Ospemifene Oral Tablet

Brand(s)
Osphena
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Shionogi Inc. (2015-08-05)
Oldest Current Product
2013-02-26
License(s)
NDA
RxNORM
ORAL TABLET\OSPEMIFENE
FDAOB
ORAL\TABLET\OSPEMIFENE
SPL Active
ORAL\TABLET, FILM COATED\OSPEMIFENE
SPL Moiety
ORAL\TABLET, FILM COATED\OSPEMIFENE

product(s) by strength(s)

ospemifene 60 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596300580OsphenaNDAShionogi Inc.2013-02-26OSPEMIFENEORALTABLET, FILM COATEDNDA2035058462d6ab-e3cd-4efa-a360-75bf8f917287

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203505OSPHENASHIONOGI INC2013-02-26p8470890, TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE/ TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE
p8236861, TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE/ TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE
p8642079, SUBSTANCE
p6245819, TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE
p8772353, TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE/ TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE
NEW CHEMICAL ENTITY [2018-02-26]NDA203505_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203505_001RXOSPEMIFENE (60MG)ORALTABLETTrue2013-02-26OSPHENA

patent(s)

#idexpiration dateapplication(s)
1p6245819 (view patent)2020-07-21NDA203505
2p8236861 (view patent)2026-08-11NDA203505
3p8470890 (view patent)2024-02-13NDA203505
4p8642079 (view patent)2028-07-09NDA203505
5p8772353 (view patent)2024-02-13NDA203505

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
18462d6ab-e3cd-4efa-a360-75bf8f917287 (view SPL)These highlights do not include all the information needed to use OSPHENA safely and effectively. See full prescribing information for OSPHENA. OSPHENA (ospemifene) tablets, for oral use Initial U.S. Approval: 2013prescriptionHuman PrescriptionShionogi Inc.MANUFACTURE, PACK2015-08-0516596300580

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