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Generic Ninlaro Availability

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

NINLARO (ixazomib citrate - capsule;oral)

  • Manufacturer: MILLENNIUM PHARMS
    Approval date: November 20, 2015
    Strength(s): EQ 2.3MG BASE, EQ 3MG BASE, EQ 4MG BASE [RLD]

Has a generic version of Ninlaro been approved?

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

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

  • Proteasome inhibitors
    Patent 7,442,830
    Issued: October 28, 2008
    Inventor(s): Olhava; Edward J. & Danca; Mihaela Diana
    Assignee(s): Millenium Pharmaceuticals, Inc.
    The present invention provides novel compounds useful as proteasome inhibitors. The invention also provides pharmaceutical compositions comprising the compounds of the invention and methods of using the compositions in the treatment of various diseases.
    Patent expiration dates:
    • August 6, 2027
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      Patent use: METHOD FOR TREATING CANCER, INCLUDING MULTIPLE MYELOMA
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      Drug product
  • Proteasome inhibitors
    Patent 7,687,662
    Issued: March 30, 2010
    Inventor(s): Olhava; Edward J. & Danca; Mihaela Diana
    Assignee(s): Millennium Pharmaceuticals, Inc.
    The present invention provides novel compounds useful as proteasome inhibitors. The invention also provides pharmaceutical compositions comprising the compounds of the invention and methods of using the compositions in the treatment of various diseases.
    Patent expiration dates:
    • August 6, 2027
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      Drug substance
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  • Proteasome inhibitors
    Patent 8,003,819
    Issued: August 23, 2011
    Inventor(s): Olhava; Edward J. & Danca; Mihaela Diana
    Assignee(s): Millennium Pharmaceuticals, Inc.
    The present invention provides novel compounds useful as proteasome inhibitors. The invention also provides pharmaceutical compositions comprising the compounds of the invention and methods of using the compositions in the treatment of various diseases.
    Patent expiration dates:
    • August 6, 2027
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      Patent use: METHOD FOR TREATING CANCER, INCLUDING MULTIPLE MYELOMA
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      Drug substance
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      Drug product
  • Proteasome inhibitors
    Patent 8,530,694
    Issued: September 10, 2013
    Assignee(s): Millennium Pharmaceuticals, Inc.
    The present invention provides novel compounds useful as proteasome inhibitors. The invention also provides pharmaceutical compositions comprising the compounds of the invention and methods of using the compositions in the treatment of various diseases.
    Patent expiration dates:
    • August 6, 2027
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      Patent use: METHOD FOR TREATING CANCER, INCLUDING MULTIPLE MYELOMA
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      Drug product
  • Proteasome inhibitors and methods of using the same
    Patent 8,546,608
    Issued: October 1, 2013
    Assignee(s): Cephalon, Inc.
    The present invention provides boronic acid compounds, boronic esters, and compositions thereof that can modulate apoptosis such as by inhibition of proteasome activity. The compounds and compositions can be used in methods of inducing apoptosis and treating diseases such as cancer and other disorders associated directly of indirectly with proteasome activity.
    Patent expiration dates:
    • August 12, 2024
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  • Boronate ester compounds and pharmaceutical compositions thereof
    Patent 8,859,504
    Issued: October 14, 2014
    Assignee(s): Millennium Pharmaceuticals, Inc.
    The present invention provides novel compounds useful as proteasome inhibitors. The invention also provides pharmaceutical compositions comprising the compounds of the invention and methods of using the compositions in the treatment of various diseases.
    Patent expiration dates:
    • June 16, 2029
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  • Proteasome inhibitors
    Patent 8,871,745
    Issued: October 28, 2014
    Assignee(s): Millennium Pharmaceuticals, Inc.
    The present invention provides novel compounds useful as proteasome inhibitors. The invention also provides pharmaceutical compositions comprising the compounds of the invention and methods of using the compositions in the treatment of various diseases.
    Patent expiration dates:
    • August 6, 2027
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      Patent use: METHOD FOR TREATING MULTIPLE MYELOMA WITH ONE OR MORE OTHER THERAPEUTIC AGENTS
  • Boronate ester compounds and pharmaceutical compositions thereof
    Patent 9,175,017
    Issued: November 3, 2015
    The present invention provides novel compounds useful as proteasome inhibitors. The invention also provides pharmaceutical compositions comprising the compounds of the invention and methods of using the compositions in the treatment of various diseases.
    Patent expiration dates:
    • June 16, 2029
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      Patent use: METHOD FOR TREATING MULTIPLE MYELOMA
  • Proteasome inhibitors and methods of using the same
    Patent 9,233,115
    Issued: January 12, 2016
    Assignee(s): Millennium Pharmaceuticals Inc.
    The present invention provides boronic acid compounds, boronic esters, and compositions thereof that can modulate apoptosis such as by inhibition of proteasome activity. The compounds and compositions can be used in methods of inducing apoptosis and treating diseases such as cancer and other disorders associated directly of indirectly with proteasome activity.
    Patent expiration dates:
    • August 12, 2024
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      Patent use: METHOD FOR TREATING MULTIPLE MYELOMA

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:
    • November 20, 2020 - NEW CHEMICAL ENTITY
    • November 20, 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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