`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
` SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?
`U=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?PRODUCT_NO=001&APPL_NO=022511&APPL_TYPE=N)
`
` TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE
`EVALUATIONS&URL=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?
`PRODUCT_NO=001&APPL_NO=022511&APPL_TYPE=N)
`
`
`
`EMAIL (MAILTO:?SUBJECT=ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE
`EVALUATIONS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/OB/PATENT_INFO.CFM?
`PRODUCT_NO=001&APPL_NO=022511&APPL_TYPE=N)
`
`Home (default.cfm?resetfields=1) | Back to Product Details
`
`Additional Information about Patents
`
`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).
`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.
`
`Patent and Exclusivity for: N022511
`
`Product 001
`ESOMEPRAZOLE MAGNESIUM; NAPROXEN (VIMOVO) TABLET, DELAYED RELEASE EQ
`20MG BASE;500MG
`
`Patent Data
`
`Product
`No
`
`001
`
`Patent No
`
`Patent
`Expiration
`
`Drug
`Substance
`Claim
`
`Drug
`Product
`Claim
`
`5714504*PED Aug 3,
`2015
`
`Delist
`Requested
`
`Patent Use Code
`
`(show_code.cfm?
`id=&type=0)
`
`http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022511&Appl_type=N
`
`1/3
`
`CFAD EXHIBIT 1036
`CFAD v. Pozen
`IPR2015-01718
`
`
`
`Delist
`Requested
`
`9/26/2016
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product
`No
`
`Patent No
`
`Patent
`Expiration
`
`Drug
`Substance
`Claim
`
`Drug
`Product
`Claim
`
`001
`
`5900424
`
`May 4,
`2016
`
`DS
`
`001
`
`5900424*PED Nov 4,
`2016
`
`001
`
`6369085
`
`May 25,
`2018
`
`DS
`
`DP
`
`001
`
`6369085*PED Nov 25,
`2018
`
`001
`
`6926907
`
`Feb 28,
`2023
`
`001
`
`7411070
`
`May 25,
`2018
`
`DS
`
`001
`
`7411070*PED Nov 25,
`2018
`
`001
`
`7745466
`
`001
`
`8557285
`
`001
`
`8852636
`
`001
`
`8858996
`
`001
`
`8945621
`
`Oct 13,
`2018
`
`May 31,
`2022
`
`May 31,
`2022
`
`May 31,
`2022
`
`Oct 17,
`2031
`
`DP
`
`DP
`
`DP
`
`DP
`
`DP
`
`Patent Use Code
`
`U1053
`(show_code.cfm?
`id=1156&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U1053
`(show_code.cfm?
`id=1156&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U1052
`(show_code.cfm?
`id=1155&type=0)
`
`U1053
`(show_code.cfm?
`id=1156&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U1053
`(show_code.cfm?
`id=1156&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U1052
`(show_code.cfm?
`id=1155&type=0)
`
`U1052
`(show_code.cfm?
`id=1155&type=0)
`
`U1661
`(show_code.cfm?
`id=1638&type=0)
`
`http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022511&Appl_type=N
`
`2/3
`
`
`
`9/26/2016
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`Product No
`Product
`No
`
`Patent No
`
`Exclusivity Code
`Patent
`Expiration
`
`Drug
`Substance
`Claim
`
`
`DrugExclusivity Expiration
`Product
`Claim
`
`Patent Use Code
`
`Delist
`Requested
`
`May 31,
`2022
`
`May 31,
`2022
`
`Mar 10,
`2031
`
`May 31,
`2022
`
`Sep 3,
`2029
`
`001
`
`9161920
`
`001
`
`9198888
`
`001
`
`9220698
`
`001
`
`9345695
`
`001
`
`9393208
`
`Exclusivity Data
`
`U1760
`(show_code.cfm?
`id=1728&type=0)
`
`U1781
`(show_code.cfm?
`id=1736&type=0)
`
`U1781
`(show_code.cfm?
`id=1736&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U1781
`(show_code.cfm?
`id=1736&type=0)
`
`DP
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`There is no unexpired exclusivity for this product in the Orange Book database.
`
`View a list of all patent use codes (results_patent.cfm)
`View a list of all exclusivity codes (results_exclusivity.cfm)
`
`http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022511&Appl_type=N
`
`3/3
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