`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`- - - - - -
`
`IIE:=\VA U.S. Food and Drug Administrati'on
`Irl!:!:lV~ Protect in g and Promotl ng Your Hea It ll
`FDA Home3 Drug Databases4 Orange BookS
`Orange Book: Approved Dru~ Products with Therapeutic Equivalence Evaluations
`SearcTl results from the "OB_RX ' table for query on "021462."
`
`PEMETREXED DISODIUM
`INJECTABLE;IV (INFUSION)
`ALIMTA
`LILLY
`EQ 500MG BASEjVIAL
`N021462
`001
`Feb 4,2004
`Yes
`RX
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`Approval Date:
`Reference Listed Drug
`RXjOTCjDISCN :
`TE Code:
`Patent and Exclusivity Info for this product: View
`Active Ingredient:
`PEMETREXED DISODIUM
`INJECTABLE;IV (INFUSION)
`Dosage Form;Route:
`Proprietary Name:
`ALIMTA
`LILLY
`Applicant:
`Strength:
`EQ 100MG BASEjVIAL
`N021462
`Application Number:
`002
`Product Number:
`Sep 7, 2007
`Approval Date:
`Reference Listed Drug
`Yes
`RXjOTCjDISCN :
`RX
`TE Code:
`Patent and Exclusivity Info for this product: View
`Return to Electronic Orange Book Home Page6
`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 October 2015
`Patent and Generic Drug Product Data Last Updated December 11, 2015
`
`Links on this page:
`1. http://www.addthis.com/bookmark. php?u508=true&v= 152&username=fdamai n
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5.
`
`. ./default.cfm
`
`6.
`
`. ./default.cfm
`
`http://www .accessdata.fda.gov/scri pts/cder/ob/docs/obdetail.cfm?Appl_No=021462& T ABLE1 = OB_Rx
`
`1/2
`
`Sandoz Inc.
`Exhibit 1054-0001
`
`Teva – Fresenius
`Exhibit 1053-00001
`
`
`
`12114/2015
`
`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
`
`4= u.s. Department of H @a lth8t Huma n St!irvices
`
`Links on this page:
`1. http://www.addthis.com/bookmark. php?u508=true&v= 152&username=fdamai n
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5.
`
`. ./default.cfm
`
`6.
`
`. ./default.cfm
`
`http://www .accessdata.fda.gov/scri pts/cder/ob/docs/obdetail.cfm?Appl_No=021462& T ABLE1 = OB_Rx
`
`212
`
`Sandoz Inc.
`Exhibit 1054-0002
`
`Teva – Fresenius
`Exhibit 1053-00002
`
`
`
`12114/2015
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`re::=\VA U.S. Food and Drug Administration
`IFI!:::!IV~ Protecting and Promoting Your Hea lt h
`FDA Home3 Drug Databases4 Orange Book5
`Orange Book: Approved DruQ Products with Therapeutic Equivalence Evaluations
`Patent and ExclusivitY Search Resultsr rom query on Appl No 0214G2 Product 001 in the OB_Rx list.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`Patent
`Expiration
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`N021462
`
`N021462
`
`N021462
`
`N021462
`
`N021462
`
`001
`
`001
`
`001
`
`001
`
`001
`
`Exclusivity Data
`
`5344932
`
`Jul 24, 2016
`
`y
`
`5344932*PED
`
`Jan 24,2017
`
`7772209
`
`7772209
`
`Nov 24,2021
`
`Nov 24,2021
`
`7772209*PED
`
`May 24,2022
`
`y
`
`l
`
`I
`
`I
`
`U -1077
`
`U -1296
`
`L
`
`Appl No
`
`Prod No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`N021462
`
`N021462
`
`001
`
`001
`
`PED
`
`M -122
`
`Sep 17, 2014
`
`Oct 17,2015
`
`Additional information:
`
`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
`Retum to Electronic Orange Book Home Page6
`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 October 2015
`Patent and Generic Drug Product Data Last Updated December 11, 2015
`
`Links on this page:
`1. http://www.addthis.com/bookmark. php?u508=true&v= 152&usemame=fdamai n
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.govlDrugs/lnformationOnDrugs/default.htm
`
`5. ..Idefault.cfm
`
`6. ..Idefault.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. 1-888-1 N FO-FDA (1-888-463-6332)
`Contact FDA
`
`For Govemment For Press
`Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness Intemational Programs News &
`Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive
`
`<If: u.s. Departmeml of H .. "ltIJ &: Hum"n Services
`
`http://www.accessdata.fda.gov/scri pts/cder /ob/docs/patexcl new .cfm ?Appl_ N 0=021462&Product_ N 0= 001 &tabl e1 = OB _ Rx
`
`1/2
`
`Sandoz Inc.
`Exhibit 1054-0003
`
`Teva – Fresenius
`Exhibit 1053-00003
`
`
`
`12114/2015
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Links on this page:
`1. http://www.addthis.com/bookmark. php?u508=true&v= 152&usemame=fdamai n
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.govlDrugs/lnformationOnDrugs/default.htm
`
`5.
`
`..Idefault.cfm
`
`6.
`
`..Idefault.cfm
`
`http://www.accessdata.fda.gov/scri pts/cder /ob/docs/patexcl new .cfm ?Appl_ N 0=021462&Product_ N 0= 001 &tabl e1 = OB _ Rx
`
`212
`
`Sandoz Inc.
`Exhibit 1054-0004
`
`Teva – Fresenius
`Exhibit 1053-00004