`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/)
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence
`Evaluations
`
`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: N022561
`
`Product 001
`CLADRIBINE (MAVENCLAD) TABLET 10MG
`
`Patent Data
`
`Product
`No
`001
`
`001
`
`001
`
`001
`
`001
`
`Patent
`No
`7713947
`
`Patent
`Expiration
`10/16/2026
`
`7888328
`
`04/11/2024
`
`8377903
`
`05/31/2026
`
`8785415
`
`04/11/2024
`
`10849919 11/23/2038
`
`Exclusivity Data
`
`Drug
`Substance
`
`Drug
`Product
`
`DP
`
`DP
`
`Patent
`Use
`Code
`U-2520
`U-2521
`U-2522
`U-2523
`U-3411
`
`Delist
`Requested
`
`Submission
`Date
`05/28/2019
`
`05/28/2019
`
`05/28/2019
`
`05/28/2019
`
`09/09/2022
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022561&Appl_type=N
`
`1/2
`
`Petitioner TWi Pharms., Inc.
`EX1033, Page 1 of 2
`
`
`
`10/5/22, 9:49 AM
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product No
`001
`
`Exclusivity Code
`NP
`
`Exclusivity Expiration
`03/29/2022
`
`
`
`
`
`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=001&Appl_No=022561&Appl_type=N
`
`2/2
`
`Petitioner TWi Pharms., Inc.
`EX1033, Page 2 of 2
`
`
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