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  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
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Patent and Exclusivity for: N021880

Product 005
LENALIDOMIDE (REVLIMID) CAPSULE 2.5MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
005 5635517 10/04/2019 DS
01/17/2012
005 6315720 10/23/2020
U-1210 USE OF REVLIMID (LENALIDOMIDE) WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO REVLIMID (LENALIDOMIDE)
01/17/2012
005 6561977 10/23/2020
U-1210 USE OF REVLIMID (LENALIDOMIDE) WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO REVLIMID (LENALIDOMIDE)
01/17/2012
005 6755784 10/23/2020
U-1210 USE OF REVLIMID (LENALIDOMIDE) WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO REVLIMID (LENALIDOMIDE)
01/17/2012
005 7189740 04/11/2023
U-1982 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
01/17/2012
005 7465800 04/27/2027 DS DP
01/17/2012
005 7468363 10/07/2023
U-1983 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
U-2550 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT
U-2551 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT
06/27/2013
005 7855217 11/24/2024 DS DP
01/17/2012
005 7968569 10/07/2023
U-1984 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE
01/17/2012
005 8315886 10/23/2020
U-1249 TREATMENT OF MALE PATIENT HAVING A DISEASE OR CONDITION RESPONSIVE TO A TERATOGENIC DRUG
005 8404717 04/11/2023
U-1982 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
005 8492406 10/07/2023
U-2550 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT
06/25/2019
005 8530498 05/15/2023
U-1984 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE
09/26/2013
005 8626531 10/23/2020
U-1210 USE OF REVLIMID (LENALIDOMIDE) WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO REVLIMID (LENALIDOMIDE)
02/05/2014
005 8648095 05/15/2023
U-1984 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, IN COMBINATION WITH DEXAMETHASONE
005 8741929 03/08/2028
U-1983 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
06/17/2014
005 9056120 04/11/2023
U-1982 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
07/09/2015
005 9101621 05/15/2023
U-1985 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA, AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)
08/26/2015
005 9101622 05/15/2023
U-1986 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
08/26/2015
005 9155730 05/15/2023
U-2550 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT
06/25/2019
005 9393238 05/15/2023
U-2550 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PREVIOUSLY TREATED FOLLICULAR LYMPHOMA IN COMBINATION WITH A RITUXIMAB PRODUCT
06/25/2019

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
005
ODE-49 TREATMENT OF MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
COMPETITIVE GENERIC THERAPY
06/05/2020
005
ODE-88 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)
COMPETITIVE GENERIC THERAPY
02/17/2022
005
I-796 USED IN COMBINATION WITH A RITUXIMAB PRODUCT, ARE INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
COMPETITIVE GENERIC THERAPY
05/28/2022
005
I-797 USED IN COMBINATION WITH A RITUXIMAB PRODUCT, ARE INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
COMPETITIVE GENERIC THERAPY
05/28/2022
005
ODE-131 TREATMENT OF MULTIPLE MYELOMA (MM), AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)
COMPETITIVE GENERIC THERAPY
02/22/2024
005
ODE-241 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
COMPETITIVE GENERIC THERAPY
05/28/2026
005
ODE-245 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
COMPETITIVE GENERIC THERAPY
05/28/2026

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