Generic Revlimid Availability
Revlimid is a brand name of lenalidomide, approved by the FDA in the following formulation(s):
REVLIMID (lenalidomide - capsule; oral)
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Manufacturer: CELGENE
Approval date: December 27, 2005
Strength(s): 10MG, 5MG -
Manufacturer: CELGENE
Approval date: June 29, 2006
Strength(s): 15MG, 25MG [RLD] -
Manufacturer: CELGENE
Approval date: December 21, 2011
Strength(s): 2.5MG
Has a generic version of Revlimid been approved?
No. There is currently no therapeutically equivalent version of Revlimid available.
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: 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.
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Method of reducing TNF.alpha. levels with amino substituted 2-(2,6-dioxopiperidin-3-yl)-1-oxo-and 1,3-dioxoisoindolines
Patent 5,635,517
Issued: June 3, 1997
Inventor(s): Muller; George W. & Stirling; David I. & Chen; Roger S. -C.
Assignee(s): Celgene Corporation
1-Oxo- and 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl) isoindolines substituted with amino in the benzo ring reduce the levels of TNF.alpha. in a mammal. A typical embodiment is 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-5-aminoisoindoline.Patent expiration dates:- October 4, 2019✓✓
- October 4, 2019
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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✓
- August 28, 2018
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Isoindolines, method of use, and pharmaceutical compositions
Patent 6,281,230
Issued: August 28, 2001
Inventor(s): Muller; George W. & Stirling; David I. & Chen; Roger Shen-Chu
Assignee(s): Celgene Corporation
Substituted 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines are useful in treating inflammation, inflammatory disease, autoimmune disease, and oncogenic or cancerous conditions in a mammal. Typical embodiments are 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline and 1-oxo-2-(2,6-dioxo-3-methylpiperidin-3-yl)-4-aminoisoindoline.Patent expiration dates:- July 24, 2016✓
- July 24, 2016
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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✓
- October 23, 2020
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Isoindolines, method of use, and pharmaceutical compositions
Patent 6,555,554
Issued: April 29, 2003
Inventor(s): George W.; Muller & David I.; Stirling & Roger Shen-Chu; Chen
Assignee(s): Celgene Corporation
Substituted 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines are useful in reducing undesirable levels of TNF&agr; in a mammal. Typical embodiments are pharmaceutical compositions containing 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline and 1-oxo-2-(2,6-dioxo-3-methylpiperidin-3-yl)-4-aminoisoindoline.Patent expiration dates:- July 24, 2016✓✓
- July 24, 2016
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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✓
- August 28, 2018
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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✓
- October 23, 2020
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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✓
- October 23, 2020
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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✓
- August 28, 2018
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Pharmaceutical compositions of 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline
Patent 7,119,106
Issued: October 10, 2006
Inventor(s): Muller; George W. & Stirling; David I. & Chen; Roger Shen-Chu
Assignee(s): Celgene Corporation
Substituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines reduce the levels of TNFα in a mammal. Typical embodiments are 1-oxo-2-(2,6-dioxo-3-methylpiperidin-3-yl)-4,5,6,7-tetrafuoroisoindoline and 1,3-dioxo-2-(2,6-dioxo-3 -methylpiperidin-3-yl)-4-aminoisoindoline.Patent expiration dates:- July 24, 2016✓
- July 24, 2016
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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✓
- April 11, 2023
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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✓✓
- April 27, 2027
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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✓✓
- November 24, 2024
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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✓
- October 7, 2023
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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✓
- August 28, 2018
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Pharmaceutical compositions of 3-(4-amino-1-oxoisoindolin-2yl)-piperidine-2,6-dione
Patent 8,288,415
Issued: October 16, 2012
Inventor(s): Muller; George W. & Stirling; David I. & Chen; Roger Shen-Chu
Assignee(s): Celgene Corporation
Substituted 2-(2,6-dioxopiperidin-3-yl)phthalimides and 1-oxo-2-(2,6-dioxopiperidin-3-yl)isoindolines are disclosed. The compounds are useful, for example, in reducing the levels of TNFα in a mammal.Patent expiration dates:- July 24, 2016✓✓
- July 24, 2016
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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✓
- October 23, 2020
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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✓
- April 11, 2023
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:
- December 27, 2012 - ORPHAN DRUG EXCLUSIVITY
- June 29, 2013 - ORPHAN DRUG EXCLUSIVITY
See also...
- Revlimid Consumer Information (Drugs.com)
- Revlimid Consumer Information (Wolters Kluwer)
- Revlimid Consumer Information (Cerner Multum)
- Revlimid Advanced Consumer Information (Micromedex)
- Revlimid AHFS DI Monographs (ASHP)
- Lenalidomide Consumer Information (Wolters Kluwer)
- Lenalidomide Consumer Information (Cerner Multum)
- Lenalidomide Advanced Consumer Information (Micromedex)
- Lenalidomide AHFS DI Monographs (ASHP)
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. |


