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`Page 1 of 1
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`Orange Book: Approved Drug
`Products with Therapeutic
`Equivalence Evaluations
`
`f SHARE IHTTPS:llWWW.FACEBOOK.COM/SHARERISHARER.PHP?U=HTTPS:INVWW.ACCESSDATA.FDA.GOVISCRIPTSI
`
`CDERIOBIRESULTS PRODUCT.CFM?APPL TYPE=N&APPL N0=206276)
`
`' TWEET HTTPS:IITWITTER.COMIINTENT/TWEETI?TEXT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERA
`
`PEUTIC E UIVALENCE EVALUATIONS&URL=H1TPS:IIWWW.ACCESSDATA.FDA.GOVISCRIPTS/CDER/OBIRESULTS PRO
`
`DUCT.CFM?APPL TYPE=N&APPL NO=206276)
`
`i !
`
`EMAIL (MAILTO:?SUBJECT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTTC EQUIVALENCE EVA
`LUAT10NS&BODY=HTTPS:IIWWW.ACCESSDATA.FDA.GOVISCRIPTS/CDER/OB/RESULTS PRODUCT.CFM?APPL TYPE=N
`&APPL NO=206276)
`
`Home (index.cfm?resetfields=1I 1 Back to Search Results
`
`Product Details for NBA 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: E0 07% 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
`
`Information.
`Patent and Exclusivit
`
`'u'ct "'N'b='66"1mé{)&ggl No=2062768A99|
`
`atent inf9.-.9f.m?Rr99:
`tygeé'N)
`
`https://www.accessdata.fda.gov/scripts/Cder/ob/results_product.cfm?Appl_Type:N&Appl_...
`
`5/3/2018
`
`Ayla Pharma LLC (IPR2020-00295) EX. 1032 p. 001
`
`Ayla Pharma LLC (IPR2020-00295) Ex. 1032 p. 001
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 1 of 2
`
`Orange Book: Approved Drug
`Products with Therapeutic
`Equivalence Evaluations
`
`f SHARE HTTPS:l/WWW.FACEBOOK.COM/SHARERISHARER.PHP?U=HTTPS:INVWW.ACCESSDATA.FDA.GOVISCRIPTS/
`CDER/OBIPATENT INFO.CFM?PRODUCT NO=001&APPL NO=206276&APPL TYPE=N
`
`’ TWEET HTTPSIIITWITTER.COMIINTENT/TWEETI?TEXT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERA
`
`PEUTIC E UIVALENCE EVALUATIONS8URL=HTTPS:/NVWW.ACCESSDATA.FDA.GOVISCRIPTS/CDERIOB/PATENT INFO.
`
`CFM?PRODUCT NO=001&APPL NO=206276&APPL TYPE=N
`
` i a
`
`EMAIL (MAILTO:?SUBJECT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVA
`LUATIONS&BODY=HTTPS:IIWWW.ACCESSDATA.FDA.GOVISCRIPTS/CDER/OB/PATENT |NFO.CFM?PRODUCT NO=001&A
`PPL NO=206276&APPL TYPE=N]
`
`Home ‘index.cfm?resetfields=1 i | 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 NBA 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 NBA 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
`
`Ayla Pharma LLC (IPR2020-00295) EX. 1032 p. 002
`
`Ayla Pharma LLC (IPR2020-00295) Ex. 1032 p. 002
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of 2
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`Product Patent
`No
`No
`
`Patent
`Use
`Drug
`Drug
`Patent
`Expiration Substance Product Code
`
`E
`E
`Delist
`Requested El
`
`001
`001
`
`8791154 05/19/2032
`9533053
`05/19/2032
`
`011000
`
`DP
`DP
`
`Exclusivity Data
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`001
`
`001
`
`<
`
`NE
`
`01/30/2018
`
`NP *PED
`
`07/30/2018
`
`‘
`E
`
`5
`
`5
`
`E
`
`.>,
`
`View a list of all patent use codes (results patentcfm)
`Viewa list of all exclusivit codes results exclusivi
`.cfm
`
`
`https://www.accessdata.tda.gov/scripts/cder/ob/patent_info.cfm?Product_No=00 1&Appl_N...
`
`5/8/2018
`
`Ayla Pharma LLC (IPR2020-00295) EX. 1032 p. 003
`
`Ayla Pharma LLC (IPR2020-00295) Ex. 1032 p. 003
`
`
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