Generic Bijuva Availability
Last updated on Jan 11, 2023.
Bijuva is a brand name of estradiol/progesterone, approved by the FDA in the following formulation(s):
BIJUVA (estradiol; progesterone - capsule;oral)
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Manufacturer: MAYNE PHARMA
Approval date: October 28, 2018
Strength(s): 1MG;100MG [RLD] -
Manufacturer: MAYNE PHARMA
Approval date: December 28, 2021
Strength(s): 0.5MG;100MG (discontinued) [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.
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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✓
- November 21, 2032
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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✓
- November 21, 2032
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Patent 10,639,375
Patent expiration dates:
- November 21, 2032✓
- November 21, 2032
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Patent 10,675,288
Patent expiration dates:
- November 21, 2032✓
- November 21, 2032
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Patent 10,806,740
Patent expiration dates:
- November 21, 2032✓✓
- November 21, 2032
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Patent 11,033,626
Patent expiration dates:
- November 21, 2032✓✓
- November 21, 2032
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Patent 11,103,513
Patent expiration dates:
- November 21, 2032✓
- November 21, 2032
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Patent 11,103,516
Patent expiration dates:
- November 21, 2032✓
- November 21, 2032
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Patent 11,110,099
Patent expiration dates:
- November 21, 2032✓
- November 21, 2032
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Patent 11,166,963
Patent expiration dates:
- November 21, 2032✓
- November 21, 2032
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Patent 11,529,360
Patent expiration dates:
- November 21, 2032✓
- November 21, 2032
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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✓
- November 21, 2032
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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✓
- November 21, 2032
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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✓✓
- November 21, 2032
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Natural combination hormone replacement formulations and therapies
Patent 8,933,059
Issued: January 13, 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✓✓
- November 21, 2032
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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✓
- November 21, 2032
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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✓
- November 21, 2032
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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✓
- November 21, 2032
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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✓✓
- November 21, 2032
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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✓
- November 21, 2032
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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✓✓
- November 21, 2032
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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✓✓
- November 21, 2032
More about Bijuva (estradiol / progesterone)
- Check interactions
- Pricing & coupons
- Reviews (34)
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: sex hormone combinations
- En español
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.