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Last Updated: July 3, 2020

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)
SIRTURO bedaquiline fumarate TABLET;ORAL 204384 NDA Janssen Products, LP 59676-702 59676-702-60 60 TABLET in 1 BOTTLE (59676-702-60)

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
Patent:  Start TrialPatent Expiration:Dec 1, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS

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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.