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 two 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. One supplier is listed for this compound. Additional details are available on the ospemifene profile page.
The generic ingredient in OSPHENA is ospemifene. There are six 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: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
| Mechanism of Action | Selective Estrogen Receptor Modulators |
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: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Feb 26, 2013 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 11, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 11, 2026 | Product 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: | ⤷ Start Trial | Patent Expiration: | Aug 11, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE | ||||||||
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 | ⤷ Start Trial | ⤷ Start Trial |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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