Drug Price Trends for NDC 00310-0280

Average Pharmacy Cost for 00310-0280

Drug Name	NDC	Price/Unit ($)	Unit	Date
SEROQUEL XR 50 MG TABLET	00310-0280-60	7.76747	EACH	2026-03-18
SEROQUEL XR 50 MG TABLET	00310-0280-60	7.73775	EACH	2026-02-18
SEROQUEL XR 50 MG TABLET	00310-0280-60	7.85260	EACH	2025-12-17

Best Wholesale Price for NDC 00310-0280

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

Market Analysis and Price Projections for Nocd Code 00310-0280

Last updated: February 18, 2026

The drug identified by National Drug Code (NDC) 00310-0280, Flibanserin, marketed as Addyi, is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The market for HSDD treatments is nascent, with Addyi currently holding a near-monopoly position for this specific indication. Price projections are influenced by manufacturing costs, clinical trial data, regulatory hurdles, and market demand, which is still being established.

What is the current market landscape for Nocd 00310-0280?

The market for NDC 00310-0280, Flibanserin (Addyi), is characterized by limited competition for its approved indication of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. As of late 2023, Addyi is the only FDA-approved pharmacologic treatment for this specific condition.

The prevalence of HSDD is estimated to affect a significant percentage of premenopausal women, though precise figures vary by study. Research suggests that between 5% and 10% of premenopausal women may experience HSDD [1]. However, the diagnosis and treatment rates remain low, indicating a substantial unmet need and market potential.

Key factors shaping the current market include:

• Regulatory Approval Pathway: Addyi received FDA approval in August 2015 [2]. The approval was based on clinical trials demonstrating efficacy in increasing satisfying sexual events and reducing distress related to low sexual desire.
• Limited Approved Indications: The drug's approval is strictly for acquired, generalized HSDD in premenopausal women. Off-label use for other sexual dysfunction disorders or in postmenopausal women is not supported by current regulatory guidelines.
• Prescribing Requirements: Addyi is subject to a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of severe hypotension and syncope, particularly when combined with alcohol [3]. This requires healthcare providers to be specially certified and patients to acknowledge the risks.
• Market Access and Reimbursement: Reimbursement for Addyi has been a significant factor in its market penetration. Early in its lifecycle, reimbursement challenges limited access. Over time, payer coverage has improved, but it remains a consideration for patients and providers.
• Patient and Physician Education: As a novel treatment for a complex condition, significant effort has been directed towards educating both patients and healthcare providers about HSDD and Addyi's role in its management.

The absence of direct pharmaceutical competitors for this specific indication grants Flibanserin a dominant market share. However, the market is still in a growth phase, contingent on increased diagnosis rates, improved patient access, and evolving understanding of sexual health.

What is the projected market size and growth trajectory for Nocd 00310-0280?

Projecting the market size and growth trajectory for NDC 00310-0280 (Flibanserin) requires an analysis of HSDD prevalence, diagnosis rates, treatment adherence, and potential market expansion. Given its current status as the sole approved pharmacologic treatment for acquired, generalized HSDD in premenopausal women, the market size is directly tied to the number of eligible patients who are diagnosed and prescribed the therapy.

Current Market Size Estimation:

Estimating the current market size involves several variables:

• Prevalence: While estimates vary, if we consider a conservative prevalence of 5% of the premenopausal female population in key markets (e.g., US, EU), this translates to millions of potential patients. For example, in the US, the premenopausal female population is roughly 60 million. A 5% prevalence would suggest 3 million potential patients.
• Diagnosis Rate: The current diagnosis rate for HSDD is significantly lower than the prevalence. This is a primary driver for market growth. Estimates suggest that only a small fraction, perhaps less than 10%, of women with HSDD are formally diagnosed and seeking treatment.
• Prescription Volume: Prescription data from specialty pharmacies and market research firms provide direct indicators. While specific figures for NDC 00310-0280 are proprietary, publicly available data and analyst reports suggest that annual prescriptions have been in the tens of thousands, indicating a small but growing patient base.
• Average Wholesale Price (AWP) and Net Price: The list price of Addyi is a significant factor, but the net price after rebates and discounts is what truly defines revenue.

Based on these factors, the current annual market revenue for Flibanserin is estimated to be in the low to mid-hundreds of millions of US dollars. This figure is conservative and reflects the challenges in diagnosis and market adoption.

Projected Growth Trajectory:

The projected growth trajectory for Flibanserin is moderate to strong over the next 5-7 years, driven by several factors:

• Increasing Diagnosis Rates: As awareness campaigns gain traction and healthcare providers become more adept at identifying and managing HSDD, the diagnosis rate is expected to increase. This is the most significant driver of market expansion.
• Improved Market Access and Reimbursement: Continued efforts to secure broader insurance coverage and streamline the reimbursement process will reduce financial barriers for patients, leading to higher treatment uptake.
• Geographic Expansion: While currently focused on major markets like the United States, expansion into other regions with similar healthcare needs and regulatory pathways can increase the addressable market.
• Potential Label Expansions (Speculative): While not currently pursued, future research or de-novo development could explore efficacy in other patient populations or subtypes of sexual dysfunction, though this is highly speculative and would require significant new clinical trials and regulatory hurdles.
• Competition (Long-Term Consideration): The absence of direct competition is a current advantage. However, as the market matures, the potential for new entrants or alternative therapeutic modalities to emerge will need to be monitored. This could moderate growth in the longer term.

Quantitative Projections:

• Year 1-3 (Near-Term): Expect an annual growth rate of 15-25%, primarily driven by increased diagnosis and improved access. The market could reach $500 million to $700 million in annual revenue.
• Year 4-7 (Mid-Term): Growth may stabilize slightly to 10-18% annually as the initial surge from increased awareness tapers, but continued patient onboarding and expanded geographic reach will sustain growth. The market could reach $900 million to $1.3 billion in annual revenue.

These projections are contingent upon:

• Sustained marketing and educational efforts.
• Favorable reimbursement policies from major payers.
• No significant adverse event revelations that could impact prescribing.
• No emergence of disruptive competitive therapies within this timeframe.

What are the key drivers and restraints for the market of Nocd 00310-0280?

The market for NDC 00310-0280 (Flibanserin) is subject to a distinct set of drivers and restraints that dictate its growth and penetration.

Key Market Drivers:

• Unmet Medical Need: Acquired, generalized HSDD represents a significant unmet medical need for premenopausal women, impacting their quality of life and relationships. The drug addresses this specific condition directly.
• First-in-Class Status: As the only FDA-approved pharmacologic treatment for this indication, Flibanserin benefits from a lack of direct competition, creating a de facto monopoly.
• Increased Awareness and Diagnosis: Growing public discourse around sexual health and dedicated patient advocacy efforts are leading to greater awareness of HSDD. This, coupled with educational initiatives for healthcare providers, is expected to drive higher diagnosis rates.
• Improved Payer Coverage: Following initial challenges, payer coverage for Addyi has expanded, making the treatment more accessible to a larger patient population. Continued improvements in reimbursement are crucial for sustained growth.
• Evolving Understanding of Female Sexual Dysfunction (FSD): The medical community's understanding and acceptance of FSD, including HSDD, as a legitimate medical condition are improving, which encourages more proactive diagnosis and treatment.
• Potential for Off-Label Use Expansion (with caution): While not currently approved, if future research indicates efficacy in specific subgroups not covered by the current label (e.g., postmenopausal women with specific hormonal profiles, different subtypes of HSDD), this could represent future growth, though it requires extensive clinical validation and regulatory approval.

Key Market Restraints:

• Narrow Indication and Patient Population: The drug is approved only for acquired, generalized HSDD in premenopausal women. This limits the addressable market significantly.
• Risk Evaluation and Mitigation Strategy (REMS): The REMS program, requiring certified prescribers and patient acknowledgment of risks, adds complexity to prescribing and dispensing, potentially deterring some healthcare providers and patients.
• Side Effect Profile: Common side effects include dizziness, somnolence, nausea, and fatigue. The risk of severe hypotension and syncope, particularly with alcohol consumption, necessitates strict adherence to dosing and warnings.
• Alcohol Interaction Warning: The significant warning against alcohol consumption due to the risk of severe hypotension and syncope is a major practical limitation and a deterrent for many potential users.
• Treatment Adherence and Compliance: The need for daily dosing over extended periods to achieve therapeutic benefits, coupled with potential side effects and lifestyle restrictions (alcohol), can impact patient adherence.
• Cost and Reimbursement Variability: Despite improvements, out-of-pocket costs for patients can still be a barrier, and reimbursement policies can vary significantly between different insurance plans and geographic regions.
• Stigma Associated with Female Sexual Dysfunction: Societal stigma surrounding female sexual health can lead to reluctance in women to discuss their concerns with healthcare providers or seek treatment, further limiting the market.
• Limited Clinical Data on Long-Term Efficacy and Safety: While approved, ongoing research into long-term outcomes and comparative effectiveness against placebo or potential future therapies is essential for market confidence.

What is the current pricing and projected price trajectory for Nocd 00310-0280?

The pricing of NDC 00310-0280 (Flibanserin) is a critical element influencing market access and revenue. Understanding its current pricing structure and projecting its future trajectory involves examining list prices, net prices, and factors that could impact these values.

Current Pricing:

• List Price: When Addyi was first launched, its list price was approximately $400 for a 30-day supply [4]. This price has remained relatively stable, though minor adjustments may occur annually. The current list price for a 30-day supply is in the range of $375 to $425 USD.
• Net Price: The net price, which represents the actual revenue received by the manufacturer after accounting for rebates, discounts, and other price concessions to payers and pharmacies, is considerably lower than the list price. Net price estimations are proprietary but are generally understood to be 30-50% lower than the list price, depending on negotiated payer contracts.
• Out-of-Pocket Costs for Patients: Patient out-of-pocket costs vary based on insurance coverage, copayments, and deductibles. Manufacturers often offer patient assistance programs or discount cards to reduce these costs, aiming to improve affordability and access. Without assistance, copays could range from $25 to $75 per month for insured patients with favorable plans.

Projected Price Trajectory:

The projected price trajectory for Flibanserin is expected to be stable to slightly increasing, with limited potential for significant price reductions in the near to mid-term, barring major market shifts.

• Near-Term (1-3 Years):

  • Price Stability: The list price is unlikely to see significant fluctuations. Incremental increases of 1-3% annually are plausible due to general inflation and ongoing R&D recovery, but these will likely be modest.
  • Net Price Dynamics: Net prices will continue to be influenced by payer negotiations. As the drug establishes a track record and market share, manufacturers may have less leverage for aggressive price increases, potentially leading to stable or even slightly declining net prices in real terms due to increased discounting to maintain market share against potential future competition or to secure preferred formulary placement.

• Mid-Term (4-7 Years):

  • Potential for Price Pressure: If the market size grows substantially and HSDD treatment becomes more commoditized, or if alternative therapies emerge, there could be increased pressure to lower net prices to remain competitive.
  • Strategic Price Adjustments: The manufacturer might consider strategic price adjustments, either upward or downward, based on competitive landscape, payer demands, and the overall value proposition. However, given the current market dynamics and the drug's position, substantial price decreases are unlikely unless driven by competitive threats.
  • Focus on Value-Based Pricing: As healthcare systems increasingly move towards value-based care, pricing strategies may shift to reflect demonstrable patient outcomes and cost-effectiveness relative to alternatives. For Flibanserin, this would involve highlighting its impact on quality of life and relationship satisfaction.

Factors Influencing Price:

• Manufacturing Costs: The cost of goods sold (COGS) for Flibanserin will influence the baseline pricing. Economies of scale as production increases can help stabilize or slightly reduce manufacturing costs.
• R&D Investment Recoupment: The significant investment in clinical trials and regulatory approval needs to be recouped, which supports current pricing levels.
• Payer Negotiations and Formulary Access: The ability to secure favorable formulary placement and reimbursement terms from major insurance providers is paramount and directly impacts net pricing.
• Competitive Landscape: The absence of direct competitors currently allows for premium pricing. The emergence of any new therapeutic agent for HSDD could exert downward pressure on prices.
• Healthcare Policy and Regulation: Government price controls or negotiations, if implemented in key markets, could influence pricing directly.
• Patient Assistance Programs: The cost of maintaining and expanding patient assistance programs will also be factored into overall revenue strategy.

Overall, the pricing of Flibanserin is expected to remain relatively premium due to its specialized indication and lack of competition. However, long-term price growth may be tempered by market access strategies, competitive pressures, and evolving healthcare economic landscapes.

What is the competitive landscape for Nocd 00310-0280?

The competitive landscape for NDC 00310-0280 (Flibanserin) is currently characterized by a significant lack of direct competition for its approved indication.

Direct Competition:

• Absence of Approved Pharmacologic Competitors: As of late 2023, Flibanserin (Addyi) is the sole FDA-approved medication for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This means there are no other prescription drugs with the same indication that directly vie for the same patient population.

Indirect Competition and Alternative Treatments:

While direct pharmacologic competitors are absent, Flibanserin faces indirect competition and alternative approaches that patients and physicians consider:

• Non-Pharmacologic Therapies:
  • Psychotherapy and Sex Therapy: Cognitive Behavioral Therapy (CBT), couples counseling, and sex therapy are widely used to address psychological and relational factors contributing to HSDD. These therapies do not carry the side effect profile or cost associated with prescription drugs.
  • Behavioral Interventions: Lifestyle changes, stress management, and open communication within relationships are often recommended.
• Off-Label Use of Other Medications (Not Approved for HSDD):
  • Hormone Replacement Therapy (HRT): In some cases, particularly if hormonal imbalances are suspected (e.g., low testosterone in women), physicians may consider off-label use of testosterone or estrogen, though evidence for HSDD in premenopausal women is limited and off-label.
  • Antidepressants: Some antidepressants (e.g., bupropion) have been explored for potential benefits in sexual desire, but their efficacy specifically for HSDD is not established, and they can sometimes worsen sexual side effects.
• Investigational Therapies and Future Potential:
  • Other Drug Candidates: Pharmaceutical companies may have investigational compounds in early-stage development for various forms of female sexual dysfunction. However, these are typically years away from potential approval and would need to demonstrate clear advantages in efficacy, safety, or administration to challenge Flibanserin.
  • New Delivery Methods or Formulations: Future developments could involve novel delivery mechanisms or formulations of existing compounds, or entirely new molecular entities.
  • Non-Drug Therapeutic Devices: While less common for HSDD, the broader field of sexual health innovation may yield non-drug devices.

Competitive Positioning of Flibanserin (Addyi):

• First-Mover Advantage: Addyi benefits from being the first approved drug for this specific condition, establishing brand recognition and a clinical track record.
• Targeted Indication: Its strict indication limits its competitive set. If the market expands to include other types of sexual dysfunction, the competitive landscape would broaden.
• REMS Program: The REMS program acts as a barrier to entry for potential competitors and also shapes its competitive interaction by requiring a specific prescribing and dispensing pathway.
• Brand vs. Generic: As a branded product, it commands a higher price. A generic version, if and when it becomes available (typically after patent expiry), would significantly alter the pricing and competitive dynamics.

Patent Landscape:

The patent protection for Flibanserin is a critical factor in its current competitive advantage. The drug's primary patents and market exclusivity are expected to expire in the mid-to-late 2020s [5]. Upon patent expiry, the landscape will shift dramatically with the potential introduction of generic versions, leading to price erosion and increased competition. Therefore, the current competitive landscape is defined by its period of patent exclusivity.

In summary, the competitive landscape for NDC 00310-0280 is characterized by a clear, albeit temporary, lack of direct pharmacologic competition. Its primary challenges come from indirect alternatives, the complexity of its REMS program, and the eventual threat of generic entry upon patent expiry.

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Key Takeaways

• Nocd 00310-0280 (Flibanserin/Addyi) is the sole FDA-approved pharmacologic treatment for acquired, generalized HSDD in premenopausal women. This grants it a near-monopoly in a niche market.
• The current market size is estimated to be in the low to mid-hundreds of millions of US dollars annually, with projections indicating moderate to strong growth (10-25% CAGR) over the next 5-7 years. Growth is driven by increased diagnosis, improved payer coverage, and market education.
• Key market drivers include a significant unmet need, first-mover advantage, and growing awareness. Restraints are centered on a narrow indication, a stringent REMS program, a specific side effect profile (especially alcohol interaction), and patient adherence challenges.
• Current pricing for a 30-day supply ranges from $375-$425 USD (list price), with net prices considerably lower after discounts. The projected price trajectory is stable to slightly increasing, with potential for downward pressure in the mid-term if competition emerges or if value-based pricing becomes more dominant.
• The competitive landscape is currently defined by the absence of direct pharmacologic competitors. Indirect competition comes from psychotherapy, sex therapy, and off-label use of other medications. Patent expiry in the mid-to-late 2020s will introduce generic competition.

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Frequently Asked Questions

1. What are the primary side effects associated with Nocd 00310-0280 that impact its market adoption? The primary side effects of concern include dizziness, somnolence, nausea, and fatigue. A critical safety warning relates to the risk of severe hypotension and syncope, particularly when alcohol is consumed concurrently, which significantly impacts prescribing patterns and patient compliance.

2. How does the Risk Evaluation and Mitigation Strategy (REMS) for Flibanserin influence its market penetration? The REMS program mandates that healthcare providers must be specially certified to prescribe Flibanserin, and patients must acknowledge the drug's risks. This adds a layer of administrative complexity and can deter some prescribers and patients, thereby limiting broader market penetration.

3. What is the expected timeline for patent expiry of Flibanserin and the potential impact of generic entry? The primary patents for Flibanserin are anticipated to expire in the mid-to-late 2020s. Upon patent expiry, the introduction of generic versions is expected to lead to significant price erosion and increased market competition as multiple manufacturers enter the market.

4. Beyond pharmacologic treatments, what are the main alternative approaches for managing HSDD that compete with Nocd 00310-0280? Alternative approaches include psychotherapy, such as Cognitive Behavioral Therapy (CBT), couples counseling, and sex therapy, which address psychological and relational aspects of HSDD. Behavioral interventions like lifestyle changes and stress management are also commonly recommended.

5. What factors are most critical for sustained market growth of Flibanserin over the next five years? Sustained market growth for Flibanserin hinges on increasing diagnosis rates of HSDD, continued expansion of payer coverage and favorable reimbursement policies, effective ongoing patient and physician education initiatives, and maintaining a favorable safety profile without the emergence of significant new adverse event data.

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Citations

[1] Dennerstein, L., & Griffin, T. (2006). The epidemiology of sexual dysfunction in women. In Sexual Medicine (pp. 1-13). Blackwell Publishing Ltd.

[2] U.S. Food and Drug Administration. (2015, August 18). FDA approves Addyi (flibanserin) for the treatment of premenopausal women with acquired generalized hypoactive sexual desire disorder. Press Release.

[3] U.S. Food and Drug Administration. (n.d.). Addyi (flibanserin) REMS. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/addyi-flibanserin-rems

[4] Pollack, A. (2015, August 18). F.D.A. Approves First Drug to Treat Low Sexual Desire in Women. The New York Times. https://www.nytimes.com/2015/08/19/health/fda-approves-first-drug-to-treat-low-sexual-desire-in-women.html

[5] Data from patent databases and pharmaceutical industry analysis reports indicate expected patent expiry in the mid-to-late 2020s. Specific patent numbers and expiry dates are subject to ongoing legal challenges and extensions.