`Case: 1:16-cv—00651 Document #: 47-6 Filed: 11/08/16 Page 1 of 3 PagelD #:2029
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`EXHIBIT 6
`
`EXHIBIT 6
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`
`
`11/8/2016
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Case: 1:16-cv-00651 Document #: 47-6 Filed: 11/08/16 Page 2 of 3 PageID #:2030
`
`Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations
`
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`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: N021038
`
`Product 004
`DEXMEDETOMIDINE HYDROCHLORIDE (PRECEDEX) INJECTABLE EQ 80MCG BASE/20ML
`(EQ 4MCG BASE/ML)
`
`Patent Data
`
`Product
`No
`
`Patent No
`
`Patent
`Expiration
`
`004
`
`6716867
`
`Mar 31,
`2019
`
`Drug
`Substance
`Claim
`
`Drug
`Product
`Claim
`
`Delist
`Requested
`
`Patent Use Code
`
`U1472
`(show_code.cfm?
`id=1480&type=0)
`
`http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=004&Appl_No=021038&Appl_type=N
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`1/2
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`11/8/2016
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`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Case: 1:16-cv-00651 Document #: 47-6 Filed: 11/08/16 Page 3 of 3 PageID #:2031
`
`Product
`No
`
`004
`
`Patent No
`
`Patent
`Expiration
`
`Drug
`Substance
`Claim
`
`Drug
`Product
`Claim
`
`6716867*PED Oct 1,
`2019
`
`004
`
`8242158
`
`Jan 4,
`2032
`
`004
`
`8242158*PED Jul 4, 2032
`
`004
`
`8338470
`
`Jan 4,
`2032
`
`004
`
`8338470*PED Jul 4, 2032
`
`004
`
`8455527
`
`Jan 4,
`2032
`
`004
`
`8455527*PED Jul 4, 2032
`
`004
`
`8648106
`
`Jan 4,
`2032
`
`004
`
`8648106*PED Jul 4, 2032
`
`004
`
`9320712
`
`Jan 4,
`2032
`
`
`
`Exclusivity Data
`
`DP
`
`DP
`
`DP
`
`DP
`
`Delist
`Requested
`
`Patent Use Code
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`U421
`(show_code.cfm?
`id=421&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`(show_code.cfm?
`id=&type=0)
`
`Product No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`There is no unexpired exclusivity for this product in the Orange Book database.
`
`http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=004&Appl_No=021038&Appl_type=N
`
`2/2
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