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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
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`Home (default.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: N022527
`
`Product 001
`FINGOLIMOD (GILENYA) CAPSULE 0.5MG
`
`Patent Data
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`Claim
`
`Drug
`Product
`Claim
`
`Patent Use Code
`
`Delist
`Requested
`
`http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022527&Appl_type=N
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`001
`
`001
`
`001
`
`001
`
`5604229 Feb 18,
`2019
`
`DS
`
`6004565 Sep 23,
`2017
`
`8324283 Mar 29,
`2026
`
`9187405 Jun 25,
`2027
`
`Exclusivity Data
`
`U1086
`(show_code.cfm?
`id=1189&type=0)
`
`U1086
`(show_code.cfm?
`id=1189&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U1086
`(show_code.cfm?
`id=1189&type=0)
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`001
`
`NCE (show_code.cfm?id=1103&type=1)
`
`Sep 21, 2015
`
`View a list of all patent use codes (results_patent.cfm)
`View a list of all exclusivity codes (results_exclusivity.cfm)
`
`http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022527&Appl_type=N
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