Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

Additional Information about Patents

  • 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.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

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 6045501 08/28/2018
U-1210 USE OF REVLIMID (LENALIDOMIDE) WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO REVLIMID (LENALIDOMIDE)
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 6561976 08/28/2018
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 6908432 08/28/2018
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-1215 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF TRANSFUSION-DEPENDENT ANEMIA IN MYELODYSPLASTIC SYNDROMES (MDS)
01/17/2012
005 7465800 04/27/2027 DS DP
01/17/2012
005 7468363 10/07/2023
U-1414 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MANTLE CELL LYMPHOMA (MCL)
005 7855217 11/24/2024 DS DP
01/17/2012
005 7968569 10/07/2023
U-1216 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA
01/17/2012
005 8204763 08/28/2018
U-1249 TREATMENT OF MALE PATIENT HAVING A DISEASE OR CONDITION RESPONSIVE TO A TERATOGENIC DRUG
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-1215 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF TRANSFUSION-DEPENDENT ANEMIA IN MYELODYSPLASTIC SYNDROMES (MDS)
005 8530498 05/15/2023
U-1216 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA
09/26/2013
005 8589188 08/28/2018
U-1210 USE OF REVLIMID (LENALIDOMIDE) WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER CONTRAINDICATED INDIVIDUAL TO REVLIMID (LENALIDOMIDE)
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-1216 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA
005 8741929 03/08/2028
U-1414 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MANTLE CELL LYMPHOMA (MCL)
06/17/2014
005 9056120 04/11/2023
U-1215 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF TRANSFUSION-DEPENDENT ANEMIA IN MYELODYSPLASTIC SYNDROMES (MDS)
07/09/2015
005 9101621 05/15/2023
U-1216 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA
08/26/2015
005 9101622 05/15/2023
U-1216 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA
08/26/2015

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
005
I-706 EXPANDED INDICATION FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
COMPETITIVE GENERIC THERAPY
02/17/2018
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
ODE-131 TREATMENT OF MULTIPLE MYELOMA (MM), AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)
COMPETITIVE GENERIC THERAPY
02/22/2024

View a list of all patent use codes
View a list of all exclusivity codes

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English