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Generic Bijuva Availability

Last updated on Oct 6, 2021.

Bijuva is a brand name of estradiol/progesterone, approved by the FDA in the following formulation(s):

BIJUVA (estradiol; progesterone - capsule;oral)

  • Manufacturer: THERAPEUTICSMD INC
    Approval date: October 28, 2018
    Strength(s): 1MG;100MG [RLD]

Has a generic version of Bijuva been approved?

No. There is currently no therapeutically equivalent version of Bijuva available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Bijuva. 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.

  • Progesterone formulations
    Patent 10,052,386
    Issued: August 21, 2018
    Assignee(s): TherapeuticsMD, Inc.

    Various pharmaceutical formulations are disclosed herein. For example, a pharmaceutical formulation is disclosed comprising ultra-micronized progesterone.

    Patent expiration dates:

    • November 21, 2032
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      Drug product
  • Natural combination hormone replacement formulations and therapies
    Patent 10,206,932
    Issued: February 19, 2019
    Assignee(s): TherapeuticsMD, Inc.

    Pharmaceutical compositions for co-administering estradiol and progesterone to a human subject in need thereof are provided. In some embodiments, the pharmaceutical composition comprises solubilized estradiol, suspended progesterone, and a solubilizing agent comprising a medium chain (C6-C12) oil.

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Patent use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
  • Patent 10,639,375

    Patent expiration dates:

    • November 21, 2032
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      Drug product
  • Patent 10,675,288

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Patent use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
  • Patent 10,806,740

    Patent expiration dates:

    • November 21, 2032
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      Patent use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
      ✓ 
      Drug product
  • Patent 11,033,626

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Patent use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
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      Drug product
  • Patent 11,103,513

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Patent use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
  • Patent 11,103,516

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Drug product
  • Patent 11,110,099

    Patent expiration dates:

    • November 21, 2032
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      Drug product
  • Natural combination hormone replacement formulations and therapies
    Patent 8,633,178
    Issued: January 21, 2014
    Assignee(s): TherapeuticsMD, Inc.

    Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Drug product
  • Natural combination hormone replacement formulations and therapies
    Patent 8,846,648
    Issued: September 30, 2014
    Assignee(s): TherapeuticsMD, Inc.

    Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Patent use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
  • Natural combination hormone replacement formulations and therapies
    Patent 8,846,649
    Issued: September 30, 2014
    Assignee(s): TherapeuticsMD, Inc.

    Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

    Patent expiration dates:

    • November 21, 2032
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      Patent use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
      ✓ 
      Drug product
  • Natural combination hormone replacement formulations and therapies
    Patent 8,987,237
    Issued: March 24, 2015
    Assignee(s): TherapeuticsMD, Inc.

    Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Drug product
  • Natural combination hormone replacement formulations and therapies
    Patent 8,993,548
    Issued: March 31, 2015
    Assignee(s): TherapeuticsMD, Inc.

    Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Drug product
  • Natural combination hormone replacement formulations and therapies
    Patent 8,993,549
    Issued: March 31, 2015
    Assignee(s): TherapeuticsMD, Inc.

    Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Drug product
  • Natural combination hormone replacement formulations and therapies
    Patent 9,006,222
    Issued: April 14, 2015
    Assignee(s): TherapeuticsMD, Inc.

    Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Patent use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
      ✓ 
      Drug product
  • Natural combination hormone replacement formulations and therapies
    Patent 9,114,145
    Issued: August 25, 2015
    Assignee(s): TherapeuticsMD, Inc.

    Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Patent use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
  • Natural combination hormone replacement formulations and therapies
    Patent 9,114,146
    Issued: August 25, 2015
    Assignee(s): TherapeuticsMD, Inc.

    Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Patent use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
      ✓ 
      Drug product
  • Natural combination hormone replacement formulations and therapies
    Patent 9,301,920
    Issued: April 5, 2016
    Assignee(s): TherapeuticsMD, Inc.

    Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Patent use: TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
      ✓ 
      Drug product

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:

    • October 28, 2021 - NEW PRODUCT

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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