Teriparatide Pen Injector

Brand(s)
Forteo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eli Lilly And Company (2015-02-10)
Oldest Current Product
2008-10-01
License(s)
NDA
RxNORM
PEN INJECTOR\TERIPARATIDE
FDAOB
SUBCUTANEOUS\INJECTION\TERIPARATIDE RECOMBINANT HUMAN
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\TERIPARATIDE
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\TERIPARATIDE

product(s) by strength(s)

28 actuat teriparatide 0.02 mg/actuat pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000028400ForteoNDAEli Lilly And Company2008-10-01TERIPARATIDESUBCUTANEOUSINJECTION, SOLUTIONNDA021318aae667c5-381f-4f92-93df-2ed6158d07b0

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021318FORTEOELI LILLY AND CO2002-11-26p7550434, A METHOD OF TREATING OSTEOPOROSIS, SUBSTANCE
p6770623, A METHOD OF TREATING OSTEOPOROSIS/ FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE AT HIGH RISK FOR FRACTURE, SUBSTANCE
p7144861, SUBSTANCE
p7351414, METHOD OF TREATMENT OF OSTEOPOROSIS WHEREIN THE OSTEOPOROSIS IS STEROID-INDUCED/ METHOD FOR THE TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND AT RISK FOR BONE FRACTURE/ TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND A HIGH RISK FOR BONE FRACTURE BY REDUCING THE RISK OF VERTEBRAL AND NONVERTEBRAL BONE FRACTURE
p7517334, SUBSTANCE
p6977077, A METHOD OF TREATING OSTEOPOROSIS/ METHOD OF TREATMENT OF OSTEOPOROSIS WHEREIN THE OSTEOPOROSIS IS STEROID-INDUCED/ FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE AT HIGH RISK FOR FRACTURE
p7163684, METHOD OF TREATING OSTEOPOROSIS IN A POST-MENOPAUSAL WOMAN AT RISK FOR FRACTURE/ METHOD OF TREATMENT OF OSTEOPOROSIS WHEREIN THE OSTEOPOROSIS IS STEROID-INDUCED/ FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS WHO ARE AT RISK FOR FRACTURE. FORTEO CAN BE USED BY PEOPLE WHO HAVE HAD A FRACTURE RELATED TO OSTEOPOROSIS
NDA021318_001, NDA021318_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021318_001discontinuedTERIPARATIDE RECOMBINANT HUMAN (0.75MG/3ML)SUBCUTANEOUSINJECTIONFalse2002-11-26FORTEO
2NDA021318_002RXTERIPARATIDE RECOMBINANT HUMAN (0.6MG/2.4ML)SUBCUTANEOUSINJECTIONTrue2008-06-25FORTEO

patent(s)

#idexpiration dateapplication(s)
1p6770623 (view patent)2018-12-08NDA021318
2p6977077 (view patent)2019-08-19NDA021318
3p7144861 (view patent)2018-12-08NDA021318
4p7163684 (view patent)2019-08-19NDA021318
5p7351414 (view patent)2019-08-19NDA021318
6p7517334 (view patent)2025-03-25NDA021318
7p7550434 (view patent)2018-12-08NDA021318

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1aae667c5-381f-4f92-93df-2ed6158d07b0 (view SPL)These highlights do not include all the information needed to use FORTEO safely and effectively. See full prescribing information for FORTEO.FORTEO (teriparatide [rDNA origin] injection) for subcutaneous useInitial U.S. Approval: 2002prescriptionHuman PrescriptionEli Lilly And Company2015-02-1023000028400

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