`
`Page 1 of 2
`
`Orange Book: Approved Drug
`Products with Therapeutic
`Equivalence Evaluations
`
`(cid:1) 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=202514&APPL_TYPE=N)
`
`(cid:2) TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERA
`PEUTIC EQUIVALENCE EVALUATIONS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.
`CFM?PRODUCT_NO=001&APPL_NO=202514&APPL_TYPE=N)
`
`+ (cid:4)
`
`EMAIL (MAILTO:?SUBJECT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVA
`LUATIONS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?PRODUCT_NO=001&A
`PPL_NO=202514&APPL_TYPE=N)
`
`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: N202514
`
`Product 001
`TAFLUPROST (ZIOPTAN) SOLUTION/DROPS 0.0015%
`
`Patent Data
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_...
`
`5/11/2017
`
`Micro Labs Exhibit 1017
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of 2
`
`Product
`No
`
`Patent
`No
`
`Patent
`Expiration
`
`Drug
`Substance
`Claim
`
`Drug
`Product
`Claim
`
`Patent Use Code
`
`Delist
`Requested
`
`001
`
`5886035 Dec 18,
`2022
`
`DS
`
`DP
`
`U-778
`(show_code.cfm?
`id=619&type=0)
`
`Exclusivity Data
`
`Product
`No
`
`001
`
`Exclusivity Code
`
`NCE (show_code.cfm?
`id=1112&type=1)
`
`Exclusivity
`Expiration
`
`Feb 10, 2017
`
`
`
`
`
`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_...
`
`5/11/2017
`
`Micro Labs Exhibit 1017-2
`
`