3/9/2015
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`FDA Home3 Drug Databases4 Orange Book5
`
`Oran e Book: Approved Drug Products with Thera eutic Equivalence Evaluations
`Searc results from the "OB_Rx ' table for query on "2 3565."
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`
`FERRIC CARBOXYMALTOSE
`INJECTABLE;INTRAVENOUS
`INJECTAFER
`LUITPOLD
`750MG IRON/15ML (50MG IRON/ML)
`N203565
`001
`
`Jul 25, 2013
`Yes
`RX
`
`Patent and Exclusivity Info for this product: View
`
`Return to Electronic Orange Book Home Page5
`
`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 January 2015
`Patent and Generic Drug Product Data Last Updated March 06, 2015
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5.
`
`6.
`
`../defau|t.cfm
`
`../defau|t.cfm
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading
`Viewers and Players.
`
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`Email FDA
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`*
`
`D E E .'-‘.
`
`http://www.acoessdata.fda.gov/scripts/cder/ob/docs/obdetai|.cfm ?App|_N o=203565&TABLE1=OB_Rx
`
`Pharmacosmos, Exh. 1019, p. 1
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`FDA Home3 Drug Databases4 Orange Book5
`
`Oran e Book: Approved Drug Products with Thera eutic Equivalence Evaluations
`Searc results from the "OB_Rx ' table for query on "2 3565."
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`
`FERRIC CARBOXYMALTOSE
`INJECTABLE;INTRAVENOUS
`INJECTAFER
`LUITPOLD
`750MG IRON/15ML (50MG IRON/ML)
`N203565
`001
`
`Jul 25, 2013
`Yes
`RX
`
`Patent and Exclusivity Info for this product: View
`
`Return to Electronic Orange Book Home Page5
`
`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 January 2015
`Patent and Generic Drug Product Data Last Updated March 06, 2015
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5.
`
`6.
`
`../defau|t.cfm
`
`../defau|t.cfm
`
`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)
`Email FDA
`
`*
`
`D E E .'-‘.
`
`http://www.acoessdata.fda.gov/scripts/cder/ob/docs/obdetai|.cfm ?App|_N o=203565&TABLE1=OB_Rx
`
`Pharmacosmos, Exh. 1019, p. 1
`
`
`
`3/9/2015
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`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
`g U.5.Departn1-ant Crf Health & Human Services
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`2 3 4
`
`5 6
`
`. http://www.addthis.com/bookmark.php
`
`. http://www.fda.gov/default.htm
`
`. http://www.fda.gov/Drugs/I nformationOnDrugs/default.htm
`
`.
`
`.
`
`../defau|t.cfm
`
`../defau|t.cfm
`
`http://www.acoessdata.fda.gov/scripts/cder/ob/docs/obdetai|.cfm ?App|_N o=203565&TABLE1=OB_Rx
`
`Pharmacosmos, Exh. 1019, p. 2
`
`
`
`3/9/2015
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`FDA Home3 Drug Databases4 Orange Book5
`
`Orange Book: Apgroved Dru Products with Thera eutic Etauivalence Evaluations
`Patent and Exclusivity earch Results rom query on Appl No 2035 5 Product 01 in the OB_Rx list.
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`N203565
`N203565
`N203565
`
`7612109
`7754702
`8895612
`
`Patent
`Expiration
`Feb 5, 2024
`Feb 13, 2027
`Jan 8, 2027
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Y
`
`Delist
`Requested
`
`Exclusivity Data
`
`Appl No
`
`N203565
`
`Additional information:
`
`Exclusivity Code
`
`Exclusivity Expiration
`Jul 25, 2016
`
`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
`View a list of all exclusivity codes
`
`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 Dmg Product Infonnation & Patent lnforrnation - Daily
`Orange Book Data Updated Through January 2015
`Patent and Generic Drug Product Data Last Updated March 06, 2015
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&usemame=fdamain
`
`. http://wvvw.addthis.com/bookmark.php
`
`. http://wvvw.fda.gov/default.htm
`
`2 3 4
`
`. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`.
`../defau|t.cfm
`
`../defau|t.cfm
`
`5 6
`
`.
`
`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-I N FO-FDA (1 -888463-6332)
`Email FDA
`
`D E .-9'.
`'F|~"':‘='_-\.-L312-,a._ "
`For Government For Press
`
`Combination Products Advisory Committees Science & Research Regulatory lnforrnation Safety Emergency Preparedness International Programs News &
`Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive
`f LL5. Depar‘l:rnent of Health & Human Sarlicfi
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&usemame=fdamain
`
`2. http://www.addthis.com/bookmark.php
`
`htlp://www.accessdata.fda.gov/scri pts/cder/ob/docs/patexcl new .cfm?App|_N o= 203565&Product_N o=001&tab|e1 =OB_Rx
`
`Pharmacosmos, Exh. 1019, p. 3
`
`
`
`3/9/2015
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`. http://www.fda.gov/default.htm
`
`. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`.
`../defau|t.cfm
`
`.
`
`../defau|t.cfm
`
`htlp://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm’?App|_No=203565&Product_No=001&table1=OB_Rx
`
`Pharmacosmos, Exh. 1019, p. 4
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