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Generic Zydelig Availability

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

ZYDELIG (idelalisib - tablet;oral)

  • Manufacturer: GILEAD SCIENCES INC
    Approval date: July 23, 2014
    Strength(s): 100MG, 150MG [RLD]

Has a generic version of Zydelig been approved?

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

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

  • Inhibitors of human phosphatidylinositol 3-kinase delta
    Patent 6,800,620
    Issued: October 5, 2004
    Inventor(s): Chanchal; Sadhu & Ken; Dick & Jennifer; Treiberg & C. Gregory; Sowell & Edward A.; Kesicki & Amy; Oliver
    Assignee(s): ICOS
    Methods of inhibiting phosphatidylinositol 3-kinase delta isoform (PI3K&dgr;) activity, and methods of treating diseases, such as disorders of immunity and inflammation, in which PI3K&dgr; plays a role in leukocyte function are disclosed. Preferably, the methods employ active agents that selectively inhibit PI3K&dgr;, while not significantly inhibiting activity of other PI3K isoforms. Compounds are provided that inhibit PI3K&dgr; activity, including compounds that selectively inhibit PI3K&dgr; activity. Methods of using PI3K&dgr; inhibitory compounds to inhibit cancer cell growth or proliferation are also provided. Accordingly, the invention provides methods of using PI3K&dgr; inhibitory compounds to inhibit PI3K&dgr;-mediated processes in vitro and in vivo.
    Patent expiration dates:
    • April 24, 2021
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      Patent use: A METHOD OF DISRUPTING LEUKOCYTE FUNCTION, INCLUDING AS AN INHIBITOR OF PI3KDELTA KINASE
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      Drug substance
  • Inhibitors of human phosphatidyl-inositol 3-kinase delta
    Patent 6,949,535
    Issued: September 27, 2005
    Inventor(s): Sadhu; Chanchal & Dick; Ken & Treiberg; Jennifer & Sowell; C. Gregory & Kesicki; Edward A. & Oliver; Amy
    Assignee(s): ICOS Corporation
    Methods of inhibiting phosphatidylinositol 3-kinase delta isoform (PI3Kδ) activity, and methods of treating diseases, such as disorders of immunity and inflammation, in which PI3Kδ plays a role in leukocyte function are disclosed. Preferably, the methods employ active agents that selectively inhibit PI3Kδ, while not significantly inhibiting activity of other PI3K isoforms. Compounds are provided that inhibit PI3Kδ activity, including compounds that selectively inhibit PI3Kδ activity. Methods of using PI3Kδ inhibitory compounds to inhibit cancer cell growth or proliferation are also provided. Accordingly, the invention provides methods of using PI3Kδ inhibitory compounds to inhibit PI3Kδ-mediated processes in vitro and in vivo.
    Patent expiration dates:
    • April 24, 2021
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      Patent use: A METHOD OF DISRUPTING LEUKOCYTE FUNCTION, INCLUDING AS AN INHIBITOR OF PI3KDELTA KINASE
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      Drug substance
  • Inhibitors of human phosphatidylinositol 3-kinase delta
    Patent 8,138,195
    Issued: March 20, 2012
    Inventor(s): Sadhu; Chanchal & Dick; Kenneth O. & Treiberg; Jennifer & Sowell; C. Gregory & Kesicki; Edward A. & Oliver; Amy
    Assignee(s): ICOS Corporation
    Methods of inhibiting phosphatidylinositol 3-kinase delta isoform (PI3Kδ) activity, and methods of treating diseases, such as disorders of immunity and inflammation, in which PI3Kδ plays a role in leukocyte function are disclosed. Preferably, the methods employ active agents that selectively inhibit PI3Kδ, while not significantly inhibiting activity of other PI3K isoforms. Compounds are provided that inhibit PI3Kδ activity, including compounds that selectively inhibit PI3Kδ activity. Methods of using PI3Kδ inhibitory compounds to inhibit cancer cell growth or proliferation are also provided. Accordingly, the invention provides methods of using PI3Kδ inhibitory compounds to inhibit PI3Kδ-mediated processes in vitro and in vivo.
    Patent expiration dates:
    • April 24, 2021
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      Patent use: FOR THE TREATMENT OF PATIENTS WITH RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA
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      Drug substance
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      Drug product
  • Inhibitors of human phosphatidylinositol 3-kinase delta
    Patent 8,492,389
    Issued: July 23, 2013
    Assignee(s): ICOS Corporation
    Methods of inhibiting phosphatidylinositol 3-kinase delta isoform (PI3Kδ) activity, and methods of treating diseases, such as disorders of immunity and inflammation, in which PI3Kδ plays a role in leukocyte function are disclosed. Preferably, the methods employ active agents that selectively inhibit PI3Kδ, while not significantly inhibiting activity of other PI3K isoforms. Compounds are provided that inhibit PI3Kδ activity, including compounds that selectively inhibit PI3Kδ activity. Methods of using PI3Kδ inhibitory compounds to inhibit cancer cell growth or proliferation are also provided. Accordingly, the invention provides methods of using PI3Kδ inhibitory compounds to inhibit PI3Kδ-mediated processes in vitro and in vivo.
    Patent expiration dates:
    • April 24, 2021
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  • Inhibitors of human phosphatidylinositol 3-kinase delta
    Patent 8,637,533
    Issued: January 28, 2014
    Assignee(s): ICOS Corporation
    Methods of inhibiting phosphatidylinositol 3-kinase delta isoform (PI3Kδ) activity, and methods of treating diseases, such as disorders of immunity and inflammation, in which PI3Kδ plays a role in leukocyte function are disclosed. Preferably, the methods employ active agents that selectively inhibit PI3Kδ, while not significantly inhibiting activity of other PI3K isoforms. Compounds are provided that inhibit PI3Kδ activity, including compounds that selectively inhibit PI3Kδ activity. Methods of using PI3Kδ inhibitory compounds to inhibit cancer cell growth or proliferation are also provided. Accordingly, the invention provides methods of using PI3Kδ inhibitory compounds to inhibit PI3Kδ-mediated processes in vitro and in vivo.
    Patent expiration dates:
    • April 24, 2021
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      Drug substance
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      Drug product
  • Polymorphic forms of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one
    Patent 8,865,730
    Issued: October 21, 2014
    Assignee(s): Gilead Calistoga LLC
    Polymorphs of (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one, compositions thereof, methods for their preparation, and methods for their use are disclosed.
    Patent expiration dates:
    • March 5, 2033
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      Patent use: FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
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  • 5-fluoro-3-phenyl-2[1-(9H-purin-6-ylamino)propyl]-3H-quinazolin-4-one and 6-fluoro-3-phenyl-2-[1-(9H-purin-6-ylamino)ethyl]-3H-quinazolin-4-one as inhibitors of human phosphatidylinositol 3-kinase delta
    Patent 8,980,901
    Issued: March 17, 2015
    Assignee(s): Icos Corporation
    Compounds that inhibit PI3Kδ activity, including compounds that selectively inhibit PI3Kδ activity, are disclosed. Methods of inhibiting phosphatidylinositol 3-kinase delta isoform (PI3Kδ) activity, and methods of treating diseases, such as disorders of immunity and inflammation in which PI3Kδ plays a role in leukocyte function, using the compounds also are disclosed. Exemplary compounds disclosed in this application are shown below:
    Patent expiration dates:
    • May 12, 2025
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      Patent use: FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
  • 5-fluoro-3-phenyl-2-[1-(9h-purin-6-ylamino)propyl]-3h-quinazolin-4-one as an inhibitor of human phosphatidylinositol 3-kinase delta
    Patent 9,149,477
    Issued: October 6, 2015
    Assignee(s): ICOS Corporation
    Compounds that inhibit PI3Kδ activity, including compounds that selectively inhibit PI3Kδ activity, are disclosed. Methods of inhibiting phosphatidylinositol 3-kinase delta isoform (PI3Kδ) activity, and methods of treating diseases, such as disorders of immunity and inflammation in which PI3Kδ plays a role in leukocyte function, using the compounds also are disclosed. An exemplary compound disclosed in this application is shown below:
    Patent expiration dates:
    • May 12, 2025
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      Patent use: INHIBITION ON PI3K KINASE
  • Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
    Patent RE44599
    Issued: November 12, 2013
    Assignee(s): ICOS Corporation
    Compounds that inhibit P13Kδ activity, including compounds that selectively inhibit P13Kδ activity, are disclosed. Methods of inhibiting phosphatidylinositol 3-kinase delta isoform (P13Kδ) activity, and methods of treating diseases, such as disorders of immunity and inflammation in which P13Kδ plays a role in leukocyte function, using the compounds also are disclosed.
    Patent expiration dates:
    • July 21, 2025
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      Patent use: FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL
    • July 21, 2025
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      Patent use: FOR THE TREATMENT OF PATIENTS WITH RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA OR [RELAPSED] SMALL LYMPHOCYTIC LYMPHOMA
  • Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
    Patent RE44638
    Issued: December 10, 2013
    Assignee(s): ICOS Corporation
    The invention provides a class of substituted quinazolinone compounds and methods of treating diseases mediated by PI3Kδ activity. The disclosed compounds are useful in treating diseases such as bone-resorption disorders; and cancer, especially hematopoietic cancers, lymphomas, multiple myelomas and leukemia. The compounds are also useful in disrupting or inhibiting cellular processes such as leukocyte function or accumulation, neutrophils function, lymphocyte proliferation, and endogenous immune responses.
    Patent expiration dates:
    • August 5, 2025
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      Drug substance
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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:
    • July 23, 2019 - NEW CHEMICAL ENTITY

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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