`
`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: N210563
`
`Product 003
`IBRUTINIB (IMBRUVICA) TABLET 420MG
`
`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=003&Appl_No=210563&Appl_type=N
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`003
`
`10004746 06/03/2031
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`10010507 03/03/2036
`
`10016435 06/03/2031
`
`10106548 06/03/2033 DS
`
`10125140 06/03/2033 DS
`
`7514444
`
`12/28/2026 DS
`
`8008309
`
`12/28/2026 DS
`
`8476284
`
`12/28/2026
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`003
`
`8497277
`
`12/28/2026
`
`003
`
`8563563
`
`04/26/2027
`
`003
`
`003
`
`8697711
`
`12/28/2026 DS
`
`DP
`
`8703780
`
`12/28/2026
`
`Patent
`Use
`Code
`
`U-1684
`U-1946
`U-2241
`U-2242
`
`U-1650
`
`U-1456
`U-1650
`U-1946
`U-1947
`U-2241
`
`U-1456
`U-1491
`U-1650
`U-1946
`U-1947
`U-2241
`U-2242
`
`U-1491
`U-1650
`U-1946
`U-2241
`U-2242
`
`U-1491
`U-2242
`
`Delist
`Requested
`
`Submission
`Date
`
`07/17/2018
`
`07/17/2018
`
`08/02/2018
`
`10/26/2018
`
`11/16/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=003&Appl_No=210563&Appl_type=N
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`2/12/2019
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`003
`
`8735403
`
`12/28/2026 DS
`
`8754090
`
`06/03/2031
`
`8754091
`
`12/28/2026
`
`8952015
`
`12/28/2026
`
`DP
`
`DP
`
`8957079
`
`12/28/2026 DS
`
`DP
`
`8999999
`
`06/03/2031
`
`9125889
`
`06/03/2031
`
`9181257
`
`12/28/2026 DS
`
`9296753
`
`10/30/2033 DS
`
`9655857
`
`03/03/2036
`
`DP
`
`9725455
`
`06/03/2033 DS
`
`9795604
`
`10/24/2034
`
`9801881
`
`06/03/2031
`
`003
`
`9801883
`
`06/03/2031
`
`003
`
`9814721
`
`06/03/2031
`
`
`
`Patent
`Use
`Code
`
`U-1456
`
`U-1456
`U-1491
`U-1650
`U-1946
`U-1947
`U-2241
`U-2242
`
`U-1491
`U-1946
`U-2241
`U-2242
`
`U-1650
`
`U-2150
`
`U-1491
`U-2242
`
`U-2159
`U-2243
`
`U-1947
`
`Delist
`Requested
`
`Submission
`Date
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`03/06/2018
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=003&Appl_No=210563&Appl_type=N
`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`There is no unexpired exclusivity for this product in the Orange Book database.
`
`
`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=003&Appl_No=210563&Appl_type=N
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