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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204684

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NDA 204684 describes IMPAVIDO, which is a drug marketed by Knight Theraps and is included in one NDA. It is available from one supplier. Additional details are available on the IMPAVIDO profile page.

The generic ingredient in IMPAVIDO is miltefosine. One supplier is listed for this compound. Additional details are available on the miltefosine profile page.
Summary for 204684
Tradename:IMPAVIDO
Applicant:Knight Theraps
Ingredient:miltefosine
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204684
Generic Entry Date for 204684*:
Constraining patent/regulatory exclusivity:
TREATMENT OF VISCERAL LEISHMANIASIS DUE TO LEISHMANIA DONOVANI; CUTANEOUS LEISHMANIASIS DUE TO LEISHMANIA BRAZILIENSIS, LEISHMANIA GUYANENSIS, AND LEISHMANIA PANAMENSIS; AND MUCOSAL LEISHMANIASIS DUE TO LEISHMANIA BRAZILIENSIS.
Dosage:
CAPSULE;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: 204684
Suppliers and Packaging for NDA: 204684
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMPAVIDO miltefosine CAPSULE;ORAL 204684 NDA Profounda, Inc. 69051-300 69051-300-01 2 BLISTER PACK in 1 CARTON (69051-300-01) > 14 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Mar 19, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Mar 19, 2021
Regulatory Exclusivity Use:TREATMENT OF VISCERAL LEISHMANIASIS DUE TO LEISHMANIA DONOVANI; CUTANEOUS LEISHMANIASIS DUE TO LEISHMANIA BRAZILIENSIS, LEISHMANIA GUYANENSIS, AND LEISHMANIA PANAMENSIS; AND MUCOSAL LEISHMANIASIS DUE TO LEISHMANIA BRAZILIENSIS.

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Queensland Health
US Army
UBS
Cerilliant
Boehringer Ingelheim
Chubb
Federal Trade Commission
AstraZeneca

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