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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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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 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: N050790
`
`Product 001
`CYCLOSPORINE (RESTASIS) EMULSION 0.05%
`
`Patent Data
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`Claim
`
`Drug
`Product
`Claim
`
`Patent Use Code
`
`Delist
`Requested
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=050790&Appl_type=N
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`MYLAN - EXHIBIT 1069
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
`
`
`
`6/21/2017
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`8629111 Aug 27,
`2024
`
`8633162 Aug 27,
`2024
`
`8642556 Aug 27,
`2024
`
`8648048 Aug 27,
`2024
`
`8685930 Aug 27,
`2024
`
`9248191 Aug 27,
`2024
`
`
`
`Exclusivity Data
`
`DP
`
`DP
`
`DP
`
`(show_code.cfm?
`id=&type=0)
`
`U1479
`(show_code.cfm?
`id=1549&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U1483
`(show_code.cfm?
`id=1595&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U1479
`(show_code.cfm?
`id=1549&type=0)
`
`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)
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