teduglutide Injection

Brand(s)
Gattex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Nps Pharmaceuticals (2013-01-08)
Oldest Current Product
2012-12-21
License(s)
NDA
RxNORM
INJECTION\TEDUGLUTIDE
FDAOB
SUBCUTANEOUS\POWDER\TEDUGLUTIDE RECOMBINANT
SPL Active
SUBCUTANEOUS\INJECTION, POWDER, FOR SOLUTION\TEDUGLUTIDE
SPL Moiety
SUBCUTANEOUS\INJECTION, POWDER, FOR SOLUTION\TEDUGLUTIDE

product(s) by strength(s)

teduglutide 5 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1688750101GattexNDANps Pharmaceuticals2012-12-21TEDUGLUTIDESUBCUTANEOUSINJECTION, POWDER, FOR SOLUTIONNDA20344166b69c1e-b25c-44d3-b5ff-1c1de9a516fa
2688750103GattexNDANps Pharmaceuticals2012-12-21TEDUGLUTIDE, WATERKITNDA20344166b69c1e-b25c-44d3-b5ff-1c1de9a516fa

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203441GATTEX KITNPS PHARMACEUTICALS INC2012-12-21p7847061, TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
p7056886, TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT, SUBSTANCE
p9060992, TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
p5789379, TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2019-12-21]
NEW CHEMICAL ENTITY [2017-12-21]
NDA203441_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203441_001RXTEDUGLUTIDE RECOMBINANT (5MG/VIAL)SUBCUTANEOUSPOWDERTrue2012-12-21GATTEX KIT

patent(s)

#idexpiration dateapplication(s)
1p5789379 (view patent)2016-04-14NDA203441
2p7056886 (view patent)2022-09-18NDA203441
3p7847061 (view patent)2025-11-01NDA203441
4p9060992 (view patent)2025-11-01NDA203441

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
166b69c1e-b25c-44d3-b5ff-1c1de9a516fa (view SPL)These highlights do not include all the information needed to use GATTEX safely and effectively. See full prescribing information for GATTEX. GATTEX (teduglutide [rDNA origin]), for injection, for subcutaneous use Initial U.S. Approval: 2012prescriptionHuman PrescriptionNps Pharmaceuticals2013-01-083688750101, 688750103, 688750102

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII