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. There are two 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. 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. Additional details are available on the panobinostat lactate profile page.
Summary for 205353
| Tradename: | FARYDAK |
| Applicant: | Secura |
| Ingredient: | panobinostat lactate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Feb 23, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 17, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 13, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 15MG BASE | ||||
| Approval Date: | Feb 23, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 17, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 205353
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-002 | Feb 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-002 | Feb 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-003 | Feb 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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