Generic Osphena Availability
Last updated on Jun 11, 2025.
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]
Is there a generic version of Osphena available?
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 et al.
Assignee(s): Hormos Medical Oy, Ltd. (N/A, FI); Tess Diagnostics and Pharmaceuticals, Inc. (Granite Bay, CA)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)
Patent expiration dates:
- August 11, 2026✓
- August 11, 2026✓
- August 11, 2026✓
- August 11, 2026
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Solid formulations of ospemifene
Patent 8,642,079
Issued: February 4, 2014
Inventor(s): Lehtola Veli-Matti & Halonen Kaija
Assignee(s): Hormos Medical CorporationThis invention relates to a solid drug formulation comprising granulates containing a therapeutically active compound of the formula (I)
Patent expiration dates:
- July 9, 2028✓
- July 9, 2028
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- Drug class: selective estrogen receptor modulators
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Glossary
| Term | Definition |
|---|---|
| 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.
