`
`http://www.accessdatafda. gov/scripts/cder/ob/docs/obdetai1.cfm?App1_...
`
`FDA Protectin and Promotin Your Health
`
`US. Food and Drug Administration
`
`FDA Home3 Drug Databases4 Orange Book5
`
`Orange Book: Approved Drug Products with Th__6gpeutic Equivalence Evaluations
`Searc results fro
`the "OB_Rx table for query on
`695."
`
`Active Ingredient:
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`
`FENOFIBRATE
`CAPSULE;ORAL
`ANTARA (MICRONIZED)
`LUPIN ATLANTIS
`43MG
`N021695
`001
`
`Nov 30, 2004
`No
`RX
`AB
`
`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:
`
`FENOFIBRATE
`CAPSULE;ORAL
`ANTARA (MICRONIZED)
`LUPIN ATLANTIS
`130MG
`N021695
`003
`
`Nov 30, 2004
`Yes
`RX
`AB
`
`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:
`
`FENOFIBRATE
`CAPSULE;ORAL
`ANTARA (MICRONIZED)
`LUPIN ATLANTIS
`30MG
`N021695
`004
`
`Oct 18, 2013
`No
`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:
`
`1of2
`
`FENOFIBRATE
`CAPSULE;ORAL
`ANTARA (MICRONIZED)
`LUPIN ATLANTIS
`90MG
`N021695
`005
`
`Oct 18, 2013
`No
`RX
`
`7/15/2015 10:13 PM
`
`Janssen Ex. 2035
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`lPR2015-01030
`
`(Page 1 of 2)
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`
`http://www.accessdatafda. gov/scripts/cder/ob/docs/obdetai1.cfm?App1_...
`
`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 May 2015
`Patent and Generic Drug Product Data Last Updated July 15, 2015
`
`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/defau|t.htm
`
`. http://www.fda.gov/Drugs/InformationOnDrugs/defau|t.htm
`
`5. ../defau|t.cfm
`
`6 . ../defau|t.cfm
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewer:
`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
`
`m E Q 55 “
`1'5‘-9.0-'
`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.S. Department of Health Sc Human Services
`
`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/defau|t.htm
`
`. http://www.fda.gov/Drugs/InformationOnDrugs/defau|t.htm
`
`5. ../defau|t.cfm
`
`6 . ../defau|t.cfm
`
`2 of2
`
`7/15/2015 10:13 PM
`
`Janssen Ex. 2035
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 2 of 2)