Generic Zolinza Availability

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

ZOLINZA (vorinostat - capsule;oral)

  • Manufacturer: MERCK
    Approval date: October 6, 2006
    Strength(s): 100MG [RLD]

Has a generic version of Zolinza been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zolinza. 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.

  • Methods of treating cancer with HDAC inhibitors
    Patent 7,399,787
    Issued: July 15, 2008
    Inventor(s): Chiao; Judy H. & Bacopoulos; Nicholas G. & Miller; Thomas A. & Paradise; Carolyn M. & Richon; Victoria M.
    Assignee(s): Merck HDAC Research, LLC
    The present invention provides methods of treating cancers, chemoprevention, selectively inducing terminal differentiation, cell growth arrest and/or apoptosis of neoplastic cells, and/or inhibiting histone deacetylase (HDAC) by administration of pharmaceutical compositions comprising potent HDAC inhibitors. The oral bioavailability of the active compounds in the pharmaceutical compositions of the present invention is surprisingly high. Moreover, the pharmaceutical compositions unexpectedly give rise to high, therapeutically effective blood levels of the active compounds over an extended period of time. The present invention further provides a safe, daily dosing regimen of these pharmaceutical compositions, which is easy to follow, and which results in a therapeutically effective amount of the HDAC inhibitors in vivo.
    Patent expiration dates:
    • February 9, 2025
      ✓ 
      Patent use: TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA (CTCL)
  • Polymorphs of suberoylanilide hydroxamic acid
    Patent 7,456,219
    Issued: November 25, 2008
    Inventor(s): Miller; Thomas A. & Richon; Victoria M. & Chiao; Judy H.
    Assignee(s): Merck HDAC Research, LLC
    The present invention provides methods of selectively inducing terminal differentiation, cell growth arrest and/or apoptosis of neoplastic cells, and/or inhibiting histone deacetylase (HDAC) by administration of pharmaceutical compositions comprising potent HDAC inhibitors. The oral bioavailability of the active compounds in the pharmaceutical compositions of the present invention is surprisingly high. Moreover, the pharmaceutical compositions unexpectedly give rise to high, therapeutically effective blood levels of the active compounds over an extended period of time. The present invention further provides a safe, daily dosing regimen of these pharmaceutical compositions, which is easy to follow, and which results in a therapeutically effective amount of the HDAC inhibitors in vivo. The present invention also provides a novel Form I polymorph of SAHA, characterized by a unique X-ray diffraction pattern and Differential Scanning Calorimetry profile, as well a unique crystalline structure.
    Patent expiration dates:
    • March 11, 2027
      ✓ 
      Drug substance
  • Polymorphs of suberoylanilide hydroxamic acid
    Patent 7,652,069
    Issued: January 26, 2010
    Inventor(s): Miller; Thomas A. & Richon; Victoria M.
    Assignee(s): Merck HDAC Research, LLC
    The present invention provides methods of selectively inducing terminal differentiation, cell growth arrest and/or apoptosis of neoplastic cells, and/or inhibiting histone deacetylase (HDAC) by administration of pharmaceutical compositions comprising potent HDAC inhibitors. The oral bioavailability of the active compounds in the pharmaceutical compositions of the present invention is surprisingly high. Moreover, the pharmaceutical compositions unexpectedly give rise to high, therapeutically effective blood levels of the active compounds over an extended period of time. The present invention further provides a safe, daily dosing regimen of these pharmaceutical compositions, which is easy to follow, and which results in a therapeutically effective amount of the HDAC inhibitors in vivo. The present invention also provides a novel Form I polymorph of SAHA, characterized by a unique X-ray diffraction pattern and Differential Scanning Calorimetry profile, as well a unique crystalline structure.
    Patent expiration dates:
    • March 4, 2023
      ✓ 
      Drug product
  • Methods of treating cancer
    Patent 7,732,490
    Issued: June 8, 2010
    Inventor(s): Richon; Victoria M. & Chiao; Judy H. & Kelly; William Kevin & Miller; Thomas A.
    Assignee(s): Merck HDAC Research, LLC Sloan-Kettering Institute for Cancer Research
    The present invention provides methods of selectively inducing terminal differentiation, cell growth arrest and/or apoptosis of neoplastic cells, and/or inhibiting histone deacetylase (HDAC) by administration of pharmaceutical compositions comprising potent HDAC inhibitors. The oral bioavailability of the active compounds in the pharmaceutical compositions of the present invention is surprisingly high. Moreover, the pharmaceutical compositions unexpectedly give rise to high, therapeutically effective blood levels of the active compounds over an extended period of time. The present invention further provides a safe, daily dosing regimen of these pharmaceutical compositions, which is easy to follow, and which results in a therapeutically effective amount of the HDAC inhibitors in vivo.
    Patent expiration dates:
    • March 4, 2023
      ✓ 
      Patent use: TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA (CTCL)
  • Polymorphs of suberoylanilide hydroxamic acid
    Patent 7,851,509
    Issued: December 14, 2010
    Inventor(s): Miller; Thomas A. & Richon; Victoria M.
    Assignee(s): Merck HDAC Research, LLC
    The present invention provides methods of selectively inducing terminal differentiation, cell growth arrest and/or apoptosis of neoplastic cells, and/or inhibiting histone deacetylase (HDAC) by administration of pharmaceutical compositions comprising potent HDAC inhibitors. The oral bioavailability of the active compounds in the pharmaceutical compositions of the present invention is surprisingly high. Moreover, the pharmaceutical compositions unexpectedly give rise to high, therapeutically effective blood levels of the active compounds over an extended period of time. The present invention further provides a safe, daily dosing regimen of these pharmaceutical compositions, which is easy to follow, and which results in a therapeutically effective amount of the HDAC inhibitors in vivo. The present invention also provides a novel Form I polymorph of SAHA, characterized by a unique X-ray diffraction pattern and Differential Scanning Calorimetry profile, as well a unique crystalline structure.
    Patent expiration dates:
    • February 21, 2024
      ✓ 
      Patent use: TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA (CTCL)
      ✓ 
      Drug product
  • Methods of treating Hodgkin's and non-Hodgkin's lymphoma
    Patent 8,067,472
    Issued: November 29, 2011
    Inventor(s): Richon; Victoria M. & Chiao; Judy H. & Kelly; William Kevin & Miller; Thomas A.
    Assignee(s): Merck HDAC Research, LLC Sloan-Kettering Institute for Cancer Research
    The present invention provides methods of selectively inducing terminal differentiation, cell growth arrest and/or apoptosis of neoplastic cells, and/or inhibiting histone deacetylase (HDAC) by administration of pharmaceutical compositions comprising potent HDAC inhibitors. The oral bioavailability of the active compounds in the pharmaceutical compositions of the present invention is surprisingly high. Moreover, the pharmaceutical compositions unexpectedly give rise to high, therapeutically effective blood levels of the active compounds over an extended period of time. The present invention further provides a safe, daily dosing regimen of these pharmaceutical compositions, which is easy to follow, and which results in a therapeutically effective amount of the HDAC inhibitors in vivo.
    Patent expiration dates:
    • March 4, 2023
      ✓ 
      Patent use: TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA (CTCL)
  • Formulations of suberoylanilide hydroxamic acid and methods for producing the same
    Patent 8,093,295
    Issued: January 10, 2012
    Inventor(s): Wong; Jeannie Chow & Cohen; Benjamin Max & Cote; Aaron S. & Dienemann; Erik A. & Gallagher; Kimberly & Ikeda; Craig & Moser; Justin & Rajniak; Pavol & Reed; Robert A. & Sell; Brian & Starbuck; Cindy & Tung; Hsien-Hsin & Wang; Qingxi & Capodanno; Vincent R.
    Assignee(s): Merck Sharp & Dohme Corp.
    The present invention provides a pharmaceutical composition or crystalline composition with a specific dissolution profile, which comprises suberoylanilide hydroxamic acid or a pharmaceutically acceptable salt or hydrate thereof as an active ingredient. The present invention provides a process of producing said crystalline composition or pharmaceutical composition. The present invention also provides compositions with a specific particle size distribution.
    Patent expiration dates:
    • May 16, 2026
      ✓ 
      Drug product
  • Polymorphs of suberoylanilide hydroxamic acid
    Patent 8,101,663
    Issued: January 24, 2012
    Inventor(s): Miller; Thomas A. & Richon; Victoria M.
    Assignee(s): Merck HDAC Research, LLC
    The present invention provides methods of selectively inducing terminal differentiation, cell growth arrest and/or apoptosis of neoplastic cells, and/or inhibiting histone deacetylase (HDAC) by administration of pharmaceutical compositions comprising potent HDAC inhibitors. The oral bioavailability of the active compounds in the pharmaceutical compositions of the present invention is surprisingly high. Moreover, the pharmaceutical compositions unexpectedly give rise to high, therapeutically effective blood levels of the active compounds over an extended period of time. The present invention further provides a safe, daily dosing regimen of these pharmaceutical compositions, which is easy to follow, and which results in a therapeutically effective amount of the HDAC inhibitors in vivo. The present invention also provides a novel Form I polymorph of SAHA, characterized by a unique X-ray diffraction pattern and Differential Scanning Calorimetry profile, as well a unique crystalline structure.
    Patent expiration dates:
    • March 4, 2023
      ✓ 
      Patent use: TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA (CTCL)
  • Potent inducers of terminal differentiation and methods of use thereof
    Patent RE38506
    Issued: April 20, 2004
    Inventor(s): Ronald; Breslow & Paul A.; Marks & Richard A.; Rifkind & Branko; Jursic
    Assignee(s): Sloan-Kettering Institute for Cancer Research The Trustees of Columbia University in the City of New York
    The present invention provides the compound having the structure: wherein each of R1 and R2 are independently the same as or different from each other; when R1 and R2 are the same, each is a substituted or unsubstituted arylamino, cycloalkylamino, pyridineamino, piperidino, 9-purine-6-amine, or thiozoleamino group; when R1 and R2 are different, R1=R3—N—R4, wherein each of R3 and R4 are independently the same as or different from each other and are a hydrogen atom, a hydroxyl group, a substituted or unsubstituted, branched or unbranched alkyl, alkenyl, cycloalkyl, aryl, alkyloxy, aryloxy, arylalkyloxy, or pyridine group, or R3 and R4 bond together to form a piperidine group and R2 is a hydroxylamino, hydroxyl, amino, alkylamino, dialkylamino or alkyloxy group; and n is an integer from about 4 to about 8. The present invention also provides a method of selectively inducing terminal differentiation of neoplastic cells and thereby inhibiting proliferation of such cells. Moreover, the present invention provides a method of treating a patient having a tumor characterized by proliferation of neoplastic cells. Lastly, the present invention provides a pharmaceutical composition and a therapeutically acceptable amount of the compound above.
    Patent expiration dates:
    • July 7, 2015
      ✓ 
      Drug substance
      ✓ 
      Drug product

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:
    • October 6, 2013 - 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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