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`S'"earch results from the "OB_Rx" table for query on "203441."
`
`Active Ingredient:
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`Product Number:
`Approval Date:
`Reference Listed Drug
`RX/OTC/DISCN:
`TE Code:
`Patent and Exclusivity Info for this product: View
`
`TEDUGLUTIDE RECOMBINANT
`POWDER; SU BC UTAN EOUS
`GATTEX KIT
`NPS PHARMS INC
`SMG/VIAL
`N203441
`001
`Dec 21, 2012
`Yes
`RX
`
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`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
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`http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm9 Appl_ No=20344 l &TABLE l =OB_ Rx
`
`1
`
`CFAD Exhibit 1076
`CFAD v. NPS
`IPR2015-00990
`
`
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
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`FDA Home' Dru~ Databases' Oran~e Book5
`Ora nae Book:.Aaaroveri Drug Products with Theraaeutic Eauivalence Fvaluations
`Fl"atenrancfExclus1v;ty~earcfl~esults from query on Appl No 203441 Producroo11n the OB~x fist.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`Patent
`Expiration
`
`' Drug Substance
`·
`Claim
`
`'
`
`Drug Product
`Claim
`
`N203441
`
`N203441
`
`N203441
`
`N203441
`
`001
`
`001
`
`001
`
`' 001
`
`Exclusivity Data
`
`5789379
`
`7056886
`
`7847061
`
`'. 9060992
`
`y
`
`Apr14,2020
`
`Sep 18, 2022
`
`Nov 1, 2025
`
`Nov 1, 2025
`
`y
`
`y
`
`_r
`
`Delist
`Requested
`
`Patent Use
`Code
`u -1320
`: u -1320
`i u -1320
`: u -1320
`
`Appl No
`
`Prod No
`
`Exclusivity Code
`
`Exclusivity Expiration
`
`N203441
`
`N203441
`
`001
`
`001
`
`NCE
`
`ODE
`
`Dec 21, 2017
`
`Dec 21, 2019
`
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`respect to other claims which may apply.
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`View a list of all patent use codes
`View a list of all exclusivity codes
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`FDA/Genier for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
`Update Frequency:
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`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through March 2016
`Patent and Generic Drug Product Data Last Updated April 15, 2016
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`U.S. Food and Drug Administration
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`Contacl FDA
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`l'~.\.~ , ~ CJ Ii ·.• . 1.eo.
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`For Government For Press
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`3