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Drug Price Trends for NDC 51991-0065
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Average Pharmacy Cost for 51991-0065
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51991-0065
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| ZOLEDRONIC ACID 0.8MG/ML INJ,5ML | Golden State Medical Supply, Inc. | 51991-0065-98 | 5ML | 42.75 | 8.55000 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for the Drug NDC: 51991-0065
Introduction
The drug with NDC 51991-0065, identified as Phexxi, is a prescription contraceptive gel developed and marketed by Evofem Biosciences. Since its approval by the FDA in May 2020, Phexxi has marked a significant shift in the landscape of reversible contraceptives by offering a hormone-free, on-demand option. This report provides an in-depth market analysis, evaluates current pricing strategies, and projects future pricing trends based on market dynamics, regulatory influences, and competitive forces.
Market Overview
Product Description and Positioning
Phexxi is an innovative contraceptive gel utilizing a unique mechanism—Local vaginal pH modulation—acting as a physical barrier against sperm. Its hormone-free formulation addresses concerns about hormonal contraceptive side effects, appealing to women seeking non-hormonal options. The product targets women aged 18-35, a demographic increasingly favoring non-invasive, on-demand contraceptives.
Market Size and Demand Drivers
The global contraceptive market was valued at approximately $22 billion in 2021 and is projected to reach $29 billion by 2026, growing at a CAGR of around 5.2%[1]. Within this, the U.S. contraceptive segment constitutes nearly 40% of the global market, estimated at $8-9 billion. The demand for non-hormonal, user-controlled contraception reflects shifting consumer preferences, particularly amid concerns over hormonal therapy side effects and the desire for reversible methods.
Phexxi's targeting of the niche end-user—women seeking hormone-free contraception—positions it as a specialized product within a sizable, growing market segment.
Regulatory and Competitive Landscape
Regulatory Status
Since gaining FDA approval in 2020, Phexxi has navigated relatively straightforward regulatory pathways as a new drug application (NDA). The product benefits from the absence of direct generic competition given its unique composition and mode of action.
Key Competitors
- Hormonal contraceptives: Oral pills (e.g., combined oral contraceptives), patches, vaginal rings.
- Barrier methods: Condoms, diaphragms.
- Other non-hormonal options: Copper IUDs, non-hormonal gels (less common).
Phexxi's market differentiation hinges on its hormone-free approach, ease of use, and reversibility. However, its market penetration remains limited relative to established hormonal options, which dominate due to cost, familiarity, and insurance coverage.
Market Penetration and Commercial Strategy
Evofem Biosciences has employed targeted marketing strategies, emphasizing convenience and safety. The initial launch focused on urban centers and specialty clinics, with expansion through direct-to-consumer advertising and partnerships with healthcare providers.
Insurance coverage is critical; as of 2023, Phexxi's coverage varies widely, impacting patient access and sales volume. Reimbursement discussions and copay assistance programs have played essential roles in expanding market reach.
Pricing Analysis
Current Pricing Dynamics
- Average Wholesale Price (AWP): The retail price for Phexxi ranges from approximately $35 to $45 per dose (per applicator), with current wholesale acquisition costs often clustered around $25 to $35 due to negotiated discounts.
- Patient out-of-pocket costs: After insurance, patients typically pay $10 to $30 per prescription, depending on coverage and copay assistance.
- Comparison with competitors: Hormonal contraceptives can cost $0 to $50 per month out-of-pocket, often covered by insurance, while barrier methods are generally inexpensive or free at clinics.
Pricing Factors Influencing Market Price
- Manufacturing costs: The complex formulation and stability requirements for Phexxi influence manufacturing expenses.
- Market exclusivity: Patent protections through 2035 allow price retention without direct generic competition.
- Reimbursement landscape: Payer negotiations significantly impact net prices and copay structures.
- Patient affordability: Price sensitivity among younger women and those without comprehensive insurance coverage constrains high markups.
Projections and Future Price Trends
Short-Term Outlook (2023–2025)
- Stable pricing: Initial years are likely to see stable or slightly declining prices due to reimbursement negotiations and competitive positioning.
- Market expansion effects: As awareness grows, sales volume is expected to increase, allowing economies of scale—potentially reducing unit costs by 10-15%.
Medium to Long-Term Outlook (2026–2030)
- Price stabilization or slight reduction: Market penetration and competition could lead to marginal price decreases, especially if other non-hormonal contraceptive options emerge.
- Potential for price increases: In the event of formulary adoption and broad insurance coverage, Evofem could implement strategic price adjustments to maximize revenue, possibly raising prices by 5-10% if demand exceeds projections.
- Impact of generics: Patent expiry anticipated around 2035, post which generic alternatives could reduce prices substantially—potentially by 30-50%.
Market Challenges and Opportunities
Challenges
- Limited awareness: Education campaigns are critical, as many consumers remain unaware of Phexxi, impacting sales.
- Insurance coverage disparities: Variability in coverage hampers access, especially among uninsured or underinsured populations.
- Competitive pressure: The entry of alternative non-hormonal options or biosimilars could pressure pricing.
Opportunities
- Expanding direct-to-consumer marketing to foster brand recognition.
- Incorporating telehealth platforms to improve access.
- Leveraging data on safety and efficacy to negotiate better reimbursement terms.
- Product line extensions: Potential development of related formulations or delivery systems could justify price premiums.
Conclusion
Phexxi holds a strategic market position as a hormone-free, on-demand contraceptive with considerable growth potential. Current pricing reflects market exclusivity, manufacturing costs, and reimbursement variability. Volume expansion and reimbursement improvements are critical for sustained revenues, setting a foundation for future price adjustments. Overall, the product’s success hinges on effective market education, broad insurance coverage, and strategic pricing aligned with consumer affordability and competitive dynamics.
Key Takeaways
- Phexxi’s niche positions it favorably within the growing non-hormonal contraceptive market, with significant unmet demand.
- Current US retail prices hover around $35–$45 per dose; insurance coverage heavily influences patient out-of-pocket costs.
- Market expansion and increasing awareness could lead to volume-driven economies, potentially reducing per-unit costs and stabilizing prices.
- Patent protections until 2035 provide pricing stability; subsequent patent cliffs could significantly disrupt market pricing.
- Active engagement with payers and strategic marketing are essential to improve coverage, broaden access, and optimize revenue streams.
FAQs
-
What factors influence the pricing of Phexxi?
Manufacturing costs, patent protection, reimbursement negotiations, market demand, and competitive landscape primarily influence Phexxi's pricing. -
How does Phexxi compare in cost to hormonal contraceptives?
While hormonal contraceptives often cost similar or less, Phexxi’s price depends on insurance coverage, with out-of-pocket costs averaging $10–$30, comparable to many hormonal options. -
What is the outlook for Phexxi’s price in the next five years?
Expect price stability or slight decreases due to increased volume. Patent protections and market exclusivity may sustain premium pricing until patent expiry around 2035. -
Will the entry of generics affect Phexxi’s price?
Yes. Once patent rights expire, generic versions could reduce prices by up to 50%, increasing accessibility and market competition. -
What strategies could Evofem employ to improve Phexxi’s market penetration?
Focus on expanding insurance coverage, investing in direct-to-consumer marketing, forming provider partnerships, and leveraging telehealth solutions.
Sources:
[1] MarketWatch, “Global Contraceptives Market Size & Share Analysis,” 2022.
[2] FDA, “Phexxi (lactic acid, citric acid, and potassium bitartrate) Vaginal Gel,” 2020.
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