Last updated: February 22, 2026
What Is NDC 59651-0007?
NDC 59651-0007 refers to a specific drug product listed under the National Drug Code (NDC) system. According to the FDA’s NDC Directory, this code aligns with Imvexxy (estradiol vaginal inserts), a hormone therapy for menopausal women. The drug is produced by TherapeuticsMD.
Market Overview
Indication and Usage
- Used primarily for moderate to severe vulvar and vaginal atrophy in postmenopausal women.
- Market size influenced by aging population and menopause prevalence.
Competitive Landscape
- Related products include including other vaginal estrogen therapies:
- Estrace (estradiol)
- Femring (estradiol acetate)
- Estring (estradiol ring)
- Market share is divided among branded and generic formulations.
Market Size and Trends
- The U.S. menopausal hormone therapy market was valued at approximately USD 2 billion in 2022.
- CAGR estimated at 4.2% (2022–2027), driven by increasing awareness and aging population.
- Imvexxy launched commercially in 2017, capturing early mover advantage in vaginal estrogen inserts.
Market Dynamics
- Adoption driven by preferences for localized estrogen therapies.
- Competition from generic estradiol formulations increasing.
- Prescriptions projected to grow annually by 5% through 2027.
- Payer coverage and formulary inclusion favor branded product due to specific delivery mechanism and formulation.
Price Analysis
Current Pricing Landscape
- The average wholesale price (AWP) for Imvexxy ranges between USD 1,000 to USD 1,200 per 30-count carton.
- The average sales price (ASP) reported to payers is approximately USD 900 per package, after discounts.
- Private insurers cover most prescriptions with copayments averaging USD 30–50.
Competitive Pricing
| Product |
Formulation |
Approximate AWP |
Launch Year |
Notes |
| Imvexxy (NDC 59651-0007) |
Estradiol vaginal insert (4 mcg) |
USD 1,150 |
2017 |
First in class for insert |
| Estrace |
Oral or vaginal cream |
USD 340– USD 400 (cream) |
1978 |
Widely used, less expensive |
| Femring |
Vaginal ring |
USD 1,200 |
2009 |
Continuous delivery |
| Estring |
Vaginal ring |
USD 1,100 |
1999 |
Replaced by newer options |
Price Projections (Next 5 Years)
- Short-term, pricing is likely to stabilize with slight declines due to generic competition.
- Prices could drop 10-20% by 2028, paralleling similar branded drugs facing generic entry.
- Discounts and rebates could further lower net prices to payers and pharmacy benefit managers.
External Factors Impacting Price
- Patent status: Patent expiration anticipated around 2028.
- Regulatory approvals: New formulations or delivery methods could influence pricing dynamics.
- Payment policies: CMS and private insurers' coverage decisions impact net revenues.
Regulatory and Reimbursement Considerations
- Imvexxy is FDA-approved with patent protection, limiting immediate generics.
- Private insurers largely reimburse, with formulary changes influencing utilization.
- CMS coverage policies enable widespread access for Medicare beneficiaries under Part D.
Market and Price Outlook Summary
| Parameter |
Current Status |
5-Year Projection |
| Market size |
USD 2 billion (2022) |
USD 2.4 billion (2027) |
| Price per unit |
USD 900–1,200 per package |
Slight decline, USD 800–1,000 |
| Generics impact |
Limited at present |
Significant by 2028, reducing prices |
| Regulatory exclusivity |
Patent through 2028 |
Post-patent expiration, increased competition |
Key Considerations
- Entry of generics after patent expiry will substantially lower prices.
- Market expansion possible into younger women if broader indications approved.
- Competitive pressure from alternative hormone delivery routes.
Key Takeaways
- NDC 59651-0007, Imvexxy, holds a niche in localized hormone therapy for menopause.
- Market value is driven by demographic trends, with steady growth.
- Current prices are stable but expected to decline post-patent expiry.
- Competition from generics and other hormone therapies is a significant downward force on prices.
- Payer policies and formulary decisions shape access and revenue.
FAQs
1. When is patent expiration for Imvexxy?
Patent expiration is expected around 2028, enabling generic competition.
2. How does Imvexxy compare in price to its competitors?
It is priced higher than many generic estradiol products, reflecting its delivery system and branding.
3. What factors could influence future prices?
Patent expiry, approval of generics, market entry of new formulations, and payer reimbursement policies.
4. Is there a potential for significant market growth?
Yes, demographic trends support growth, especially if expanded indications approved.
5. How do private insurance policies affect pricing?
They facilitate access but also contribute to price compression due to negotiated discounts and rebates.
References
- FDA National Drug Code Directory. (2023). Retrieved from https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm
- IQVIA. (2022). National Prescription Audit.
- MarketWatch. (2022). Menopausal hormone therapy market valuation and growth.
- US Food and Drug Administration (FDA). (2017). Approval of Imvexxy.
- CMS. (2023). Medicare coverage and payment policies.
