Bijuva Shortage: What Providers and Prescribers Need to Know in 2026

Provider Briefing: Bijuva Availability in 2026

Bijuva (Estradiol and Progesterone capsules) occupies a unique position in the menopause hormone therapy landscape as the only FDA-approved combination of bioidentical estradiol and bioidentical progesterone. While patient interest in this product continues to grow, providers should be aware of the ongoing availability challenges that can complicate prescribing and patient adherence.

This briefing covers the current supply picture, prescribing implications, cost and access considerations, and clinical tools to help your patients get the medication they need.

Timeline: How We Got Here

Understanding the supply history provides context for current challenges:

• October 2018: FDA approves Bijuva (NDA 210132), marketed by TherapeuticsMD
• December 2022: TherapeuticsMD licenses Bijuva (along with Imvexxy and Annovera) to Mayne Pharma for U.S. commercialization
• 2023: Mayne Pharma assumes full commercial responsibility; distribution networks transition
• 2024–2025: Intermittent pharmacy-level stocking gaps reported across multiple regions
• 2026: No FDA-listed shortage, but practical availability remains inconsistent at retail pharmacies

The manufacturer transition, combined with Bijuva's brand-only status and 24 active patents, has contributed to a fragmented supply landscape. Wholesale availability is generally adequate, but many retail pharmacies — particularly large chains — do not routinely stock the product.

Prescribing Implications

The availability situation creates several clinical considerations for prescribers:

Patient Adherence Risks

When patients cannot easily fill their Bijuva prescription, gaps in therapy are common. Interruptions in menopausal hormone therapy can lead to symptom recurrence and patient frustration. Providers should proactively discuss contingency plans when prescribing Bijuva.

Dosage Considerations

Bijuva is available in two strengths: 0.5 mg estradiol/100 mg progesterone and 1 mg estradiol/100 mg progesterone. The prescribing information recommends starting with the lower dose and titrating up based on clinical response. Both strengths may face similar availability constraints.

Formulary and Prior Authorization

Many commercial insurance plans and Medicare Part D formularies require prior authorization for Bijuva, and some mandate step therapy with a less expensive combination HRT product (e.g., generic Activella or Prempro) before approving Bijuva. Providers should be prepared to document clinical rationale for Bijuva-specific therapy, particularly the FDA-approved bioidentical combination aspect.

Current Availability Picture

Key data points for providers counseling patients:

• FDA shortage status: Not listed as of Q1 2026
• Manufacturing: Single-source (Mayne Pharma); no approved generic alternatives
• Wholesale availability: Generally available through major distributors (McKesson, AmerisourceBergen, Cardinal Health)
• Retail pharmacy stocking: Inconsistent — many chain pharmacies do not routinely carry it
• Specialty/independent pharmacies: More likely to stock or special-order
• Mail-order: Available through most major PBM mail-order programs

Cost and Access Landscape

Cost is a significant barrier to access for many patients:

• Average cash price: $257–$351 for 30 capsules (one-month supply)
• Mayne Pharma Copay Savings Card: Commercially insured patients may pay as little as $35/month; uninsured or cash-paying patients may pay as little as $75/month
• Discount programs (GoodRx, SingleCare): Typically $240–$320/month
• No generic available: 24 patents remain active; generic timeline uncertain

By comparison, generic Estradiol tablets (1 mg) plus generic Progesterone capsules (100 mg) taken as separate prescriptions typically cost $25–$70/month combined, making this the most cost-effective bioidentical alternative.

Tools and Resources for Your Practice

Several resources can streamline patient access to Bijuva:

Medfinder for Providers

Medfinder allows providers and their staff to search for pharmacies with Bijuva in stock near the patient's location. This is particularly useful when patients report difficulty filling their prescription.

Manufacturer Resources

• Bijuva Copay Savings Card: Available at bijuva.com/savings.php — instruct patients to present this at the pharmacy
• Mayne Pharma Patient Support: 1-844-825-8500 for availability assistance
• HCP Resources: Clinical information and sample requests at bijuva.com/hcp

Patient Assistance Programs

For patients with financial hardship, the following resources may help:

• Mayne Pharma Patient Savings Program
• NeedyMeds (needymeds.org) — searchable database of assistance programs
• RxAssist (rxassist.org) — comprehensive directory of patient assistance programs

Clinical Alternatives When Bijuva Is Unavailable

When Bijuva cannot be obtained, consider these therapeutic alternatives:

1. Separate Estradiol + Progesterone prescriptions: Generic oral Estradiol (0.5–1 mg daily) plus generic micronized Progesterone/Prometrium (100 mg daily). Same bioidentical hormones; more affordable and widely available. Note: Prometrium contains peanut oil.
2. Activella (Estradiol/Norethindrone Acetate): Generic available. Uses bioidentical estradiol with a synthetic progestogen. Approved for vasomotor symptoms, vaginal atrophy, and osteoporosis prevention.
3. Prempro (Conjugated Estrogens/Medroxyprogesterone): Generic available. Uses conjugated estrogens with synthetic progestogen. Most extensive long-term safety data (WHI).
4. Premphase: Cyclic regimen of conjugated estrogens plus medroxyprogesterone. May be preferred for patients who tolerate cyclic progestogen better.

For a patient-facing version of this information, see our article on alternatives to Bijuva.

Looking Ahead

Several trends will shape Bijuva access in the coming years:

• Patent landscape: With 24 active patents and at least one Paragraph IV challenge filed, generic entry is possible but likely several years away.
• Market dynamics: Continued growth in bioidentical HRT demand may push Mayne Pharma to expand manufacturing capacity and distribution.
• Telehealth integration: Telehealth platforms increasingly prescribe menopausal HRT, which could drive both demand and the development of better pharmacy network solutions.
• Compounding competition: The FDA's ongoing evaluation of compounded bioidentical hormones may affect market dynamics for products like Bijuva.

Final Thoughts

Bijuva remains an important option in the menopausal HRT toolkit — it is the only FDA-approved bioidentical estradiol/progesterone combination, and many patients specifically seek it out. However, prescribers should set realistic expectations about availability, proactively discuss cost-saving strategies, and have alternative treatment plans ready.

Use Medfinder for Providers to help your patients locate Bijuva in stock, and direct patients to our guides on finding Bijuva and saving on Bijuva for additional support.