MV.2016
`
`Orarvi Book: ~a.red Dr11<1 Procllc:ts with TherapeuUc &J.llvalence Eveluellans
`
`FDA Home3 Drug DataMZS"' Orange Book5
`Orange Book: Approved Drug, Products with Therapeutic Equivalence Evaluations
`Searc"fi results from the "OB_RX table for query on "02'1038."
`
`DEXMEDETOMIDINE HYDROOiLORIDE
`Active Ingredient:
`Dosage Form;Route:
`INJECTABLE ;INJECTION
`Propr1etary Name:
`PRECEDEX
`HOSPIRA
`Applicant:
`EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
`Strength:
`N021038
`Appllcatlon Number:
`Product Number:
`001
`Dec 17, 1999
`Approval Date:
`Reference Listed Drug
`Yes
`RX
`RX/OTC/DISCN:
`AP
`TE Code:
`Patent and Excluslvlty Info for this product: View
`DEXMEDETOMIDINE HYDROOiLORIDE
`Active Ingredient:
`Dosage Form;Route:
`INJECTABLE ;INJECTION
`Propr1etary Name:
`PRECEDEX
`Applicant:
`HOSPIRA
`Strength:
`EQ 200MCG BASE/SOML (EQ 4MCG BASE/ML)
`Application Number:
`N021038
`Product Number:
`002
`Approval Date:
`Mar 13, 2013
`Reference Listed Drug
`Yes
`RX/orrJ[)ISCN:
`RX
`TE Code:
`Patent and Exclusivity Info for this product: View
`Active Ingredient:
`DEXMEDETOMIDINE HYDROOiLORIDE
`Dosage Form;Route:
`INJECTABLE;INJECTION
`Proprietary Name:
`PRECEDEX
`Appllcant:
`HOSPIRA
`Strength:
`EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
`Application Number:
`N021038
`Product Number:
`003
`Mar 13, 2013
`Approval Date:
`Reference Listed Drug
`Yes
`RX
`RX/orrJDISCN:
`TE Code:
`Patent and Exclusivity Info for this product: View
`Active Ingredient:
`DEXMEDETOMIDINE HYDROOiLORIDE
`Dosage Form;Route:
`INJECTABLE;INJECTION
`Proprietary Name:
`PRECEDEX
`Applicant:
`HOSPIRA
`Strength:
`EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
`Application Number:
`N021038
`Product Number:
`004
`Approval Date:
`Nov 14, 2014
`Reference Listed Drug
`Yes
`RX/orrJDISCN:
`RX
`TE Code:
`
`http:/lwww.aa:.msdam.fda.goY/acrlpstcder/CJbfdoca/cDtatall.cfm?~-No=021038&T.ABLE1=0B_Rx
`
`112
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1036 – Page 1
`
`

`

`
`
`5912016
`
`OrangeBochm'wed Drug Prodtus mm men-spade Explvala‘ce Evalualms
`
`Patent and Exclusivity Info for th is product: \fiew
`
`Return to Electronic Orange Book Home Page6
`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Progiam Support
`Update Frequency:
`Orange Book Data - Monthly
`Generic Drug Product Information & Patent Information - Dally
`Orange Book Data Updated Through June 2016
`Patent and Generic Drug Product Data Last Updated AugLst O9, 2016
`
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`WMWMMWIMM_N MMTABLE1=OB_RX
`
`2I2
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLc - Exhibit 1036 — Page 2
`
`

`

`MV.2016
`
`Orarvi Book: ~a.red Dr11<1 Procllc:ts with TherapeuUc &J.llvalence Eveluellans
`
`FDA Hgme3 POJI Qatebrtr4 O@O!i!e Bogks
`Oranae Book: ~Droved Drua Products with TheraD&utlc Eaulvalence Evaluatlons
`Patent'lnd Exclualvlt;Y Search RMUllll'lrom query on Appl No 021038 Prodlld IXl1 In Iha OB_Rx Hiit.
`
`Patent Data
`
`Appl No r Prod No
`
`N021038
`N021038
`
`001
`001
`
`6716867
`6716867"PED
`
`Exclusivity Data
`
`PatitntNo r
`
`Patent
`Expiration
`Mar31, 2019
`Oct 1, 2019
`
`Drug Sub9tmlc:e
`Clalm
`
`l
`
`l
`
`Drug Product
`Clalm
`
`Patent UH
`Code
`u ·1472
`
`-+
`
`Dellst
`Requeslad
`
`-I
`
`Appl No
`
`Prod No
`
`Exduslvlty Coda
`
`N021038
`ND21038
`
`001
`001
`
`M ·11
`PED
`
`Exclusivity Expiration
`Jun 17, 2016
`D.:17, 2918
`
`- - I
`
`Addllonal lnfonnatlon:
`1. Patents are published upoo receipt by the Orange Book Staff and may not reflect the oflicial receipt date as described in 21 CFR 314.53(d)(5).
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`Patent and Generic Drug Product Data Last Updated Au!JJSt 09, 2016
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`http:/lwww.aa:.msdam..fda.goY/acrlpstcderJobfdoca/peta«new.cfm?Appl_No=021038&Prccb:t_No=001&table1=0B_Rx
`
`1f.l
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1036 – Page 3
`
`

`

`8/9/2016
`
`Orange Book: Apprcwed Drug Proc:Lds with Therapeutic Equivalence Evaluatiais
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/Drugs/lnformationOnDrugs/default.htm
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`5 .. ./default.cfm
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`6 .. ./default. cfm
`
`http://www.accessdata.fda.gov/scripts/cder/ob.'docs/petaxclnew.cfm?Appl_No=021038&Produc:t_No=001&table1=0B_Rx
`
`212
`
`Petition for Inter Partes Review of US 8,338,470
`Amneal Pharmaceuticals LLC – Exhibit 1036 – Page 4
`
`