`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 methodofuse 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: N203634
`
`Product 001
`BUDESONIDE (UCERIS) TABLET, EXTENDED RELEASE 9MG
`
`Patent Data
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`Claim
`
`Drug
`Product
`Claim
`
`Patent Use Code
`
`Delist
`Requested
`
`Exhibit 1060
`ARGENTUM
`IPR2018-00080
`
`000001
`
`
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`7410651 Jun 9,
`2020
`
`7431943 Jun 9,
`2020
`
`8293273 Jun 9,
`2020
`
`8784888 Jun 9,
`2020
`
`8895064 Sep 7,
`2031
`
`9132093 Sep 7,
`2031
`
`9192581 Sep 7,
`2031
`
`9320716 Jun 9,
`2020
`
`9532954 Jun 9,
`2020
`
`RE43799 Jun 9,
`2020
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`U1325
`(show_code.cfm?
`id=1325&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U1325
`(show_code.cfm?
`id=1325&type=0)
`
`U1325
`(show_code.cfm?
`id=1325&type=0)
`
`U1325
`(show_code.cfm?
`id=1325&type=0)
`
`U1325
`(show_code.cfm?
`id=1325&type=0)
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`There is no unexpired exclusivity for this product in the Orange Book database.
`
`000002
`
`