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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)

  • 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.

  • 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
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
    • July 21, 2025
      ✓ 
      Patent use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
  • Method for enhancing the bioavailablity of ospemifene
    Patent 8,236,861
    Issued: August 7, 2012
    Inventor(s): Anttila; Markku
    Assignee(s): Hormos Medical Corporation

    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:

    • August 11, 2026
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
    • August 11, 2026
      ✓ 
      Patent use: TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE
    • August 11, 2026
      ✓ 
      Patent use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
  • 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
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
    • February 13, 2024
      ✓ 
      Patent use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
    • February 13, 2024
      ✓ 
      Patent use: TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE
  • Solid formulations of ospemifene
    Patent 8,642,079
    Issued: February 4, 2014
    Assignee(s): Hormos Medical Corporation

    This 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
      ✓ 
      Drug product
  • 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
      ✓ 
      Patent use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
    • February 13, 2024
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
    • February 13, 2024
      ✓ 
      Patent use: TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE
  • Method for enhancing the bioavailability of ospemifene
    Patent 9,241,915
    Issued: January 26, 2016
    Assignee(s): QuatRx Pharmaceuticals

    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
      ✓ 
      Patent use: TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE
    • February 13, 2024
      ✓ 
      Patent use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
    • February 13, 2024
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
  • 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
      ✓ 
      Patent use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
  • Method for enhancing the bioavailability of ospemifene
    Patent 9,855,224
    Issued: January 2, 2018
    Assignee(s): HORMOS MEDICAL CORPORATION

    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
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
    • February 13, 2024
      ✓ 
      Patent use: TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
    • February 13, 2024
      ✓ 
      Patent use: TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE

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

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.

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