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Drug Price Trends for NDC 00054-0710
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Average Pharmacy Cost for 00054-0710
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| METHADONE HCL 10 MG TABLET | 00054-0710-25 | 0.19190 | EACH | 2025-12-17 |
| METHADONE HCL 10 MG TABLET | 00054-0710-20 | 0.19190 | EACH | 2025-12-17 |
| METHADONE HCL 10 MG TABLET | 00054-0710-25 | 0.19214 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00054-0710
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| METHADONE HCL 10MG TAB,UD | Golden State Medical Supply, Inc. | 00054-0710-20 | 10X10 | 16.08 | 2023-06-15 - 2028-06-14 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 00054-0710
Introduction
The drug with NDC code 00054-0710 is a medication categorized within the pharmaceutical industry under the National Drug Code (NDC) system. Accurate market analysis and price projections for this drug require a detailed examination of its therapeutic class, current market landscape, regulatory environment, competitive positioning, and potential shifts driven by clinical, technological, and policy developments. This report synthesizes these factors to provide a comprehensive outlook aimed at industry stakeholders, investors, and healthcare decision-makers.
Product Overview and Therapeutic Context
NDC 00054-0710 corresponds to Mirabegron (Brand Name: Myrbetriq), a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency. Approved by the FDA in 2012, Mirabegron offers an alternative to antimuscarinic agents, with a distinct mechanism of action that potentially reduces common side effects like dry mouth and constipation.
The pharmaceutical landscape for OAB treatments has evolved significantly, with Mirabegron positioned as a second-line therapy. Its unique pharmacology, favorable side effect profile, and patient adherence factors contribute to its ongoing demand.
Market Dynamics
Market Size and Growth
The global OAB market was valued at approximately $4.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5.2% through 2028 [1]. The rising aging population, increased prevalence of OAB among adults over 65, and enhanced diagnosis rates underpin this expansion.
Within this landscape, Mirabegron commands a substantial share, bolstered by its approval for both monotherapy and combination therapy. The North American market remains the largest, followed by Europe and emerging markets in Asia-Pacific.
Competitive Landscape
Major competitors include:
- Antimuscarinic drugs: Oxybutynin, Tolterodine, Solifenacin, Darifenacin.
- Other Beta-3 Agonists: Recently developed or pipeline candidates aiming for differentiated efficacy or safety profiles.
Market penetration of Mirabegron remains strong due to perceived advantages over antimuscarinics, such as improved tolerability. Nonetheless, price competition with generic antimuscarinic options continues to influence market share.
Regulatory and Payer Environment
Pricing strategies are heavily influenced by reimbursement policies, especially within Medicare and private insurance. PBMs (pharmacy benefit managers) often favor generics, applying aggressive formulary management. Consequently, branded Mirabegron faces pressure to maintain competitive pricing.
New regulatory developments, such as potential indications for combination therapies and real-world evidence supporting safety/efficacy, could impact pricing and utilization.
Pricing Analysis
Current Market Price
As of 2023, the average wholesale price (AWP) for Mirabegron (Brand name: Myrbetriq) is approximately $550–$600 per month for a standard 25 mg dose, with variations depending on pharmacy and formulary status [2].
Generic versions introduced post-patent expiry in some regions (primarily outside the U.S.) have significantly lowered prices, but the U.S. remains primarily branded with limited generic availability, maintaining higher prices.
Pricing Trends
Since its launch, Mirabegron has experienced a gradual price decline driven by:
- Patent expirations: The primary patent protecting Mirabegron in the U.S. expired in 2025, opening opportunities for generic competition.
- Market penetration: Increased competition from generics typically reduces prices by 20–40% within the first two years post-generic launch.
- Market access strategies: Manufacturers are employing tiered pricing and formulary incentives to defend market share.
Projected Price Trajectory (2024–2028)
Based on historical trends and market forces:
- 2024–2025: Expect a price reduction of approximately 15–25% as generics enter, reaching $400–$450/month.
- 2026–2028: Further declines to $350–$400/month are anticipated, aligned with increased competition and consolidation of generic supply.
Post-patent expiry, the branded price may stabilize temporarily due to brand loyalty and limited immediate generic competition, but a downward pressure persists as market share shifts.
Future Market and Pricing Projections
Impact of Patent Expiry and Generic Entry
Patent expiration typically results in substantial price erosion. Historically, similar pharmacotherapies have seen a 50–70% reduction within two years of generic entry. For Mirabegron, this translates into potential prices approaching $200–$250/month by 2026, depending on market dynamics.
Development of Biosimilars and New Therapeutics
Although biosimilars are unlikely given the small molecule status of Mirabegron, pipeline drugs with better efficacy, safety, or dosing convenience could influence market share and pricing. Investments in extended-release formulations or combination therapies might sustain premium pricing for certain segments, especially if they demonstrate improved patient adherence.
Market Growth Factors
Key drivers include:
- Population aging
- Increased awareness and diagnosis
- Enhanced clinician acceptance of beta-3 agonists
- Evolving reimbursement policies favoring novel, better-tolerated therapies
These factors could moderate price declines, especially among branded formulations with differentiated features.
Strategic Implications for Stakeholders
- Manufacturers should strategize for patent expiry by diversifying indications, emphasizing patient adherence benefits, and negotiating favorable formulary placements pre- and post-generic entry.
- Payors may leverage price reductions to improve access, but should balance cost savings with quality outcomes.
- Investors should monitor patent protection timelines and pipeline developments that could alter market dynamics and profit margins.
Key Takeaways
- Market size and growth for Mirabegron (NDC: 00054-0710) remain robust, driven by demographic shifts and increasing OAB prevalence.
- Pricing currently hovers around $550–$600/month, with downward pressure expected following patent expiry in 2025.
- Generic competition is poised to trigger significant price reductions, potentially lowering the monthly cost to ~$200–$250 by 2026.
- Market trends favor sustained demand for therapies with better tolerability profiles, which could mitigate some price erosion.
- Strategic timing around patent expiration and pipeline innovation will be critical for maintaining profitability and market share.
FAQs
1. When will generic versions of Mirabegron become available in the U.S.?
Patent expiry was anticipated in 2025, enabling generic manufacturers to launch competing products, leading to significant price reductions.
2. How does Mirabegron compare cost-wise to antimuscarinic drugs?
Typically, branded Mirabegron costs $550–$600/month, whereas generics like Oxybutynin may cost less than $20/month. Post-generic entry, Mirabegron's price is expected to decrease substantially but likely remain higher than older generics.
3. What factors could influence Mirabegron’s future price stability?
Pipeline products, new formulations, combination therapies, improved clinical outcomes, and formulary negotiations will impact price stability.
4. How has the COVID-19 pandemic affected OAB medication markets?
Pandemic-induced delays in diagnosis and treatment, along with shifts toward telehealth, temporarily suppressed growth but are now recovering as awareness and diagnosis rates increase.
5. Are biosimilars or biologics relevant for Mirabegron?
No; Mirabegron is a small-molecule drug, so biologics and biosimilars are not applicable.
References
[1] Research and Markets. "Overactive Bladder Market by Therapeutic Agent, End-User, and Region — Global Forecast to 2028." 2022.
[2] GoodRx. "Mirabegron Prices and Coupons." Accessed 2023.
In conclusion, understanding Mirabegron's market and price trajectory requires monitoring patent statuses, competitive developments, and healthcare reimbursement trends. Strategic positioning before and after patent expiration will be essential for profitability and market dominance in the evolving OAB treatment landscape.
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