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`Orange Book: Approved Drug
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`CDER/OB/RESULTS PRODUCT.CFM?APPL_TYPE=N&APPL_NO=206276)
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`&APPL_NO=206276)
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`
`Product Details for NDA 206276
`
`PAZEO (OLOPATADINE HYDROCHLORIDE)
`EQ 0.7% BASE
`
`Marketing Status: Prescription
`
`Active Ingredient: OLOPATADINE HYDROCHLORIDE
`Proprietary Name: PAZEO
`Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
`Strength: EQ 0.7% BASE
`Reference Listed Drug: Yes
`Reference Standard: Yes
`TE Code:
`Application Number: N206276
`Product Number: 001
`ApprovalDate: Jan 30, 2015
`Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
`Marketing Status: Prescription
`(patent _info.cfm?Prod-
`Patent and Exclusivity Information
`
`uct No=001&Appl_No=206276&Appl_type=N)
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_...
`
`5/3/2018
`
`IPR2018-01020 and IPR2018-01021, Exhibit 1032, page1
`
`IPR2018-01020 and IPR2018-01021, Exhibit 1032, page1
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`Orange Book: Approved Drug
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`PPL_NO=2062768APPL_TYPE=N)
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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.
`
`e
`
`As of December 5, 2016, an NDA holder submitting information on a patent that claims both
`the drug substance and the drug product(andis 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 patentlisting, regardless of whenfirst published, to
`determine the range of patent claims that may be asserted by an NDAholder or patent
`owner.
`
`Patent and Exclusivity for: N206276
`
`Product 001
`OLOPATADINE HYDROCHLORIDE (PAZEO) SOLUTION/DROPSEQ 0.7% BASE
`
`Patent Data
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_N...
`
`5/8/2018
`
`IPR2018-01020 and IPR2018-01021, Exhibit 1032, page2
`
`IPR2018-01020 and IPR2018-01021, Exhibit 1032, page2
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`Page 2 of 2
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`Patent
`Patent
`Drug
`Drug
`Use
`Product Patent
`Expiration Substance Product Code
`No
`No
`001
`8791154 05/19/2032
`DP
`U-1680
`001
`9533053
`05/19/2032
`DP
`
`|
`Delist
`|
`Requested |
`|
`|
`
`Exclusivity Data
`Product No
`001
`001
`
`Exclusivity Code
`NP
`NP *PED
`
`Exclusivity Expiration
`01/30/2018
`07/30/2018
`
`|
`|
`|
`|
`
`>
`
`Viewalist of all patent use codes (results patent.cfm)
`Viewalist of all exclusivity codes (results _exclusivi
`
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_N...
`
`5/8/2018
`
`IPR2018-01020 and IPR2018-01021, Exhibit 1032, page3
`
`IPR2018-01020 and IPR2018-01021, Exhibit 1032, page3
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`€
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