Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

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. There is one drug master file entry for this compound. 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
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:Aug 9, 2026
Regulatory Exclusivity Use:INDICATED AS PART OF COMBINATION THERAPY IN THE TREATMENT OF PEDIATRIC PATIENTS (12 TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 30 KG) WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS
Regulatory Exclusivity Expiration:Aug 9, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION
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)

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