Generic Osphena Availability
Last updated on Aug 10, 2022.
Osphena is a brand name of ospemifene, approved by the FDA in the following formulation(s):
OSPHENA (ospemifene - tablet;oral)
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Manufacturer: DUCHESNAY
Approval date: February 26, 2013
Strength(s): 60MG [RLD]
Has a generic version of Osphena been approved?
No. There is currently no therapeutically equivalent version of Osphena available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Osphena. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Method for the treatment of vaginal dryness and sexual dysfunction in women during or after the menopause
Patent 6,245,819
Issued: June 12, 2001
Inventor(s): Halonen; Kaija & Kangas; Lauri & DeGregorio; Michael W.
Assignee(s): Hormos Medical Oy, Ltd. Tess Diagnostics and Pharmaceuticals, Inc.This invention concerns a method for the treatment of vaginal dryness or sexual dysfunction in women during or after the menopause, said method comprising administering to the woman an effective amount of the compound (deaminohydroxy)toremifene or a pharmaceutically acceptable salt or ester thereof, or a metabolite thereof.
Patent expiration dates:
- July 21, 2025✓
- July 21, 2025✓
- July 21, 2025
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Method for enhancing the bioavailablity of ospemifene
Patent 8,236,861
Issued: August 7, 2012
Inventor(s): Anttila; Markku
Assignee(s): Hormos Medical CorporationThis invention relates to a method for enhancing the bioavailability of a therapeutically active compound of the formula (I) or a geometric isomer, a stereoisomer, a pharmaceutically acceptable salt, an ester thereof or a metabolite thereof, wherein said compound is administered orally to the individual in connection with the intake of food.
Patent expiration dates:
- August 11, 2026✓
- August 11, 2026✓
- August 11, 2026✓
- August 11, 2026
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Method for enhancing the bioavailability of ospemifene
Patent 8,470,890
Issued: June 25, 2013
Assignee(s): Hormos Medical Ltd.This invention relates to a method for enhancing the bioavailability of a therapeutically active compound of the formula (I) or a geometric isomer, a stereoisomer, a pharmaceutically acceptable salt, an ester thereof or a metabolite thereof, wherein said compound is administered orally to the individual in connection with the intake of food.
Patent expiration dates:
- February 13, 2024✓
- February 13, 2024✓
- February 13, 2024✓
- February 13, 2024
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Solid formulations of ospemifene
Patent 8,642,079
Issued: February 4, 2014
Assignee(s): Hormos Medical CorporationThis invention relates to a solid drug formulation comprising granulates containing a therapeutically active compound of the formula (I) or a geometric isomer, a stereoisomer, a pharmaceutically acceptable salt, an ester thereof or a metabolite thereof, in combination with one or more intra-granular excipients.
Patent expiration dates:
- July 9, 2028✓
- July 9, 2028
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Method for enhancing the bioavalability of ospemifene
Patent 8,772,353
Issued: July 8, 2014
Assignee(s): Hormos Medical Ltd.This invention relates to a method for enhancing the bioavailability of a therapeutically active compound of the formula (I) or a geometric isomer, a stereoisomer, a pharmaceutically acceptable salt, an ester thereof or a metabolite thereof, wherein said compound is administered orally to the individual in connection with the intake of food.
Patent expiration dates:
- February 13, 2024✓
- February 13, 2024✓
- February 13, 2024✓
- February 13, 2024
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Method for enhancing the bioavailability of ospemifene
Patent 9,241,915
Issued: January 26, 2016
Assignee(s): QuatRx PharmaceuticalsThis invention relates to a method for enhancing the bioavailability of a therapeutically active compound of the formula (I) or a geometric isomer, a stereoisomer, a pharmaceutically acceptable salt, an ester thereof or a metabolite thereof, wherein said compound is administered orally to the individual in connection with the intake of food.
Patent expiration dates:
- February 13, 2024✓
- February 13, 2024✓
- February 13, 2024✓
- February 13, 2024
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Method for the alleviation of dyspareunia in women
Patent 9,566,252
Issued: February 14, 2017
Assignee(s): HORMOS MEDICAL LTD.This invention relates to a method for inhibition of skin atrophy, or epithelial or mucosal atrophy in women, or to a method for treatment or prevention of symptoms related to said atrophy, said method comprising administering to the woman an effective amount of the compound of formula (I) or a geometric isomer, a stereoisomer, a pharmaceutically acceptable salt, an ester thereof or a metabolite thereof.
Patent expiration dates:
- November 2, 2022✓
- November 2, 2022
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Method for enhancing the bioavailability of ospemifene
Patent 9,855,224
Issued: January 2, 2018
Assignee(s): HORMOS MEDICAL CORPORATIONThis invention relates to a method for enhancing the bioavailability of a therapeutically active compound of the formula (I) or a geometric isomer, a stereoisomer, a pharmaceutically acceptable salt, an ester thereof or a metabolite thereof, wherein said compound is administered orally to the individual in connection with the intake of food.
Patent expiration dates:
- February 13, 2024✓
- February 13, 2024✓
- February 13, 2024✓
- February 13, 2024
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- January 25, 2022 - TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS, A SYMPTOM OF VULVAR AND VAGINAL ATROPHY, DUE TO MENOPAUSE
More about Osphena (ospemifene)
- Side effects
- Drug interactions
- Dosage information
- During pregnancy
- Reviews (44)
- Drug images
- Pricing & coupons
- En español
- Drug class: selective estrogen receptor modulators
- FDA approval history
Patient resources
Professional resources
Related treatment guides
Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.