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`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
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`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: N203415
`
`Product 001
`ENZALUTAMIDE (XTANDI) CAPSULE 40MG
`
`Patent Data
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`Claim
`
`Drug
`Product
`Claim
`
`Patent
`Use
`Code
`
`Delis
`Requ
`
`001
`
`001
`
`7709517 Aug 13,
`2027
`
`8183274 May 15,
`2026
`
`DS
`
`DP
`
`U-1281
`U-1588
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=203415&Appl_type=N
`
`MYLAN PHARMS. INC. EXHIBIT 1133 PAGE 1
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`001
`
`9126941 May 15,
`2026
`
`U-1588
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`001
`
`001
`
`I-693
`
`NCE
`
`Sep 10, 2017
`
`Aug 31, 2017
`
`View a list of all patent use codes
`View a list of all exclusivity codes
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=203415&Appl_type=N
`
`MYLAN PHARMS. INC. EXHIBIT 1133 PAGE 2
`
`