`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`FDA Home3 Drug Databases‘ Orange Books
`
`Orange Book: Agproved Dru Products with Therapeutic Equivalence Evaiuations
`Orange Book Search esults on paten number '8859623' in the OB_Rx list.
`
`
`
`’ Code
`
`Claim
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`
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`5
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`5 Substance
`3 Claim
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`.8859623
`
`NOV 14, 2033
`
`8859623
`
`..
`
`'
`
`5
`
`N203510
`
`N203510
`
`
`i
`D01
`
`i002
`
`Additional information:
`
`PHENYLEPHRlNE
`HYDROCHLORIDE
`
`PHENYLEPHRINE
`HYDROCHLORIDE
`
`>NOV 14, 2033
`
`
`
`1. Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR 314.53(d)(5).
`2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor. These patents may not be
`flagged with respect to other claims which may apply.
`View a list of all patent use codes
`
`Retum to Electronic Orange Book Home Pages
`FDA/Center for Drug Evaluation and Research
`Office of Generic Dmgs
`Division of Labeling and Program Support
`Update Frequency:
`Orange Book Data - Monthly
`Generic Dmg Product Information & Patent Information - Daily
`Orange Book Data Updated Through March 2016
`Patent and Generic Drug Product Data Last Updated May 04, 2016
`
`Links on this page:
`1 . http:Jlwww.addthis.com/bookmark.php?u508=true&v=152&usemame=fdamain
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`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http:iIwww.fda.gov/Drugsil nformationOnDrugs/default.htm
`5. ../default.cfm
`
`6. ../default.cfm
`
`Note: if you need help accessing information in different file formats, see lnstmctions for Downloading Viewers and Players.
`Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website Policies
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Contact FDA
`
`E
`’T§a.,e~_.v.,.
`For Govemment For Press
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`
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`Combination Products Advisory Committees Science & Research Regulatory lnforrnation Safety Emergency Preparedness lntemational Programs News &
`Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive
`£ U.S.€!eper3:ment of fleaittz 8: Human Services
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php'?u508=tn.ie&v=152&usemame=fdamain
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`2. http://www.addthis.com/bookmark.php
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`3. http://www.fda.gov/default.htm
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`4. http://wwvv.fda.gov/Drugs/lnformationOnDnigs/defauithtm
`5. ../defaultcfm
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`6. ../default.cfm
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/newobpatcfm
`
`Page 1 of 5
`
`1/1
`
`Exhibit 1035, Page 1 of 5
`
`
`
`5/4/2016
`
`Oranm Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`FDA Home3 Drug Databases4 Orange Book5
`
`Oran e Book: Approved Drug Products with Therapeutic Equivalence Evaiuations
`Searc resuits from the "OB_Rx ' table for query on "203510."
`
`Active Ingredient:
`
`Dosage Form ;Route:
`
`Proprietary Name:
`
`Applicant:
`
`Strength:
`
`Application Number:
`Product Number:
`
`Approval Date:
`
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`
`PHENYLEPHRENE HYDROCHLORIDE
`
`SOLUTION/DROPS;OPHTHALMIC
`
`PHENYLEPHRINE HYDROCHLORIDE
`
`PARAGON BIOTECK
`
`2.5%
`
`N20351O
`001
`
`Mar 21, 2013
`
`Yes
`RX
`
`Patent and Exclusivity Info for this product: View
`
`Active Ingredient:
`
`Dosage Form;Route:
`
`Proprietary Name:
`
`Applicant:
`
`Strength:
`
`Application Number:
`Product Number:
`
`Approval Date:
`
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`
`PHENYLEPHRINE HYDROCHLORIDE
`
`SOLUTION/DROPS;OPHTHALMIC
`
`PHENYLEPHRINE HYDROCHLORIDE
`
`PARAGON BIOTECK
`
`1 0%
`
`N20351O
`002
`
`Mar 21, 2013
`
`Yes
`RX
`
`Patent and Exclusivity Info for this productzview
`
`Return to Electronic Orange Book Home Page5
`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeiing and Program Support
`Update Frequency:
`
`Orange Book Data — Monthly
`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through March 2016
`Patent and Generic Drug Product Data Last Updated May 04, 2016
`
`Links on this page:
`
`1 2 3 4
`
`. http://www.addthis.com/bookmark.php?uS08=true&v=152&username=fdamain
`
`. http://www.addthis.com/bookmark.php
`
`. http://www.fda.gov/default.htm
`
`. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5 6
`
`. ../default.cfm
`
`. ../default.cfm
`
`http://www.accessdata.fda.gov/scripts/cderlob/docs/obdetaiI.cfm'?Appl_No=203510&TABLE1=OB_Rx
`
`Exhibit 1035, Page 2 of 5
`
`1/2
`
`Exhibit 1035, Page 2 of 5
`
`
`
`5/4/2016
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading
`Viewers and Players.
`
`Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website
`Policies
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888—INFO—FDA (1-888-463-6332)
`Contact FDA
`
`
`For Government For Press
`
`Combination Products Advisory Committees Science & Research Regulatory Information Safety
`Emergency Preparedness International Programs News & Events Training and Continuing Education
`Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive
`U3. Eeparhrbeni of Haaltit 5: Human
`
`Links on this page:
`
`1 2 3 4
`
`. http://www.addthis.com/bookmark.php?u508=true&v=152&usemame=fdamain
`
`. http://www.addthis.com/bookmark.php
`
`. http://www.fda.gov/default.htm
`
`. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5.
`
`../default.cfm
`
`6 .
`
`../default.cfm
`
`http://www.accessdata.fda.govIscriptsloderlobldocslobdetail.cfm?Appl_No=203510&TABLE1=OB_Rx
`
`Exhlblt 1035, Page 3 Of 5
`
`2/2
`
`Exhibit 1035, Page 3 of 5
`
`
`
`5/4/2016
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`FDA Home?’ Drug Databases4 Orange Book5
`
`Oran e Book: Approved Drug Products with Therapeutic Equivalence Evaiuations
`Searc results from the "OB_Rx ' table for query on "203510."
`
`Active Ingredient:
`
`Dosage Form;Route:
`
`Proprietary Name:
`
`Applicant:
`
`Strength:
`
`Application Number:
`Product Number:
`
`Approval Date:
`
`Reference Listed Drug
`RX/OTC/DISCN :
`TE Code:
`
`PHENYLEPHRINE HYDROCHLORIDE
`
`SOLUTION/DROPS;OPHTHALMIC
`
`PHENYLEPHRINE HYDROCHLORIDE
`
`PARAGON BIOTECK
`
`2.5%
`
`N20351O
`001
`
`Mar 21, 2013
`
`Yes
`RX
`
`Patent and Exclusivity Info for this product: View
`
`Active Ingredient:
`
`Dosage Form ;Route:
`
`Proprietary Name:
`
`Applicant:
`
`Strength:
`
`Application Number:
`Product Number:
`
`Approval Date:
`
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`
`PHENYLEPHRINE HYDROCHLORIDE
`
`SOLUTION/DROPS;OPHTHALMIC
`
`PHENYLEPHRINE HYDROCHLORIDE
`
`PARAGON BIOTECK
`
`10%
`
`N203510
`002
`
`Mar 21, 2013
`
`Yes
`RX
`
`Patent and Exclusivity Info for this product: View
`
`Return to Electronic Orange Book Home Pages
`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
`Update Frequency:
`
`Orange Book Data - Monthly
`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through March 2016
`Patent and Generic Drug Product Data Last Updated May 04, 2016
`
`
`Links on this page:
`
`1 2 3 4
`
`. http://www.addthis.com/bookmark.php?uS08=true&v=152&username=fdamain
`
`. http://www.addthis.com/bookmark.php
`
`. http://www.fda.gov/default.htm
`
`. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5 6
`
`. ../defaultcfm
`
`.
`
`../default.cfm
`
`http:/Iwww.accessdata.fda.govlscripts/cderlob/docs/obdetail.cfm?App|_No=203510&TABLE1=0B_Rx
`
`Exhibit 1035, Page 4 of 5
`
`1/2
`
`Exhibit 1035, Page 4 of 5
`
`
`
`5/4/2016
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading
`Viewers and Players.
`
`Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website
`Policies
`<
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO—FDA ( 1-888-463-6332)
`
`
`
`For Government For Press
`
`Combination Products Advisory Committees Science & Research Regulatory Information Safety
`Emergency Preparedness International Programs News & Events Training and Continuing Education
`Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive
`3.5. Department of Haalfis xii.
`
`Links on this page:
`
`1 2 3 4
`
`. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`. http://www.addthis.com/bookmark.php
`
`. http://www.fda.gov/default.htm
`
`. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5.
`
`../default.cfm
`
`6 .
`
`../default.cfm
`
`htlp:llwww.accessdata.fda.gov/scripts/cderlob/docs/obdetail.cfm?App|_No=203510&TABLE1=OB_Rx
`
`Exhibit 1035, Page 5 of 5
`
`2/2
`
`Exhibit 1035, Page 5 of 5