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`Orange Book: Approved Drug
`Products with Therapeutic
`Equivalence Evaluations
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`CDERIOBIRESULTS PRODUCT.CFM?APPL TYPE=N&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
`
`Approval Date: Jan 30, 2015
`Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
`Marketing Status: Prescription
`
`inf9.-.9fm?fir99:
`extent
`Patentand Exclusivit mlnf9rmati9n
`
`'dct "'N'deéij'iélixggl MEL-2062mmgamiwtggeEN)
`
`https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type:N&Appl_...
`
`5/3/2018
`
`|PR2018—01020 and |PR2018—01021, Exhibit 1032, page1
`
`IPR2018-01020 and IPR2018-01021, Exhibit 1032, page1
`
`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`Page 1 of 2
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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
`(00(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: N206276
`
`Product 001
`
`OLOPATADINE HYDROCHLORIDE (PAZEO) SOLUTION/DROPS EQ 0.7% BASE
`
`Patent Data
`
`https://WWW.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No:001 &App1_N...
`
`5/8/2018
`
`|PR2018—01020 and |PR2018—01021, Exhibit 1032, page2
`
`IPR2018-01020 and IPR2018-01021, Exhibit 1032, page2
`
`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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`Page 2 of 2
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`Product Patent
`No
`No
`
`Use
`Drug
`Drug
`Patent
`Expiration Substance Product Code
`
`Delist
`Requested l
`
`Patent
`
`‘
`
`001
`
`001
`
`8791154 05/19/2032
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`9533053
`
`05/19/2032
`
`03’100‘0
`
`DP
`
`DP
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`001
`
`001
`
`(
`
`NE
`
`NP *PED
`
`01/30/2018
`
`07/30/2018
`
`View a list of all Qatent use codes (results Qatent.cfmz
`.cfm
`
`
`1
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`‘
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`)
`
`https://www.accessdata.fda. gov/soripts/cder/ob/patent_info.cfm?Product_No=00 l &Appl_N...
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`5/8/2018
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`|PR2018—01020 and |PR2018—01021, Exhibit 1032, page3
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`IPR2018-01020 and IPR2018-01021, Exhibit 1032, page3
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`