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Generic Pomalyst Availability

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

POMALYST (pomalidomide - capsule;oral)

  • Manufacturer: CELGENE
    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 FAQs.

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 for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
    Patent 6,045,501
    Issued: April 4, 2000
    Inventor(s): Elsayed; Marc & Williams; Bruce
    Assignee(s): Celgene Corporation

    Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.

    Patent expiration dates:

    • August 28, 2018
      ✓ 
      Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
  • Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
    Patent 6,315,720
    Issued: November 13, 2001
    Inventor(s): Williams; Bruce A. & Kaminski; Joseph K.
    Assignee(s): Celgene Corporation

    Improved methods for delivering to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug are disclosed. The methods are of the type in which prescriptions for the drug are filled only after a computer readable storage medium has been consulted to assure that the prescriber, pharmacy and patient have been properly registered in the medium before the patient is approved to receive the drug. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to the side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.

    Patent expiration dates:

    • October 23, 2020
      ✓ 
      Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
  • Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
    Patent 6,561,976
    Issued: May 13, 2003
    Inventor(s): Marc; Elsayed & Bruce; Williams
    Assignee(s): Celgene Corporation

    Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.

    Patent expiration dates:

    • August 28, 2018
      ✓ 
      Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
  • Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
    Patent 6,561,977
    Issued: May 13, 2003
    Inventor(s): Bruce A.; Williams & Joseph K.; Kaminski
    Assignee(s): Celgene Corporation

    Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.

    Patent expiration dates:

    • October 23, 2020
      ✓ 
      Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
  • Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
    Patent 6,755,784
    Issued: June 29, 2004
    Inventor(s): Bruce A.; Williams & Joseph K.; Kaminski
    Assignee(s): Celgene Corporation

    Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.

    Patent expiration dates:

    • October 23, 2020
      ✓ 
      Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
  • Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
    Patent 6,908,432
    Issued: June 21, 2005
    Inventor(s): Elsayed; Marc & Williams; Bruce
    Assignee(s): Celgene Corporation

    Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.

    Patent expiration dates:

    • August 28, 2018
      ✓ 
      Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
  • 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
  • Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
    Patent 8,204,763
    Issued: June 19, 2012
    Inventor(s): Elsayed; Marc & Williams; Bruce
    Assignee(s): Celgene Corporation

    Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.

    Patent expiration dates:

    • August 28, 2018
      ✓ 
      Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
  • Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
    Patent 8,315,886
    Issued: November 20, 2012
    Inventor(s): Williams; Bruce A. & Kaminski; Joseph K.
    Assignee(s): Celgene Corporation

    Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.

    Patent expiration dates:

    • October 23, 2020
      ✓ 
      Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
  • Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
    Patent 8,589,188
    Issued: November 19, 2013
    Assignee(s): Celgene Corporation

    Novel methods for delivering a drug to a patient while preventing the exposure of a fetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to fetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.

    Patent expiration dates:

    • August 28, 2018
      ✓ 
      Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
  • Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
    Patent 8,626,531
    Issued: January 7, 2014
    Assignee(s): Celgene Corporation

    Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.

    Patent expiration dates:

    • October 23, 2020
      ✓ 
      Patent use: USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
  • 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
  • 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
  • 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
  • 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

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 8, 2018 - NEW CHEMICAL ENTITY
    • April 23, 2018 - POMALYST, IN COMBINATION WITH DEXAMETHASONE, IS INDICATED FOR PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 2 PRIOR THERAPIES AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
    • February 8, 2020 - TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND BORTEZOMIB AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY.

Further information

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

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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