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Generic Revlimid Availability

Last updated on July 7, 2021.

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

REVLIMID (lenalidomide - capsule;oral)

  • Manufacturer: CELGENE
    Approval date: December 27, 2005
    Strength(s): 5MG [RLD] [AB], 10MG [RLD] [AB]
  • Manufacturer: CELGENE
    Approval date: June 29, 2006
    Strength(s): 15MG [RLD] [AB], 25MG [RLD] [AB]
  • Manufacturer: CELGENE
    Approval date: December 21, 2011
    Strength(s): 2.5MG [RLD]
  • Manufacturer: CELGENE
    Approval date: June 5, 2013
    Strength(s): 20MG [RLD]

Has a generic version of Revlimid been approved?

A generic version of Revlimid has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Revlimid and have been approved by the FDA:

lenalidomide capsule;oral

  • Manufacturer: NATCO PHARMA LTD
    Approval date: May 21, 2021
    Strength(s): 5MG [AB], 10MG [AB], 15MG [AB], 25MG [AB]

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

  • Methods of using 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for the treatment and management of myelodysplastic syndromes
    Patent 7,189,740
    Issued: March 13, 2007
    Inventor(s): Zeldis; Jerome B.
    Assignee(s): Celgene Corporation

    Methods of treating, preventing and/or managing myclodysplastic syndromes are disclosed. Specific methods encompass the administration of an immunomodulatory compound, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof, alone or in combination with a second active ingredient, and/or the transplantation of blood or cells. Specific second active ingredients are capable of affecting or blood cell production. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.

    Patent expiration dates:

    • April 11, 2023
      ✓ 
      Patent use: USE OF REVLIMID (LENALIDOMIDE) FOR TREATMENT OF PATIENTS WITH TRANSFUSION-DEPENDENT ANEMIA DUE TO LOW-OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES ASSOCIATED WITH A DELETION 5Q ABNORMALITY WITH OR WITHOUT ADDITIONAL CYTOGENETIC ABNORMALITIES
  • Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
    Patent 7,465,800
    Issued: December 16, 2008
    Inventor(s): Jaworsky; Markian S. & Chen; Roger Shen-Chu & Muller; George W.
    Assignee(s): Celgene Corporation

    Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione are disclosed. Compositions comprising the polymorphic forms, methods of making the polymorphic forms and methods of their use are also disclosed.

    Patent expiration dates:

    • April 27, 2027
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      Drug substance
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      Drug product
  • Methods for treatment of cancers using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione
    Patent 7,468,363
    Issued: December 23, 2008
    Inventor(s): Zeldis; Jerome B.
    Assignee(s): Celgene Corporation

    Methods of treating a specific cancer or amyloidosis are disclosed. Specific methods encompass the administration of 3-(4-amino-1 oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione alone or in combination with a second active ingredient.

    Patent expiration dates:

    • October 7, 2023
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      Patent use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT
    • October 7, 2023
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      Patent use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
    • October 7, 2023
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      Patent use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT
  • Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
    Patent 7,855,217
    Issued: December 21, 2010
    Inventor(s): Jaworsky; Markian S. & Chen; Roger Shen-Chu & Muller; George W.
    Assignee(s): Celgene Corporation

    Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione are disclosed. Compositions comprising the polymorphic forms, methods of making the polymorphic forms and methods of their use are also disclosed.

    Patent expiration dates:

    • November 24, 2024
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      Drug substance
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      Drug product
  • Methods for treatment of multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione
    Patent 7,968,569
    Issued: June 28, 2011
    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:

    • October 7, 2023
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      Patent use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE
  • Methods of treating myelodysplastic syndromes using lenalidomide
    Patent 8,404,717
    Issued: March 26, 2013
    Assignee(s): Celgene Corporation

    Methods of treating, preventing and/or managing myelodysplastic syndromes are disclosed. Specific methods encompass the administrations of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidin-2,6-dione in combination with 5-azacytidine.

    Patent expiration dates:

    • April 11, 2023
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      Patent use: USE OF REVLIMID (LENALIDOMIDE) FOR TREATMENT OF PATIENTS WITH TRANSFUSION-DEPENDENT ANEMIA DUE TO LOW-OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES ASSOCIATED WITH A DELETION 5Q ABNORMALITY WITH OR WITHOUT ADDITIONAL CYTOGENETIC ABNORMALITIES
  • Methods for treatment of follicular lymphoma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione
    Patent 8,492,406
    Issued: July 23, 2013
    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:

    • October 7, 2023
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      Patent use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT
  • Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)piperidine-2,6-dione
    Patent 8,530,498
    Issued: September 10, 2013
    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
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      Patent use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE
  • Methods for treating multiple myeloma using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with proteasome inhibitor
    Patent 8,648,095
    Issued: February 11, 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 REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE
  • Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of mantle cell lymphomas
    Patent 8,741,929
    Issued: June 3, 2014
    Assignee(s): Celgene Corporation

    Methods of treating, preventing or managing mantle cell lymphomas are disclosed. The methods encompass the administration of an immunomodulatory compound of the invention known as Revlimid® or lenalidomide. The invention further relates to methods of treatment using this compound with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy. Pharmaceutical compositions and single unit dosage forms suitable for use in the methods of the invention are also disclosed.

    Patent expiration dates:

    • March 8, 2028
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      Patent use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
  • Methods of treating myelodysplastic syndromes with a combination therapy using lenalidomide and azacitidine
    Patent 9,056,120
    Issued: June 16, 2015
    Assignee(s): Celgene Corporation

    Methods of treating, preventing and/or managing myelodysplastic syndromes are disclosed. Specific methods encompass the administrations of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidin-2,6-dione in combination with 5-azacytidine.

    Patent expiration dates:

    • April 11, 2023
      ✓ 
      Patent use: USE OF REVLIMID (LENALIDOMIDE) FOR TREATMENT OF PATIENTS WITH TRANSFUSION-DEPENDENT ANEMIA DUE TO LOW-OR INTERMEDIATE-1-RISK MYELODYSPLASTIC SYNDROMES ASSOCIATED WITH A DELETION 5Q ABNORMALITY WITH OR WITHOUT ADDITIONAL CYTOGENETIC ABNORMALITIES
  • Methods for treating multiple myeloma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione after stem cell transplantation
    Patent 9,101,621
    Issued: August 11, 2015
    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
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      Patent use: USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)
  • Methods for treating newly diagnosed multiple myeloma 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with dexamethasone
    Patent 9,101,622
    Issued: August 11, 2015
    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 REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE, WHEREIN THOSE PATIENTS HAVE NOT RECEIVED PREVIOUS TREATMENT FOR MULTIPLE MYELOMA
  • Methods for treating non-hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent
    Patent 9,155,730
    Issued: October 13, 2015
    Assignee(s): Calgene 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 REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT
  • Methods for treating non-hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent
    Patent 9,393,238
    Issued: July 19, 2016
    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 REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB 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 17, 2022 - FOR USE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE TREATMENT)
    • May 28, 2022 - USED IN COMBINATION WITH A RITUXIMAB PRODUCT, ARE INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
    • May 28, 2022 - USED IN COMBINATION WITH A RITUXIMAB PRODUCT, ARE INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
    • February 22, 2024 -
    • May 28, 2026 -
    • May 28, 2026 -

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

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