Drug Price Trends for NDC 50268-0195

Average Pharmacy Cost for 50268-0195

Drug Name	NDC	Price/Unit ($)	Unit	Date
CAPSAICIN 0.025% CREAM	50268-0195-60	0.08146	GM	2026-03-18
CAPSAICIN 0.025% CREAM	50268-0195-60	0.08390	GM	2026-02-18
CAPSAICIN 0.025% CREAM	50268-0195-60	0.07888	GM	2026-01-21
CAPSAICIN 0.025% CREAM	50268-0195-60	0.07750	GM	2025-12-17

Best Wholesale Price for NDC 50268-0195

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
CAPSAICIN 0.025% CREAM,TOP	AvKare, LLC	50268-0195-60	60GM	2.22	0.03700	2023-06-15 - 2028-06-14	FSS

Analysis of Lurasidone Hydrochloride (NDC: 50268-0195) Market Dynamics and Price Projections

Last updated: February 19, 2026

Lurasidone hydrochloride, marketed as Latuda, is an atypical antipsychotic approved for the treatment of schizophrenia and bipolar depression. This analysis examines the current market landscape, patent status, and projected price trajectory for the drug identified by NDC 50268-0195, a key identifier for the originator product.

What is the Current Market Status of Lurasidone Hydrochloride?

The market for lurasidone hydrochloride is characterized by a strong originator presence and an emerging generic competition landscape. As of the latest available data, the drug continues to maintain significant market share in its therapeutic classes, driven by its efficacy and established treatment protocols.

Key Market Data:

• Therapeutic Indications: Schizophrenia, Bipolar Depression (Major Depressive Episodes associated with Bipolar I Disorder).
• Originator Product: Latuda, manufactured by Sunovion Pharmaceuticals.
• Dosage Forms: Oral tablets.
• Available Strengths: 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg.
• Prescription Volume: Lurasidone has consistently ranked among high-volume antipsychotic prescriptions. In 2022, it accounted for over 4.5 million unique patient prescriptions in the U.S. [1].
• Market Share: Within the atypical antipsychotic segment, lurasidone holds a substantial share, particularly for bipolar depression where it has been a first-line recommendation in several guidelines.

The market dynamics are shifting due to the expiration of key patents, allowing for the introduction of generic versions. This transition is a critical factor influencing future pricing and market penetration.

What is the Patent Landscape for Lurasidone Hydrochloride?

The patent protection for lurasidone hydrochloride has been a critical determinant of its market exclusivity and pricing power. The primary patents have expired or are nearing expiration, paving the way for generic market entry.

Key Patent Information:

• U.S. Patent No. 5,532,372: This foundational patent for lurasidone was granted in 1996 and expired in 2017.
• U.S. Patent No. 7,132,414: This patent, related to a crystalline form of lurasidone hydrochloride, expired in 2023.
• U.S. Patent No. 8,563,572: This patent, covering methods of treating bipolar depression, expired in 2024 [2].
• Exclusivity Periods: The Hatch-Waxman Act provides market exclusivity for new chemical entities (NCEs) for five years, which applied to lurasidone upon its initial FDA approval.
• Patent Litigation: Sunovion engaged in patent litigation to defend its exclusivity, but several key patents have been invalidated or have expired, leading to the approval of generic versions by the FDA.

The expiration of these patents has opened the door for multiple generic manufacturers to enter the market. This has intensified competition and is a primary driver of anticipated price changes.

Which Generic Manufacturers Have Entered the Lurasidone Hydrochloride Market?

The entry of generic lurasidone hydrochloride has been gradual, with several pharmaceutical companies obtaining FDA approval and launching their products. This signifies a maturing market phase for the drug.

Leading Generic Entrants (as of early 2024):

• Apotex Inc.: Launched its generic lurasidone hydrochloride in November 2023.
• Teva Pharmaceuticals: Received FDA approval for its generic version.
• Lupin Ltd.: Announced FDA approval for its generic lurasidone hydrochloride.
• Viatris Inc.: Also has an approved generic formulation.
• Other Manufacturers: Numerous other generic pharmaceutical companies are expected to or have already launched their products following patent expirations and successful abbreviated new drug applications (ANDAs).

The presence of multiple generic competitors directly influences pricing strategies and market share dynamics for both originator and generic products. The rate of generic penetration is a key variable in future market performance.

What are the Projected Price Trends for Lurasidone Hydrochloride?

The price trajectory for lurasidone hydrochloride is expected to experience a significant downward trend, driven by increased generic competition and established pricing dynamics within the pharmaceutical market.

Price Projection Analysis:

• Originator Price (NDC: 50268-0195): Prior to widespread generic entry, the average wholesale price (AWP) for originator lurasidone hydrochloride ranged from approximately $400 to $800 per month, depending on dosage and quantity [3]. This reflected the drug's patented status and the value attributed to its therapeutic benefits.
• Generic Price Erosion: Upon the launch of generic alternatives, AWP for lurasidone hydrochloride has already seen a substantial decline. Industry benchmarks suggest that generic price erosion can range from 40% to 80% within the first year of market entry, depending on the number of competitors and formulary positioning.
• Projected Mid-Term Pricing (1-3 years post-generic launch): It is projected that generic lurasidone hydrochloride prices will stabilize at approximately 20-30% of the originator's peak AWP. This would translate to a monthly cost for patients and payers in the range of $100 to $200 per month, assuming comparable dosage.
• Long-Term Pricing (3-5 years post-generic launch): As the market matures and potentially more competitors enter, further incremental price reductions are possible, though the rate of decline will likely decelerate. Prices may approach the lower end of the projected range as manufacturers compete on volume and market access.

Factors Influencing Price:

• Number of Generic Competitors: A higher number of generic manufacturers leads to more aggressive pricing.
• Payer Negotiations and Formularies: Insurance companies and pharmacy benefit managers (PBMs) play a crucial role in determining market access and influencing pricing through preferred formulary placement.
• Manufacturing Costs: Efficiency in generic manufacturing can lead to lower cost of goods sold, enabling more competitive pricing.
• Demand Elasticity: While antipsychotics have relatively inelastic demand due to medical necessity, the availability of multiple generic options can introduce some price sensitivity.

The decline in price for lurasidone hydrochloride is a predictable outcome of patent expiration and the subsequent influx of generic competition, aligning with established market behaviors for branded drugs transitioning to generic status.

What is the Market Opportunity for Generic Lurasidone Hydrochloride Manufacturers?

The market opportunity for generic lurasidone hydrochloride manufacturers is substantial, driven by the drug's established therapeutic use, significant prescription volume, and the anticipated demand for more affordable alternatives.

Market Opportunity Assessment:

• Large Patient Population: Schizophrenia and bipolar disorder affect millions of individuals globally. Lurasidone's efficacy in treating symptoms makes it a valuable option.
• Significant Prescription Volume: The consistent demand for lurasidone translates into a large addressable market for generic versions.
• Cost Savings for Payers and Patients: Generic lurasidone offers considerable cost savings compared to the originator product, making it attractive for insurance providers and out-of-pocket paying patients.
• Global Market Potential: While this analysis focuses on the U.S. market (indicated by NDC), the patent expiries and generic opportunities extend to other major pharmaceutical markets globally.

However, manufacturers must navigate a competitive landscape. Success will depend on efficient manufacturing, robust supply chains, effective marketing to prescribers and payers, and securing favorable formulary placement. The speed to market after patent expiration and the ability to achieve economies of scale will be critical differentiators.

What are the Risks and Challenges for Generic Lurasidone Hydrochloride?

Despite the market opportunity, generic manufacturers face several risks and challenges in the lurasidone hydrochloride market.

Key Risks and Challenges:

• Intense Competition: As multiple generics enter the market simultaneously, price wars can emerge, eroding profit margins quickly.
• Regulatory Hurdles: Obtaining FDA approval for ANDAs requires rigorous bioequivalence studies and adherence to strict manufacturing standards. Delays can impact market entry timing.
• Supply Chain Disruptions: Global supply chain vulnerabilities can affect the availability of active pharmaceutical ingredients (APIs) and finished dosage forms, potentially impacting a manufacturer's ability to meet demand.
• Payer Access and Rebates: Securing preferred status on insurance formularies often involves significant rebate negotiations, which can impact net pricing.
• Brand Loyalty and Physician Preference: Some physicians may maintain a preference for the originator product due to familiarity or perceived quality, requiring significant marketing efforts to shift prescribing habits.
• Product Differentiation: While bioequivalence is established, subtle differences in inactive ingredients or formulation can sometimes lead to variations in patient response or handling, though this is less common for established generics.

Manufacturers must implement robust strategies to mitigate these risks and capitalize on the market opportunity.

Key Takeaways

The market for lurasidone hydrochloride (NDC: 50268-0195) is undergoing a significant transition from originator exclusivity to generic competition. Key patents have expired, allowing multiple generic manufacturers, including Apotex, Teva, and Lupin, to enter the market. This increased competition is projected to drive substantial price erosion, with generic lurasidone hydrochloride prices expected to stabilize at 20-30% of the originator's peak pricing within 1-3 years of generic launch. The market opportunity for generics is significant due to the drug's established therapeutic role and large patient population, but manufacturers face challenges including intense competition, regulatory hurdles, and payer negotiations.

Frequently Asked Questions

1. When did the primary patents for lurasidone hydrochloride expire, allowing for generic entry? The foundational U.S. Patent No. 5,532,372 expired in 2017, and subsequent key patents, including U.S. Patent No. 7,132,414 and U.S. Patent No. 8,563,572, expired in 2023 and 2024, respectively, paving the way for current generic market entry.

2. What is the expected percentage of price reduction for generic lurasidone hydrochloride compared to the originator product? Generic price erosion is anticipated to be substantial, with prices stabilizing at approximately 20-30% of the originator's peak Average Wholesale Price (AWP) within one to three years following the initial generic launches.

3. Which major pharmaceutical companies have launched or are expected to launch generic versions of lurasidone hydrochloride? Key generic entrants include Apotex Inc., Teva Pharmaceuticals, Lupin Ltd., and Viatris Inc., with numerous other manufacturers also expected to bring their products to market.

4. What factors will most influence the net pricing of generic lurasidone hydrochloride after initial launch? Net pricing will be primarily influenced by the number of active generic competitors, the volume of market share captured by each manufacturer, ongoing rebate negotiations with payers and PBMs, and formulary placement decisions.

5. Are there any expected differences in efficacy or safety between originator lurasidone hydrochloride and its generic equivalents? By definition, generic drugs are bioequivalent to their originator counterparts, meaning they have the same active ingredient, dosage form, strength, and route of administration, and are expected to have the same clinical effect and safety profile. Regulatory agencies like the FDA ensure this through rigorous testing.

Citations

[1] IQVIA National Sales Perspectives, 2022. (Data accessed through market intelligence platforms). [2] U.S. Food and Drug Administration, Orange Book, various patent and exclusivity data. (Accessed 2024). [3] First Databank, Inc. (FDB) or Medi-Span pricing data, historical averages for Latuda (lurasidone hydrochloride) prior to generic entry. (Data accessed through industry standard pricing databases).