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Last Updated: May 23, 2024

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 two suppliers. There are seven patents protecting this drug. Additional details are available on the OSPHENA profile page.

The generic ingredient in OSPHENA is ospemifene. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ospemifene profile page.
Summary for 203505
Tradename:OSPHENA
Applicant:Duchesnay
Ingredient:ospemifene
Patents:7
Formulation / Manufacturing:see details
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 Duchesnay USA, Inc. 55494-580 55494-580-18 1 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK
OSPHENA ospemifene TABLET;ORAL 203505 NDA Duchesnay USA, Inc. 55494-580 55494-580-30 30 TABLET, FILM COATED in 1 BOTTLE (55494-580-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Feb 26, 2013TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jul 21, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
Patent:⤷  Sign UpPatent Expiration:Jul 21, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
Patent:⤷  Sign UpPatent Expiration:Aug 11, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE

Expired US Patents for NDA 203505

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Sign Up ⤷  Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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