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Last Updated: July 7, 2020

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 twenty-one 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:21
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 203441
Generic Entry Date for 203441*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT
Dosage:
POWDER;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 68875-0101-2 30 VIAL in 1 CARTON (68875-0101-2) > .5 mL in 1 VIAL (68875-0101-1)
GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441 NDA Shire-NPS Pharmaceuticals, Inc. 68875-0102 68875-0102-1 1 KIT in 1 CARTON (68875-0102-1) * .5 mL in 1 SYRINGE, PLASTIC * .7 mL in 1 PACKET * .5 mL in 1 VIAL (68875-0101-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrength5MG/VIAL
Approval Date:Dec 21, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 21, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:May 16, 2026
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT
Patent:  Start TrialPatent Expiration:Oct 14, 2020Product Flag?Substance Flag?Delist Request?Y

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