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`FDA Home3 Drug Databases4 Orange Book5
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Patent and Exclusivity Search Results from query on Appl No 022410 Product 001 in the OB_Rx list.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`N022410
`N022410
`N022410
`
`001
`001
`001
`
`8017150
`8475832
`8603514
`
`Patent
`Expiration
`Feb 13, 2023
`Mar 26, 2030
`Apr 3, 2024
`
`Exclusivity Data
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`Y
`Y
`Y
`
`U - 1411
`U - 1464
`
`Appl No
`
`Prod No
`
`Exclusivity Code
`
`N022410
`
`001
`
`NDF
`
`Exclusivity Expiration
`Aug 30, 2013
`
`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
`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 September 2014
`Patent and Generic Drug Product Data Last Updated November 06, 2014
`
`Links on this page:
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`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
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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`11/7/2014
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`Page 1
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`RB Ex. 2050
`BDSI v. RB PHARMACEUTICALS LTD
`IPR2014-00325
`
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`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 1 of 3
`
`FDA Home3 Drug Databases4 Orange Book5
`Orange Book: Approved Drug Products with Therapeutic Equivalence
`Evaluations
`Search results from the "OB_ Rx" table for query on "0 2 2 4 1 0 ."
`
`Active Ingredient:
`
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`Patent and Exclusivity Info for this
`product:
`
`Active Ingredient:
`
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`Patent and Exclusivity Info for this
`product:
`
`Active Ingredient:
`
`Dosage Form;Route:
`Proprietary Name:
`Applicant:
`Strength:
`Application Number:
`Product Number:
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`
`BUPRENORPHINE HYDROCHLORIDE; NALOXONE
`HYDROCHLORIDE
`FILM;SUBLINGUAL
`SUBOXONE
`RECKITT BENCKISER
`EQ 2MG BASE;EQ 0.5MG BASE
`N022410
`001
`Aug 30, 2010
`No
`RX
`
`View
`
`BUPRENORPHINE HYDROCHLORIDE; NALOXONE
`HYDROCHLORIDE
`FILM;SUBLINGUAL
`SUBOXONE
`RECKITT BENCKISER
`EQ 8MG BASE;EQ 2MG BASE
`N022410
`002
`Aug 30, 2010
`No
`RX
`
`View
`
`BUPRENORPHINE HYDROCHLORIDE; NALOXONE
`HYDROCHLORIDE
`FILM;SUBLINGUAL
`SUBOXONE
`RECKITT BENCKISER
`EQ 4MG BASE;EQ 1MG BASE
`N022410
`003
`Aug 10, 2012
`No
`RX
`
`file:///C:/Users/hum1/AppData/Local/Microsoft/Windows/Temporary%20Internet%20File...
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`11/7/2014
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`Page 2
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`
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of 3
`
`TE Code:
`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:
`Patent and Exclusivity Info for this
`product:
`
`BUPRENORPHINE HYDROCHLORIDE; NALOXONE
`HYDROCHLORIDE
`FILM;SUBLINGUAL
`SUBOXONE
`RECKITT BENCKISER
`EQ 12MG BASE;EQ 3MG BASE
`N022410
`004
`Aug 10, 2012
`Yes
`RX
`
`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 September 2014
`Patent and Generic Drug Product Data Last Updated November 06, 2014
`
`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.
`../default.cfm
`6.
`../default.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)
`
`file:///C:/Users/hum1/AppData/Local/Microsoft/Windows/Temporary%20Internet%20File...
`
`11/7/2014
`
`Page 3
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 3 of 3
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`Email 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
`
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`
`file:///C:/Users/hum1/AppData/Local/Microsoft/Windows/Temporary%20Internet%20File...
`
`11/7/2014
`
`Page 4
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