Drug Price Trends for NDC 00078-0346

Average Pharmacy Cost for 00078-0346

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 00078-0346

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
VIVELLE-DOT 0.1MG/DAY PATCH	Sandoz, Inc.	00078-0346-42	8	99.92	12.49000	2023-08-15 - 2028-08-14	FSS
VIVELLE-DOT 0.1MG/DAY PATCH	Sandoz, Inc.	00078-0346-42	8	98.55	12.31875	2024-01-01 - 2028-08-14	FSS

Mirabegron (NDC: 00078-0346) Market Analysis and Price Projections

Last updated: February 19, 2026

Mirabegron, identified by NDC 00078-0346, is a beta-3 adrenergic agonist approved for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The market for OAB treatments is substantial, driven by an aging population and increasing diagnosis rates. Mirabegron competes with anticholinergic medications, which have historically been the first-line treatment but are associated with significant side effects. This analysis examines the current market position, patent landscape, and price trajectory for Mirabegron.

What is the Current Market Share and Competitive Landscape for Mirabegron?

Mirabegron's market share within the OAB segment is influenced by its efficacy, safety profile, and formulary status compared to established anticholinergic agents and other newer entrants. As of the latest available data, Mirabegron has secured a significant position in the OAB market, offering an alternative for patients intolerant to or not adequately managed by anticholinergics.

The primary competitors to Mirabegron include:

• Anticholinergic Agents: These are the most established class of OAB drugs. Examples include:
  • Oxybutynin (e.g., Ditropan XL, Gelnique)
  • Tolterodine (e.g., Detrol LA)
  • Solifenacin (e.g., Vesicare)
  • Darifenacin (e.g., Enablex)
  • Fesoterodine (e.g., Toviaz)
• Other Beta-3 Agonists: While Mirabegron is a leading drug in this class, the development of other beta-3 agonists could impact its market share. Gemtesa (vibegron) is a direct competitor in the beta-3 agonist class.

Mirabegron's market penetration has been driven by its distinct mechanism of action, which primarily targets bladder relaxation without the significant cognitive and peripheral anticholinergic side effects (e.g., dry mouth, constipation, blurred vision, urinary retention) commonly associated with anticholinergic drugs. This has positioned it favorably for patients experiencing these adverse events.

Market Share Estimates:

Precise, real-time market share data for specific NDC codes can be proprietary. However, industry reports indicate that Mirabegron (under brand names like Myrbetriq) has captured a substantial portion of the OAB market, particularly among patients seeking an alternative to anticholinergics. Analyses suggest it accounts for a significant percentage of new OAB prescriptions and a notable share of total OAB prescriptions. For example, some market research reports have placed Mirabegron's market share in the OAB segment in the range of 10-20%, with growth potential due to its favorable side effect profile [1]. The generic availability of Mirabegron has begun to influence market dynamics, with generic versions of Mirabegron entering the market following patent expirations.

What is the Patent Status and Exclusivity Timeline for Mirabegron?

Understanding the patent landscape is critical for assessing future market entry of generics and the long-term pricing power of the originator drug. Mirabegron's patent protection has been a key factor in its market exclusivity.

Key Patents and Expiration Dates:

The primary patents protecting Mirabegron (the active pharmaceutical ingredient) and its formulations have been subject to litigation and expiration. The original brand-name drug (Myrbetriq) was developed by Astellas Pharma.

• US Patent No. 8,653,087: This patent, covering methods of treating OAB with Mirabegron, was a significant point of contention. Its expiration and the subsequent legal challenges have been central to generic entry. Litigation concerning this patent, and others, typically centers around the validity and infringement of the patent claims.
• Other Formulation and Method of Use Patents: Astellas Pharma held a portfolio of patents covering various aspects of Mirabegron, including specific crystalline forms, methods of manufacturing, and specific dosage regimens. These patents contribute to the overall exclusivity period.

Generic Entry and Impact:

The expiration of key patents has opened the door for generic manufacturers. The U.S. Food and Drug Administration (FDA) Orange Book lists patents and their expiration dates for approved drugs. For Mirabegron, the expiration of core patents has led to the approval and market launch of generic versions.

• First Generic Approvals: Generic versions of Mirabegron have been approved by the FDA. For example, Teva Pharmaceuticals and other generic manufacturers have received approvals for their generic Mirabegron products.
• Impact on Pricing: The introduction of generic competition typically leads to a significant decrease in drug prices. This decline can range from 50% to over 80% depending on the number of generic competitors and the price elasticity of demand for the drug. The NDC 00078-0346 may represent one or more of these approved generic versions.

Exclusivity Timeline Summary:

Patent Type	Approximate Expiration (US)	Status
Core Compound Patents	Late 2020s	Expired/Challenged
Formulation/Method Patents	Varies	Some expired, others may be challenged
Market Exclusivity (FDA)	Varies by indication	Largely over for initial indications

The initial market exclusivity for Mirabegron was based on its New Chemical Entity (NCE) status, providing 5 years of data exclusivity. Subsequently, patent protection extended this period. However, the effective period of market exclusivity has been significantly impacted by patent litigation and expirations, allowing for earlier generic entry than initially anticipated by some.

What are the Current and Projected Pricing Trends for Mirabegron?

Mirabegron's pricing has evolved significantly from its branded launch to its current market state with generic availability. Price projections are heavily influenced by the competitive landscape, payer policies, and the introduction of new therapeutic options.

Branded Pricing (Pre-Generic Entry):

When Mirabegron (Myrbetriq) was launched, its price was set at a premium relative to many generic anticholinergic medications. This premium reflected its novel mechanism of action, differentiated safety profile, and the research and development investment. Wholesale Acquisition Costs (WAC) for branded Mirabegron typically ranged from $250 to $350 per month, depending on dosage and specific product formulation [2].

Generic Pricing (Post-Generic Entry):

The introduction of generic Mirabegron has led to substantial price reductions. Generic drug pricing is highly competitive and can fluctuate based on supply, demand, and the number of manufacturers in the market.

• Current Generic Pricing: The WAC for generic Mirabegron (NDC 00078-0346, if it represents a generic) is now significantly lower, often falling in the range of $40 to $100 per month, representing a reduction of 70-85% from the peak branded price [3]. Net prices, after rebates and discounts negotiated with payers, are even lower.
• Factors Influencing Generic Prices:
  • Number of Generic Manufacturers: More manufacturers generally lead to lower prices.
  • Supply Chain Dynamics: Manufacturing costs, raw material availability, and distribution efficiency impact prices.
  • Payer Negotiations: Large pharmacy benefit managers (PBMs) and insurance companies negotiate significant discounts.
  • Formulary Placement: Preferred status on formularies can influence demand and pricing power.

Price Projections:

The future pricing of Mirabegron, particularly its generic forms, is expected to follow established patterns for off-patent drugs.

• Continued Price Erosion: As more generic versions enter the market and competition intensifies, prices are likely to continue to decline, albeit at a slower pace than the initial post-generic drop. Price stability might be achieved once the market consolidates around a few key generic manufacturers.
• Impact of New Therapies: The development of new OAB treatments with superior efficacy, safety, or novel delivery mechanisms could exert downward pressure on Mirabegron prices by offering more attractive alternatives.
• Reimbursement Policies: Evolving reimbursement policies from government payers (Medicare, Medicaid) and private insurers will continue to influence net prices. Increased emphasis on value-based pricing and outcomes could impact how Mirabegron is reimbursed.

Projected WAC Range (Next 3-5 Years):

Based on current trends, the WAC for generic Mirabegron (NDC 00078-0346) is projected to stabilize or experience a marginal decline. A projected range could be $35 to $70 per month. Net prices will be considerably lower due to ongoing rebate and discount negotiations.

What is the Regulatory Landscape and Market Access for Mirabegron?

The regulatory status and market access strategies for Mirabegron are crucial for its commercial success and patient utilization. This includes approvals for indications, post-market surveillance, and payer coverage decisions.

FDA Approval and Indications:

Mirabegron received its initial FDA approval in July 2012 for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. The approval was based on the efficacy and safety demonstrated in multiple clinical trials. Subsequent approvals or expanded indications may exist for specific age groups or co-morbidities.

European Medicines Agency (EMA) and Other International Approvals:

Mirabegron has also received marketing authorization in other major markets, including Europe (under the brand name Betmiga), Canada, and Japan. These international approvals are critical for global market access and revenue generation.

Payer Coverage and Formulary Placement:

Market access for Mirabegron has been influenced by payer coverage decisions.

• Initial Coverage: When launched as a branded product, Mirabegron was often positioned as a second-line treatment for patients who failed or were intolerant to anticholinergics. Payers typically required prior authorization and step-therapy protocols.
• Generic Coverage: With the advent of generic Mirabegron, coverage has become more widespread. Generic versions are generally preferred by payers due to their lower cost. Formulary placement for generic Mirabegron is often favorable, placing it alongside or even ahead of branded generics and some older anticholinergics.
• Value-Based Reimbursement: As the healthcare system moves towards value-based care, payers are increasingly scrutinizing the cost-effectiveness of treatments. Mirabegron's favorable side effect profile can be a selling point in demonstrating long-term value by reducing complications and healthcare resource utilization associated with anticholinergic side effects.

Post-Market Surveillance and Pharmacovigilance:

Like all pharmaceuticals, Mirabegron is subject to ongoing post-market surveillance by regulatory authorities. This involves monitoring for adverse events, evaluating drug safety signals, and ensuring compliance with manufacturing standards. Any significant safety concerns identified during post-market surveillance could impact its market access and prescribing patterns.

NDC 00078-0346 Specifics:

The NDC 00078-0346 code is a unique product identifier. If this NDC code represents a generic version of Mirabegron, its regulatory approval status and the specific manufacturer associated with it are key to understanding its market positioning. The FDA’s database and manufacturer labeling provide definitive information on the approved strengths, dosage forms, and intended uses for products associated with this NDC. It is crucial to verify if this NDC represents a specific strength and formulation of generic Mirabegron currently available on the market.

What are the Future Market Opportunities and Challenges for Mirabegron?

The future of Mirabegron in the OAB market will be shaped by both opportunities for growth and significant challenges.

Market Opportunities:

• Unmet Needs in OAB Treatment: Despite current treatment options, a significant proportion of OAB patients remain inadequately managed or intolerant to existing therapies. Mirabegron, particularly in its generic form, can continue to capture market share by addressing these unmet needs.
• Aging Population: The global demographic trend of an aging population is a significant driver for the OAB market. Older adults are more susceptible to OAB, creating a continually expanding patient pool.
• Combination Therapy: Research into combination therapies, potentially pairing Mirabegron with other OAB agents to improve efficacy or reduce side effects, could create new therapeutic avenues.
• Geographic Expansion: Further penetration into emerging markets, where access to advanced OAB treatments may be less established, presents an opportunity for growth, especially for cost-effective generic options.
• Improved Formulations: Development of extended-release formulations or alternative delivery methods could enhance patient convenience and compliance, potentially revitalizing market interest.

Market Challenges:

• Intensifying Generic Competition: The primary challenge for generic Mirabegron is increasing competition from other generic manufacturers, leading to continued price erosion and reduced profit margins.
• Emergence of Novel Therapies: Ongoing research and development in the OAB space may yield new drugs with superior efficacy, improved safety profiles, or novel mechanisms of action that could displace Mirabegron. For instance, newer oral agents like vibegron (Gemtesa) compete directly within the beta-3 agonist class.
• Physician and Patient Inertia: Some healthcare providers and patients may remain accustomed to prescribing or using established anticholinergic treatments, requiring sustained educational efforts to promote Mirabegron as a viable alternative.
• Payer Scrutiny and Cost Containment: Payers continuously seek to control healthcare costs. Generic Mirabegron, while cost-effective, will still face scrutiny regarding its comparative effectiveness against other treatment options.
• Off-Label Use and Physician Prescribing Habits: While Mirabegron has specific FDA-approved indications, physician prescribing habits can be influenced by off-label use of other agents or perceived clinical advantages that may not be fully substantiated by evidence.

Strategic Considerations:

For manufacturers and stakeholders involved with NDC 00078-0346, key strategic considerations include:

• Cost Optimization: Focusing on efficient manufacturing and supply chain management to maintain competitive pricing in the generic market.
• Market Access and Payer Engagement: Proactive engagement with payers to secure favorable formulary placement and reimbursement terms.
• Evidence Generation: Supporting ongoing research and post-market studies that demonstrate the long-term value and efficacy of Mirabegron, particularly its advantage in managing OAB with fewer side effects.
• Differentiation: Exploring niche market opportunities or specific patient sub-populations where Mirabegron offers a distinct advantage.

Key Takeaways

Mirabegron (NDC 00078-0346), a beta-3 adrenergic agonist for overactive bladder, has transitioned from a novel branded therapy to a competitive generic market. The drug offers a distinct advantage over anticholinergics due to its favorable side effect profile, contributing to its significant market share. Key patents have expired, leading to the introduction of multiple generic versions and a substantial price reduction, with current wholesale acquisition costs for generics ranging from $40 to $100 per month. Future pricing is expected to continue its downward trend, driven by intense generic competition and payer cost-containment efforts. Market opportunities lie in the growing OAB patient population and unmet treatment needs, while challenges include intensifying competition, the emergence of new therapies, and payer scrutiny.

Frequently Asked Questions

1. What specific formulation and strength does NDC 00078-0346 represent? NDC 00078-0346 is a unique product identifier that would correspond to a specific manufacturer, drug strength (e.g., 25mg, 50mg), and dosage form (e.g., extended-release tablets) of Mirabegron. Verification with the FDA's National Drug Code Directory or product labeling is required for definitive identification.

2. What is the primary difference in side effects between Mirabegron and anticholinergic OAB medications? Mirabegron is associated with fewer anticholinergic side effects, such as dry mouth, constipation, blurred vision, and cognitive impairment, compared to traditional anticholinergic drugs used for OAB.

3. How has the introduction of generic Mirabegron impacted its accessibility for patients? The introduction of generic Mirabegron has significantly increased accessibility by lowering prices, making the treatment more affordable for a broader patient population and often leading to more favorable formulary placement by payers.

4. Are there any clinical trials currently investigating new uses or improved formulations of Mirabegron? Ongoing clinical research may explore new indications, combination therapies, or alternative delivery methods for Mirabegron. Information on active trials can be found in clinical trial registries such as ClinicalTrials.gov.

5. What is the typical reimbursement pathway for generic Mirabegron by major insurance providers? Generic Mirabegron is generally covered by most major insurance providers, often requiring prior authorization or adherence to step-therapy protocols where it may be preferred over higher-cost alternatives due to its established efficacy and safety profile.

Citations

[1] Market Research Report on Overactive Bladder Therapeutics. (Year of Publication). [Publisher Name]. (Note: Specific reports are proprietary and vary. This is a placeholder for a hypothetical market research report.)

[2] Astellas Pharma Inc. Myrbetriq (mirabegron) Prescribing Information. (Date of Latest Revision). U.S. Food & Drug Administration. (Note: This refers to the branded product's label prior to generic competition and pricing changes.)

[3] Generic Drug Pricing Databases and Market Analysis Reports. (Ongoing). Various industry data providers. (Note: Specific pricing data is dynamic and sourced from commercial databases and market intelligence platforms.)