (53808-0787-1)
INTELENCE etravirine TABLET;ORAL 022187 NDA Janssen Products LP 59676-570 59676-570-01 120 TABLET in 1 BOTTLE, PLASTIC (59676-570-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 18, 2008TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 16, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jan 16, 2022
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Try a Free TrialPatent Expiration:May 5, 2020Product Flag?Substance Flag?Delist Request?Y

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