Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 1 of 1
`
`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 020622 Product 003 in the OB_Rx list.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`N020622
`N020622
`
`003
`003
`
`8232250
`8399413
`
`Patent
`Expiration
`Aug 19, 2030
`Aug 19, 2030
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Delist
`Requested
`
`Patent Use
`Code
`U - 441
`U - 441
`
`Exclusivity Data
`
`Appl No
`
`Prod No
`
`Exclusivity Code
`
`N020622
`
`003
`
`NP
`
`Exclusivity Expiration
`Jan 28, 2017
`
`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 December 2014
`Patent and Generic Drug Product Data Last Updated January 29, 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.
`../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)
`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
`
`Links on this page:
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020622&P...
`
`1/29/2015
`
`MYLAN PHARMS. INC. EXHIBIT 1063 PAGE 1
`
`
`
`Page 1 of 1
`
`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 020622 Product 003 in the OB_Rx list.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`N020622
`N020622
`
`003
`003
`
`8232250
`8399413
`
`Patent
`Expiration
`Aug 19, 2030
`Aug 19, 2030
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Delist
`Requested
`
`Patent Use
`Code
`U - 441
`U - 441
`
`Exclusivity Data
`
`Appl No
`
`Prod No
`
`Exclusivity Code
`
`N020622
`
`003
`
`NP
`
`Exclusivity Expiration
`Jan 28, 2017
`
`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 December 2014
`Patent and Generic Drug Product Data Last Updated January 29, 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.
`../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)
`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
`
`Links on this page:
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020622&P...
`
`1/29/2015
`
`MYLAN PHARMS. INC. EXHIBIT 1063 PAGE 1
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 1 of 2
`
`FDA H ome3 Drug Databases4 Orange Book5
`Orange Book:Approved Drug Products with TherapeuticEquivalence
`Evaluations
`Search results from the "OB_Rx" table for query on "020622."
`
`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: View
`
`GLATIRAMER ACETATE
`INJECTABLE;SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`20MG/ML
`N020622
`002
`Feb 12, 2002
`Yes
`RX
`
`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: View
`
`GLATIRAMER ACETATE
`INJECTABLE;SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`40MG/ML
`N020622
`003
`Jan 28, 2014
`Yes
`RX
`
`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 December 2014
`Patent and Generic Drug Product Data Last Updated January 29, 2015
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?
`u508=true&v=152&username=fdamain
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020622&TAB...
`
`1/29/2015
`
`MYLAN PHARMS. INC. EXHIBIT 1063 PAGE 2
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of 2
`
`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)
`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
`
`Links on this page:
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020622&TAB...
`
`1/29/2015
`
`MYLAN PHARMS. INC. EXHIBIT 1063 PAGE 3
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 1 of 2
`
`FDA H ome3 Drug Databases4 Orange Book5
`Orange Book:Approved Drug Products with TherapeuticEquivalence
`Evaluations
`Search results from the "OB_Rx" table for query on "020622."
`
`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: View
`
`GLATIRAMER ACETATE
`INJECTABLE;SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`20MG/ML
`N020622
`002
`Feb 12, 2002
`Yes
`RX
`
`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: View
`
`GLATIRAMER ACETATE
`INJECTABLE;SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`40MG/ML
`N020622
`003
`Jan 28, 2014
`Yes
`RX
`
`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 December 2014
`Patent and Generic Drug Product Data Last Updated January 29, 2015
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?
`u508=true&v=152&username=fdamain
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020622&TAB...
`
`1/29/2015
`
`MYLAN PHARMS. INC. EXHIBIT 1063 PAGE 4
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of 2
`
`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)
`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
`
`Links on this page:
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020622&TAB...
`
`1/29/2015
`
`MYLAN PHARMS. INC. EXHIBIT 1063 PAGE 5
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 1 of 2
`
`FDA H ome3 Drug Databases4 Orange Book5
`Orange Book:Approved Drug Products with TherapeuticEquivalence
`Evaluations
`Search results from the "OB_Rx" table for query on "020622."
`
`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: View
`
`GLATIRAMER ACETATE
`INJECTABLE;SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`20MG/ML
`N020622
`002
`Feb 12, 2002
`Yes
`RX
`
`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: View
`
`GLATIRAMER ACETATE
`INJECTABLE;SUBCUTANEOUS
`COPAXONE
`TEVA PHARMS USA
`40MG/ML
`N020622
`003
`Jan 28, 2014
`Yes
`RX
`
`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 December 2014
`Patent and Generic Drug Product Data Last Updated January 29, 2015
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?
`u508=true&v=152&username=fdamain
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020622&TAB...
`
`1/29/2015
`
`MYLAN PHARMS. INC. EXHIBIT 1063 PAGE 6
`
`
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Page 2 of 2
`
`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)
`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
`
`Links on this page:
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020622&TAB...
`
`1/29/2015
`
`MYLAN PHARMS. INC. EXHIBIT 1063 PAGE 7
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