Generated: December 15, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 204384
« Back to Dashboard
, 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
|Formulation / Manufacturing:||see details|
Pharmacology for NDA: 204384
Suppliers and Packaging for NDA: 204384
||National Drug Code
||Janssen Products, LP
||188 TABLET in 1 BOTTLE (59676-701-01)
|Complete Access Available with Subscription
Summary for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||TABLET;ORAL||Strength||EQ 100MG BASE|
|Approval Date:||Dec 28, 2012||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Dec 28, 2017
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||Dec 28, 2019
|Regulatory Exclusivity Use:||ORPHAN DRUG EXCLUSIVITY|
|Patent:||► Subscribe||Patent Expiration:||Oct 2, 2024||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
Serving leading biopharmaceutical companies globally:
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 verifification 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.