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Details for New Drug Application (NDA): 205353
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NDA 205353 describes FARYDAK, which is a drug marketed by Secura 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.
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: | Secura |
| 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
| Mechanism of Action | Histone Deacetylase Inhibitors Cytochrome P450 2D6 Inhibitors |
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: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Feb 23, 2015 | TE: | 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: | Start Trial | Patent Expiration: | Aug 31, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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