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Generated: December 10, 2018

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Details for New Drug Application (NDA): 203505

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NDA 203505 describes OSPHENA, which is a drug marketed by Duchesnay and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the OSPHENA profile page.

The generic ingredient in OSPHENA is ospemifene. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ospemifene profile page.
Summary for 203505
Tradename:OSPHENA
Applicant:Duchesnay
Ingredient:ospemifene
Patents:8
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 203505
Generic Entry Date for 203505*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*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: 203505
Suppliers and Packaging for NDA: 203505
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OSPHENA ospemifene TABLET;ORAL 203505 NDA Shionogi Inc. 59630-580 59630-580-18 1 BLISTER PACK in 1 PACKAGE (59630-580-18) > 15 TABLET, FILM COATED in 1 BLISTER PACK
OSPHENA ospemifene TABLET;ORAL 203505 NDA Shionogi Inc. 59630-580 59630-580-55 1 BLISTER PACK in 1 PACKAGE (59630-580-55) > 5 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Feb 26, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 26, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Jul 21, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
Patent:➤ Sign UpPatent Expiration:Aug 11, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

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