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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
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Teva
Fish and Richardson
Farmers Insurance
Federal Trade Commission
US Department of Justice
McKesson
AstraZeneca

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203441

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NDA 203441 describes GATTEX KIT, which is a drug marketed by Nps Pharms Inc and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GATTEX KIT profile page.

The generic ingredient in GATTEX KIT is teduglutide recombinant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the teduglutide recombinant profile page.
Summary for 203441
Tradename:GATTEX KIT
Applicant:Nps Pharms Inc
Ingredient:teduglutide recombinant
Patents:11
Formulation / Manufacturing:see details
Pharmacology for NDA: 203441
Suppliers and Packaging for NDA: 203441
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441 NDA Shire-NPS Pharmaceuticals, Inc. 68875-0101 N 68875-0101-2
GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441 NDA Shire-NPS Pharmaceuticals, Inc. 68875-0102 N 68875-0102-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrength5MG/VIAL
Approval Date:Dec 21, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 21, 2019
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT
Patent:➤ Try a Free TrialPatent Expiration:Apr 14, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
Patent:➤ Try a Free TrialPatent Expiration:Sep 18, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Citi
Dow
Cipla
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Colorcon
AstraZeneca
Covington
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