`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
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`Home (index.cfm?resetfields=1) | 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 004
`LENALIDOMIDE (REVLIMID) CAPSULE 25MG
`
`Patent Data
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`Patent
`Use
`Code
`
`Delist
`Requested
`
`Submission
`Date
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=004&Appl_No=021880&Appl_type=N
`
`1/3
`
`ALVOGEN, Exh. 1060, p. 0001
`
`
`
`9/12/2018
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`004
`
`5635517 10/04/2019 DS
`
`6045501 08/28/2018
`
`6315720 10/23/2020
`
`6561976 08/28/2018
`
`6561977 10/23/2020
`
`6755784 10/23/2020
`
`6908432 08/28/2018
`
`7189740 04/11/2023
`
`7465800 04/27/2027 DS
`
`7468363 10/07/2023
`
`7855217 11/24/2024 DS
`
`DP
`
`DP
`
`7968569 10/07/2023
`
`8204763 08/28/2018
`
`8315886 10/23/2020
`
`8404717 04/11/2023
`
`8530498 05/15/2023
`
`8589188 08/28/2018
`
`8626531 10/23/2020
`
`8648095 05/15/2023
`
`8741929 03/08/2028
`
`9056120 04/11/2023
`
`9101621 05/15/2023
`
`Patent
`Use
`Code
`
`U-1210
`
`U-1210
`
`U-1210
`
`U-1210
`
`U-1210
`
`U-1210
`
`U-1215
`
`U-1414
`
`U-1216
`
`U-1249
`
`U-1249
`
`U-1215
`
`U-1216
`
`U-1210
`
`U-1210
`
`U-1216
`
`U-1414
`
`U-1215
`
`U-1216
`
`Delist
`Requested
`
`Submission
`Date
`
`07/14/2011
`
`09/26/2013
`
`02/05/2014
`
`06/17/2014
`
`07/09/2015
`
`08/26/2015
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=004&Appl_No=021880&Appl_type=N
`
`2/3
`
`ALVOGEN, Exh. 1060, p. 0002
`
`
`
`9/12/2018
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`004
`
`9101622 05/15/2023
`
`Patent
`Use
`Code
`
`U-1216
`
`Delist
`Requested
`
`Submission
`Date
`
`08/26/2015
`
`
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`004
`
`004
`
`004
`
`004
`
`I-706
`
`
`ODE-49
`
`
`
`ODE-88
`
`
`
`ODE-131
`
`
`
`02/17/2018
`
`06/05/2020
`
`02/17/2022
`
`02/22/2024
`
`
`View a list of all patent use codes (results_patent.cfm)
`View a list of all exclusivity codes (results_exclusivity.cfm)
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=004&Appl_No=021880&Appl_type=N
`
`3/3
`
`ALVOGEN, Exh. 1060, p. 0003
`
`