`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
` SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?
`U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?PRODUCT_NO=001&APPL_NO=021995&APPL_TYPE=N)
`
` TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC
`EQUIVALENCE EVALUATIONS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?
`PRODUCT_NO=001&APPL_NO=021995&APPL_TYPE=N)
`
`
`
`EMAIL (MAILTO:?SUBJECT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE
`EVALUATIONS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?
`PRODUCT_NO=001&APPL_NO=021995&APPL_TYPE=N)
`
`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: N021995
`
`Product 001
`SITAGLIPTIN PHOSPHATE (JANUVIA) TABLET EQ 25MG BASE
`
`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=001&Appl_No=021995&Appl_type=N
`
`1/2
`
`1 of 2
`
`IPR2020-01045
`Teva Ex. 1009
`
`
`
`7/22/2019
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`
`Drug
`Product
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`6699871 07/26/2022 DS
`
`DP
`
`6890898 02/02/2019
`
`7078381 02/02/2019
`
`7125873 07/26/2022
`
`7326708 11/24/2026 DS
`
`DP
`
`7459428 02/02/2019
`
`Patent
`Use
`Code
`
`U-774
`
`U-1997
`
`U-1997
`
`U-775
`U-1036
`U-1037
`U-1038
`
`U-802
`
`U-1945
`
`Delist
`Requested
`
`Submission
`Date
`
`01/18/2017
`
`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=001&Appl_No=021995&Appl_type=N
`
`2/2
`
`2 of 2
`
`IPR2020-01045
`Teva Ex. 1009
`
`
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