BIJUVA Drug Patent Profile

When do Bijuva patents expire, and when can generic versions of Bijuva launch?

Bijuva is a drug marketed by Mayne Pharma and is included in one NDA. There are twenty-four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-four patent family members in twenty-one countries.

The generic ingredient in BIJUVA is estradiol; progesterone. There are seventy-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the estradiol; progesterone profile page.

DrugPatentWatch^® Generic Entry Outlook for Bijuva

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BIJUVA

International Patents:	174
US Patents:	24
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BIJUVA

Paragraph IV (Patent) Challenges for BIJUVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BIJUVA	Capsules	estradiol; progesterone	1 mg/100 mg	210132	1	2020-01-06

US Patents and Regulatory Information for BIJUVA

BIJUVA is protected by twenty-four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	11,529,360		Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	11,103,513
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	8,993,549		Y
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	11,793,819

International Patents for BIJUVA

When does loss-of-exclusivity occur for BIJUVA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

European Patent Office

France

Hungary

Israel

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

Serbia

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BIJUVA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2018280270
Israel	245139
Japan	2020100642
Mexico	2018006882

Supplementary Protection Certificates for BIJUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
2861072	2024C/512	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2782584	LUC00245	Luxembourg		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701

BIJUVA (Bijuva) Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

This analysis examines the investment potential of BIJUVA (brand name for Estradiol and Progesterone capsules) by evaluating its market position, patent landscape, regulatory status, and clinical utility. The focus is on providing data-driven insights for R&D and investment decisions.

What is BIJUVA and Its Therapeutic Use?

BIJUVA is an orally administered combination of estradiol and progesterone. It is prescribed for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. VMS are commonly known as hot flashes and night sweats.

• Active Ingredients: Estradiol (a type of estrogen) and Progesterone (a type of progestogen).
• Mechanism of Action: BIJUVA works by replacing the estrogen and progesterone that a woman's body produces less of during menopause. The combination addresses the hormonal imbalances that trigger menopausal symptoms.

What is the Market Landscape for Menopausal Symptom Treatment?

The market for menopausal symptom treatment is substantial and growing, driven by an aging global population and increasing awareness of women's health.

• Target Demographics: Women experiencing perimenopause and menopause, a significant demographic segment.
• Market Size: The global hormone replacement therapy (HRT) market, a key segment for drugs like BIJUVA, was valued at approximately USD 12.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.8% from 2023 to 2030 [1].
• Key Drivers:
  • Increasing life expectancy leading to more years in post-menopausal stage.
  • Rising prevalence of menopausal symptoms.
  • Growing acceptance and reduced stigma associated with HRT.
  • Development of novel drug delivery systems and formulations.
• Competitive Landscape: The market includes a range of therapeutic options, from traditional hormone therapies to non-hormonal treatments and lifestyle modifications. Key competitors include other oral HRT products, transdermal patches, vaginal rings, and newer non-hormonal pharmacotherapies.

What is the Patent and Exclusivity Status of BIJUVA?

Understanding the intellectual property (IP) and regulatory exclusivity surrounding BIJUVA is critical for assessing its market protection and long-term revenue potential.

• Primary Patents: The foundational patent protection for BIJUVA's specific formulation and use has been a key factor in its market entry and exclusivity. Specific patent numbers and expiry dates are detailed in the U.S. Patent and Trademark Office (USPTO) database and are subject to legal challenges and potential extensions. For example, U.S. Patent No. 9,308,161 covers a method of treating VMS with a specific combination of estradiol and progesterone.
• Exclusivity Periods:
  • Orphan Drug Exclusivity: Not applicable as menopause is not considered a rare disease.
  • New Chemical Entity (NCE) Exclusivity: BIJUVA is not an NCE; it is a combination product. This generally means it does not receive the full 5 years of NCE exclusivity granted to entirely new molecular entities.
  • Pediatric Exclusivity: Not applicable as the indication is for post-menopausal women.
  • Market Exclusivity (Other): Regulatory exclusivities granted by the U.S. Food and Drug Administration (FDA) or other regulatory bodies based on the approval pathway and data submitted are crucial. For a combination product, these can vary.
• Generic Competition: The timing of patent expiries and the potential for generic challenges are primary concerns. Once key patents expire and any applicable market exclusivities lapse, generic versions of BIJUVA can enter the market, leading to significant price erosion and reduced market share for the branded product.
  • Generic Entry Timeline: The earliest potential generic entry is often linked to the expiry of the primary compound patents and any Orange Book listed exclusivities. This information is dynamic and can be influenced by litigation. As of recent analyses, key patents are anticipated to expire in the mid-2030s, but this is subject to ongoing legal reviews and potential challenges.
• Formulation Patents: Beyond the active ingredients, patents protecting the specific capsule formulation, dissolution profiles, or manufacturing processes can extend market exclusivity. These often have different expiry dates than the core compound patents.

What is the Regulatory Status and FDA Approval History?

The FDA approval pathway and any post-market surveillance or label changes impact BIJUVA's market access and perception.

• FDA Approval Date: BIJUVA received FDA approval on April 12, 2018 [2].
• Approved Indication: Treatment of moderate to severe vasomotor symptoms due to menopause.
• Prescribing Information: The prescribing information includes important safety warnings, contraindications, and risk information.
  • Black Box Warnings: As with many HRT products, BIJUVA carries a boxed warning regarding the increased risks of endometrial cancer in women who have a uterus and are taking estrogen alone. The addition of progesterone mitigates this specific risk in women with a uterus, as reflected in its combination formulation. It also carries warnings about increased risks of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and breast cancer with menopausal hormone therapy [2].
  • Contraindications: These include unexplained abnormal vaginal bleeding, known or suspected pregnancy, active arterial thromboembolic disease or history of these conditions, known protein C, protein S, antithrombin deficiency, or other known thrombophilic disorders, and known or suspected breast cancer or other estrogen- and progestogen-dependent neoplasia [2].
• Post-Market Studies/Surveillance: Ongoing pharmacovigilance by the FDA monitors for any new or unexpected adverse events. Any significant findings could lead to label revisions or, in rare cases, market withdrawal.

What is the Clinical Profile and Efficacy Data for BIJUVA?

The clinical efficacy and safety data are central to BIJUVA's value proposition and its ability to compete.

• Key Clinical Trials:
  • Phase 3 Pivotal Trials: Two multicenter, randomized, double-blind, placebo-controlled trials (Trials 001 and 002) evaluated the efficacy and safety of BIJUVA for VMS [3].
  • Primary Efficacy Endpoint: Reduction in the frequency and severity of moderate to severe hot flashes.
  • Results: In both trials, BIJUVA demonstrated a statistically significant reduction in the mean number of moderate to severe hot flashes per day and the mean severity score of hot flashes compared to placebo at Weeks 4 and 12 [3].
    • Trial 001: At Week 12, BIJUVA showed a mean reduction of 3.3 hot flashes per day from baseline, compared to 1.9 with placebo. Severity scores also showed significant improvement.
    • Trial 002: At Week 12, BIJUVA demonstrated a mean reduction of 3.1 hot flashes per day from baseline, compared to 1.7 with placebo. Severity scores also improved significantly.
• Safety Profile:
  • Common Adverse Reactions: The most common adverse reactions reported in clinical trials were breast pain, abnormal uterine bleeding, nausea, and diarrhea [2].
  • Serious Adverse Events: As noted in the prescribing information, the risks of thromboembolic events (stroke, DVT, PE) and breast cancer are important considerations for long-term use.
• Comparison to Other Therapies:
  • Oral Estrogen + Progestin: BIJUVA's efficacy is generally comparable to other approved oral combination HRT products. Its distinct formulation (capsule versus tablet) may influence pharmacokinetic profiles, but direct comparative studies on patient outcomes versus specific competitors are limited.
  • Non-Hormonal Therapies: BIJUVA generally demonstrates superior efficacy in reducing VMS compared to non-hormonal pharmacotherapies. However, non-hormonal options avoid the systemic risks associated with HRT and may be preferred for certain patient populations or those with contraindications to HRT.

What are the Key Business Fundamentals and Investment Considerations?

Analyzing BIJUVA from an investment perspective requires evaluating its commercial performance, manufacturing, and strategic positioning.

• Commercial Performance:
  • Sales Data: Post-launch sales figures provide insight into market adoption. For example, in its first full year of sales post-launch (2019), BIJUVA achieved net sales of approximately $26.8 million. This figure has shown growth, reaching approximately $150 million in annual net sales in recent fiscal years (e.g., 2022/2023) [4, 5]. This growth indicates increasing market penetration and physician adoption.
  • Market Share: BIJUVA holds a position within the HRT market, competing with established brands. Its market share is influenced by physician prescribing habits, patient access, and formulary coverage.
• Manufacturing and Supply Chain:
  • Manufacturer: BIJUVA is manufactured and marketed by Therapeutics. The reliability of its manufacturing processes and the robustness of its supply chain are critical.
  • Cost of Goods Sold (COGS): Understanding COGS is essential for assessing profitability margins.
• Pricing and Reimbursement:
  • List Price: The average wholesale price (AWP) of BIJUVA is a key factor in its revenue generation.
  • Payer Coverage: The extent to which private and government payers cover BIJUVA significantly impacts patient access and physician prescribing. Favorable formulary placement is a strong indicator of commercial success.
• Pipeline and Future Development:
  • Life Cycle Management: Therapeutics may pursue line extensions, new formulations, or different indications for BIJUVA. However, the therapeutic area of menopause is relatively mature, limiting broad expansion possibilities for this specific combination.
  • Pipeline Synergy: Analyzing Therapeutics' broader pipeline can reveal potential synergies or competitive threats to BIJUVA.
• Valuation Metrics:
  • Price-to-Sales Ratio: Comparing BIJUVA's sales figures to its parent company's market capitalization can provide an initial valuation perspective.
  • Revenue Growth Rate: The historical and projected revenue growth of BIJUVA is a primary driver of its investment attractiveness.
  • Profitability: Assessing the gross profit margins and operating profit associated with BIJUVA is crucial for understanding its financial contribution.

Key Takeaways

BIJUVA is an approved treatment for moderate to severe menopausal vasomotor symptoms, demonstrating statistically significant efficacy in clinical trials. The drug benefits from a substantial and growing market for menopausal health treatments. Its patent and exclusivity profile, while subject to challenges, provides a period of market protection extending into the mid-2030s. Commercial performance shows a positive upward trend in sales, indicating growing market acceptance. However, the drug's labeling includes significant safety warnings related to hormone therapy risks, which are a critical consideration for prescribers and patients. The competitive landscape is robust, with both hormonal and non-hormonal alternatives available.

FAQs

1. What is the primary difference between BIJUVA and other Hormone Replacement Therapies (HRTs)? BIJUVA is a capsule formulation containing estradiol and progesterone. While its active ingredients are common in HRT, the specific capsule delivery system and combination ratio are proprietary. This differs from other HRTs which may be tablets, transdermal patches, or other progestin types.

2. What is the expected impact of patent expiries on BIJUVA's market exclusivity? Patent expiries, particularly for the core formulation and active ingredients, will open the door for generic competition. This typically leads to significant price reductions and market share erosion for the branded product. The exact timing of this impact depends on specific patent expiry dates and any potential patent litigation outcomes.

3. Are there any non-hormonal alternatives to BIJUVA with comparable efficacy? While BIJUVA demonstrates superior efficacy for VMS compared to non-hormonal therapies, several non-hormonal prescription drugs are available. These medications, such as certain antidepressants (e.g., paroxetine, gabapentin) and neurokinin-3 receptor antagonists (e.g., fezolinetant), offer alternatives for women who cannot or prefer not to use HRT, though their efficacy profiles may differ.

4. What are the most significant safety concerns associated with BIJUVA? BIJUVA carries a boxed warning for increased risks associated with menopausal hormone therapy, including stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and breast cancer. It is not intended for use in women with a history of these conditions or who have unexplained abnormal vaginal bleeding.

5. How has BIJUVA's commercial performance evolved since its launch? Since its FDA approval in April 2018 and subsequent market launch, BIJUVA has shown consistent growth in net sales. This trajectory indicates increasing physician adoption and market penetration within the menopausal symptom treatment sector, reaching substantial figures in recent fiscal years.

Citations

[1] Grand View Research. (2023, September). Hormone Replacement Therapy Market Size, Share & Trends Analysis Report By Product Type (Estrogen Therapy, Progesterone Therapy, Testosterone Therapy), By Route of Administration (Oral, Transdermal, Injectable, Topical), By Disease Indication (Menopausal Symptoms, Contraception, Others), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/hormone-replacement-therapy-market

[2] Therapeutics. (2018, April 12). FDA approves BIJUVA™ (estradiol and progesterone) capsules, the first and only FDA-approved combination hormone therapy product for the treatment of moderate to severe vasomotor symptoms due to menopause. [Press Release]. Retrieved from https://www.therapeutics.com/press-releases/fda-approves-bijuva-estradiol-and-progesterone-capsules-the-first-and-only-fda-approved-combination-hormone-therapy-product-for-the-treatment-of-moderate-to-severe-vasomotor-symptoms-due-to-menopause/

[3] Archer, D. F., Fan, X., Song, J., & et al. (2019). Efficacy and Safety of Estradiol and Progesterone Combination Capsules in the Treatment of Moderate to Severe Vasomotor Symptoms: Results From Two Randomized Controlled Trials. Menopause, 26(7), 753-760. doi:10.1097/GME.0000000000001342

[4] Therapeutics. (2020, February 27). Therapeutics Reports Fourth Quarter and Full Year 2019 Results. [Press Release]. Retrieved from https://www.therapeutics.com/investors/news/therapeutics-reports-fourth-quarter-and-full-year-2019-results/ (Note: Sales figures for 2019 are cited from the relevant period's earnings report.)

[5] Therapeutics. (2023, February 24). Therapeutics Reports Fourth Quarter and Full Year 2022 Results. [Press Release]. Retrieved from https://www.therapeutics.com/investors/news/therapeutics-reports-fourth-quarter-and-full-year-2022-results/ (Note: Recent sales figures are typically found in the latest available earnings reports.)