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Generic Farydak Availability

Farydak is a brand name of panobinostat, approved by the FDA in the following formulation(s):

FARYDAK (panobinostat lactate - capsule;oral)

  • Manufacturer: NOVARTIS PHARMS CORP
    Approval date: February 23, 2015
    Strength(s): EQ 10MG BASE, EQ 15MG BASE, EQ 20MG BASE [RLD]

Has a generic version of Farydak been approved?

No. There is currently no therapeutically equivalent version of Farydak available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Farydak. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Deacetylase inhibitors
    Patent 6,552,065
    Issued: April 22, 2003
    Inventor(s): Stacy William; Remiszewski & Kenneth Walter; Bair & Richard William; Versace & Lawrence Blas; Perez & Michael Alan; Green & Lidia Cristina; Sambucetti & Sushil; Sharma
    Assignee(s): Novartis AG
    The present invention provides hydroxamate compounds which are deacetylase inhibitors. The compounds are suitable for pharmaceutical compositions having anti-proliferative properties.
    Patent expiration dates:
    • August 31, 2021
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  • Deacetylase inhibitors
    Patent 6,833,384
    Issued: December 21, 2004
    Inventor(s): Stacy William; Remiszewski & Kenneth Walter; Bair & Richard William; Versace & Lawrence Blas; Perez & Michael Alan; Green & Lidia Cristina; Sambucetti & Sushil; Sharma
    Assignee(s): Novartis AG
    The present invention provides hydroxamate compounds which are deacetylase inhibitors. The compounds are suitable for pharmaceutical compositions having anti-proliferative properties.
    Patent expiration dates:
    • September 30, 2021
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      Patent use: TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE
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  • Deacetylase inhibitors
    Patent 7,067,551
    Issued: June 27, 2006
    Inventor(s): Remiszewski; Stacy W & Bair; Kenneth W & Versace; Richard W & Perez; Lawrence B & Green; Michael A & Sambucetti; Lidia C & Sharma; Sushil
    Assignee(s): Novartis AG
    The present invention provides hydroxamate compounds which are deacetylase inhibitors. The compounds are suitable for pharmaceutical compositions having anti-proliferative properties.
    Patent expiration dates:
    • August 31, 2021
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      Patent use: TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE
  • Polymorphs of N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2E-2-propenamide
    Patent 7,989,494
    Issued: August 2, 2011
    Inventor(s): Acemoglu; Murat & Bajwa; Joginder S. & Karpinski; Piotr & Papoutsakis; Dimitris & Slade; Joel & Stowasser; Frank
    Assignee(s): Novartis AG
    Polymorphic forms of N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2E-2-propenamide free base and salts thereof are prepared by various processes.
    Patent expiration dates:
    • January 17, 2028
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  • Use of HDAC inhibitors for the treatment of myeloma
    Patent 8,883,842
    Issued: November 11, 2014
    Assignee(s): Novartis AG
    The present invention relates to the use of an HDAC inhibitor, especially an HDAC inhibitor of formula (I) wherein the radicals and symbols have the meanings as defined in the specification, for the preparation of a medicament for the treatment of myeloma, in particular, multiple myeloma, especially myeloma which is resistant to conventional chemotherapy; to a combination comprising an HDAC inhibitor and a compound effecting apoptosis of myeloma cells, preferably bortezomib, for simultaneous, separate or sequential use; to methods of treating myeloma; and to a pharmaceutical composition comprising said combination.
    Patent expiration dates:
    • June 13, 2028
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      Patent use: TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • February 23, 2020 - NEW CHEMICAL ENTITY
    • February 23, 2022 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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