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Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205353

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NDA 205353 describes FARYDAK, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the FARYDAK profile page.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the panobinostat lactate profile page.
Summary for 205353
Tradename:FARYDAK
Applicant:Novartis Pharms Corp
Ingredient:panobinostat lactate
Patents:5
Generic Entry Opportunity Date for 205353
Generic Entry Date for 205353*:
Constraining patent/regulatory exclusivity:
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: 205353
Suppliers and Packaging for NDA: 205353
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FARYDAK panobinostat lactate CAPSULE;ORAL 205353 NDA Novartis Pharmaceuticals Corporation 0078-0650 0078-0650-06 6 CAPSULE in 1 BLISTER PACK (0078-0650-06)
FARYDAK panobinostat lactate CAPSULE;ORAL 205353 NDA Novartis Pharmaceuticals Corporation 0078-0651 0078-0651-06 6 CAPSULE in 1 BLISTER PACK (0078-0651-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Feb 23, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 23, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 23, 2022
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 2 PRIOR REGIMENS, INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT
Patent:➤ Try a Free TrialPatent Expiration:Aug 31, 2021Product Flag?YSubstance Flag?YDelist Request?

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