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Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204384

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NDA 204384 describes SIRTURO, which is a drug marketed by Janssen Therap and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SIRTURO profile page.

The generic ingredient in SIRTURO is bedaquiline fumarate. One supplier is listed for this compound. Additional details are available on the bedaquiline fumarate profile page.
Summary for 204384
Tradename:SIRTURO
Applicant:Janssen Therap
Ingredient:bedaquiline fumarate
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204384
Generic Entry Date for 204384*:
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.

Pharmacology for NDA: 204384
Ingredient-typeDiarylquinolines
Suppliers and Packaging for NDA: 204384
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIRTURO bedaquiline fumarate TABLET;ORAL 204384 NDA Janssen Products, LP 59676-701 59676-701-01 188 TABLET in 1 BOTTLE (59676-701-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Dec 28, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 28, 2019
Regulatory Exclusivity Use:PART OF COMBINATION THERAPY IN ADULTS (GREATER THAN OR EQUAL TO 18 YEARS) WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS (MDR-TB)
Patent:➤ Try a Free TrialPatent Expiration:Oct 2, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Dec 1, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS

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