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`Page 1 of 2
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`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: N207620
`
`Product 001
`SACUBITRIL; VALSARTAN (ENTRESTO) TABLET 24MG;26MG
`
`Patent Data
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_...
`
`7/29/2020
`
`BIOCON PHARMA LTD (IPR2020-01263) Ex. 1017, p. 001
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of 2
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`Product
`No
`
`Patent No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`Patent
`Use
`Code
`
`Delist
`Requested
`
`Submission
`Date
`
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`001
`
`11/27/2023
`7468390
`7468390*PED 05/27/2024
`8101659
`01/14/2023
`8101659*PED 07/14/2023
`8404744
`01/14/2023
`8404744*PED 07/14/2023
`8796331
`01/14/2023
`8796331*PED 07/14/2023
`8877938
`05/27/2027
`8877938*PED 11/27/2027
`9388134
`11/08/2026
`9388134*PED 05/08/2027
`
`DP
`
`DP
`
`DP
`
`08/06/2015
`
`08/06/2015
`
`08/06/2015
`
`U-1723
`
`08/06/2015
`
`DS
`
`DP
`
`08/06/2015
`
`U-1723
`
`09/07/2016
`
`Exclusivity Code
`NCE
`
`NCE *PED
`
`NPP
`
`NPP *PED
`
`Exclusivity Expiration
`07/07/2020
`
`01/07/2021
`
`10/01/2022
`
`04/01/2023
`
`Exclusivity Data
`
`Product No
`001
`
`001
`
`001
`
`001
`
`
`
`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_...
`
`7/29/2020
`
`BIOCON PHARMA LTD (IPR2020-01263) Ex. 1017, p. 002
`
`