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.
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Dec 28, 2012 | TE: | 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: | May 27, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED AS PART OF COMBINATION THERAPY IN THE TREATMENT OF PEDIATRIC PATIENTS 5 YEARS AND OLDER TO LESS THAN 12 YEARS OF AGE AND WEIGHING AT LEAST 15 KG WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS (MDR-TB) | ||||||||
| Regulatory Exclusivity Expiration: | Jun 21, 2027 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF A CLINICAL STUDY TO FULFILL POST MARKETING REQUIREMENT 1988-001 | ||||||||
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