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Generic Pomalyst Availability

Last updated on Mar 9, 2023.

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

POMALYST (pomalidomide - capsule;oral)

  • Manufacturer: BRISTOL
    Approval date: February 8, 2013
    Strength(s): 1MG [RLD], 2MG [RLD], 3MG [RLD], 4MG [RLD]

Has a generic version of Pomalyst been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Pomalyst. 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: Generic Drug FAQ.

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.

  • Patent 10,555,939

    Patent expiration dates:

    • May 19, 2030
      ✓ 
      Drug product
  • Patent 10555939*

    Patent expiration dates:

    • November 19, 2030
  • Methods for treating multiple myeloma using 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
    Patent 8,198,262
    Issued: June 12, 2012
    Inventor(s): Zeldis; Jerome B.
    Assignee(s): Celgene Corporation

    Methods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.

    Patent expiration dates:

    • June 17, 2025
      ✓ 
      Patent use: USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
    • June 17, 2025
      ✓ 
      Patent use: USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
    • December 17, 2025
      ✓ 
      Pediatric exclusivity
  • Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
    Patent 8,673,939
    Issued: March 18, 2014
    Assignee(s): Celgene Corporation

    Methods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.

    Patent expiration dates:

    • May 15, 2023
      ✓ 
      Patent use: USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
    • May 15, 2023
      ✓ 
      Patent use: USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
    • November 15, 2023
      ✓ 
      Pediatric exclusivity
  • Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione
    Patent 8,735,428
    Issued: May 27, 2014
    Assignee(s): Celgene Corporation

    Methods of treating, preventing and/or managing cancer as well as and diseases and disorders associated with, or characterized by, undesired angiogenesis are disclosed. Specific methods encompass the administration of an immunomodulatory compound alone or in combination with a second active ingredient. The invention further relates to methods of reducing or avoiding adverse side effects associated with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy which comprise the administration of an immunomodulatory compound. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.

    Patent expiration dates:

    • May 15, 2023
      ✓ 
      Patent use: USE OF POMALIDOMIDE WITH DEXAMETHASONE FOR PATIENTS WITH MULTIPLE MYELOMA AFTER AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR AND DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETING THE LAST THERAPY
    • May 15, 2023
      ✓ 
      Patent use: USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
    • November 15, 2023
      ✓ 
      Pediatric exclusivity
  • Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
    Patent 8,828,427
    Issued: September 9, 2014
    Assignee(s): Celgene Corporation

    Pharmaceutical compositions and single unit dosage forms of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate, are provided herein. Also provided are methods of treating, managing, or preventing various disorders, such as cancer or an inflammatory disease.

    Patent expiration dates:

    • June 21, 2031
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • December 21, 2031
      ✓ 
      Pediatric exclusivity
  • Formulations of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione
    Patent 9,993,467
    Issued: June 12, 2018
    Assignee(s): Celgene Corporation

    Pharmaceutical compositions and single unit dosage forms of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate, are provided herein. Also provided are methods of treating, managing, or preventing various disorders, such as cancer or an inflammatory disease.

    Patent expiration dates:

    • May 19, 2030
      ✓ 
      Drug product
    • November 19, 2030
      ✓ 
      Pediatric exclusivity

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, 2023 - ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
    • May 20, 2024 - PEDIATRIC EXCLUSIVITY
    • May 14, 2027 - INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART)
    • May 14, 2027 - FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE
    • November 14, 2027 - PEDIATRIC EXCLUSIVITY

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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