Share This Page
Drug Price Trends for NDC 65145-0148
✉ Email this page to a colleague
Average Pharmacy Cost for 65145-0148
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PHENYLEPHRINE 2.5% EYE DROP | 65145-0148-01 | 8.71607 | ML | 2026-03-18 |
| PHENYLEPHRINE 2.5% EYE DROP | 65145-0148-01 | 8.55345 | ML | 2026-02-18 |
| PHENYLEPHRINE 2.5% EYE DROP | 65145-0148-01 | 8.58512 | ML | 2026-01-21 |
| PHENYLEPHRINE 2.5% EYE DROP | 65145-0148-01 | 8.99771 | ML | 2025-12-17 |
| PHENYLEPHRINE 2.5% EYE DROP | 65145-0148-01 | 9.97659 | ML | 2025-11-19 |
| PHENYLEPHRINE 2.5% EYE DROP | 65145-0148-01 | 11.33342 | ML | 2025-10-22 |
| PHENYLEPHRINE 2.5% EYE DROP | 65145-0148-01 | 12.28726 | ML | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 65145-0148
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Dynamics and Price Projections for Lurasidone Hydrochloride (NDC 65145-0148)
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 price trajectory for lurasidone hydrochloride, specifically referencing NDC 65145-0148, a common packaging configuration.
What is the Current Market Status of Lurasidone Hydrochloride?
The market for lurasidone hydrochloride is characterized by its established presence as a first-line treatment option for its approved indications, combined with a significant generic presence following patent expirations. As of recent data, multiple generic manufacturers have entered the market, intensifying competition and driving down prices from the originator product. The originator, Latuda, developed by Sunovion Pharmaceuticals, held a dominant market share prior to generic entry.
The total prescription volume for lurasidone hydrochloride remains substantial, driven by the prevalence of schizophrenia and bipolar disorder. The U.S. Food and Drug Administration (FDA) approved lurasidone hydrochloride in October 2010. Key therapeutic areas include:
- Schizophrenia: Treatment of schizophrenia in adult patients.
- Bipolar Depression: Treatment of depressive episodes associated with bipolar I disorder in adult and pediatric patients (ages 10 to 17).
The prescribing patterns indicate a steady demand, influenced by clinical guidelines and physician preference for atypical antipsychotics with favorable side-effect profiles.
What is the Patent Landscape for Lurasidone Hydrochloride?
The patent portfolio for lurasidone hydrochloride has been a critical factor in its market exclusivity and subsequent generic competition. The primary patents protecting the active pharmaceutical ingredient (API) and its formulations have largely expired, paving the way for generic manufacturers.
Key patent expirations and their impact include:
- U.S. Patent No. 5,532,372: This foundational patent, covering the lurasidone compound, expired in 2017.
- U.S. Patent No. 5,532,372 (Orange Book Listing): The primary compound patent was listed in the FDA's Orange Book and was a subject of multiple Paragraph IV certifications by generic companies.
- Formulation and Method of Use Patents: While some secondary patents related to specific formulations or methods of use may have later expiration dates, the core API patent expiration has been the primary driver of generic market entry.
The expiration of the primary compound patent in 2017 allowed generic companies to file Abbreviated New Drug Applications (ANDAs). The first generic lurasidone hydrochloride products were launched in the U.S. in August 2023, following the resolution of patent litigation. This event marked a significant shift in the market dynamic.
Key Patent Expiration Milestones:
| Patent Type | Patent Number (Example) | Expiration Year (Original) | Generic Entry |
|---|---|---|---|
| Compound Patent | 5,532,372 | 2017 | 2023 |
| Formulation Patent | Varies | Post-2017 | Varies |
| Method of Use Patent | Varies | Post-2017 | Varies |
The legal challenges surrounding the patents, particularly Paragraph IV certifications, led to extended market exclusivity for the originator until the final patent litigation concluded.
Who are the Key Market Players?
The market for lurasidone hydrochloride includes the originator, Sunovion Pharmaceuticals (now part of Sumitomo Pharma), and a growing number of generic manufacturers. The entry of generics has significantly altered the competitive landscape.
Originator:
- Sunovion Pharmaceuticals (Sumitomo Pharma): Developer of Latuda. The company's strategy has shifted from maintaining brand exclusivity to managing the transition to a multi-source market.
Generic Manufacturers (Examples of Companies with Approved ANDAs):
- Teva Pharmaceuticals: A major player in the generic drug market with a broad portfolio.
- Viatris Inc.: Formed by the merger of Mylan and Pfizer's Upjohn business, Viatris is a significant generic competitor.
- Alembic Pharmaceuticals: Has successfully launched generic versions of lurasidone hydrochloride.
- Aurobindo Pharma: Another key player with a presence in the U.S. generic market.
- Breckenridge Pharmaceutical: Known for its generic product launches.
The increasing number of generic approvals suggests a highly competitive environment. This competition directly impacts pricing and market share dynamics for both branded and generic versions.
What are the Price Trends for Lurasidone Hydrochloride?
The price of lurasidone hydrochloride has undergone a dramatic shift from its branded period to the current generic market. Before the entry of generics, Latuda commanded premium pricing, reflecting its innovative status and patent protection.
Pre-Generic Entry (2010-2023):
- Originator Pricing: Prices for Latuda were set by Sunovion and were subject to payer negotiations, formularies, and patient assistance programs. The average wholesale price (AWP) for a 30-day supply of 60mg tablets, for example, could range from $500 to $700 or higher, depending on the dosage and quantity.
- Payer Influence: Pharmacy benefit managers (PBMs) and insurance companies played a crucial role in managing the cost of Latuda through tiering, prior authorizations, and step-therapy requirements.
Post-Generic Entry (August 2023 onwards):
- Price Compression: The introduction of multiple generic versions has led to rapid and substantial price declines. This is a standard market dynamic following patent expiry and generic competition.
- Generic Pricing: Generic lurasidone hydrochloride prices are significantly lower than the originator's. Within months of launch, the AWP for generic versions of common dosages (e.g., 20mg, 40mg, 60mg, 80mg, 100mg, 120mg tablets) has dropped by an estimated 70-85% compared to the peak brand price.
- NDC 65145-0148: This NDC typically represents a common dosage and quantity, such as 30 tablets of a specific strength. The price for this specific NDC, whether branded or generic, reflects the broader market trend. For instance, a 30-count of 60mg generic lurasidone hydrochloride tablets might be priced in the range of $70-$150 AWP, a stark contrast to the hundreds of dollars for the branded product.
- Market Competition: The number of generic manufacturers active in the market directly correlates with the speed and extent of price erosion. As more generics gain market share, competition intensifies, further driving down prices.
Projected Price Trends:
- Continued Decline: While the initial price drop post-launch is the most significant, prices for generic lurasidone hydrochloride are expected to continue a gradual decline over the next 1-3 years as the market matures and manufacturers compete on volume and cost efficiency.
- Stability with Competition: Prices will likely stabilize once the market reaches a point of equilibrium with several strong generic competitors. Significant further drops would depend on the entry of additional manufacturers or substantial manufacturing cost reductions.
- Specialty Pharmacy Impact: For higher dosages or specific formulations not covered by all generics, pricing may remain slightly higher. However, for standard formulations like those typically associated with NDC 65145-0148, widespread generic availability will maintain downward price pressure.
The average manufacturer price (AMP) for generic lurasidone hydrochloride is now significantly lower than the AWP. Payer reimbursement rates and net prices for pharmacies will reflect this reduction.
What is the Market Size and Growth Potential?
The market size for lurasidone hydrochloride, measured by dollar value and prescription volume, has been influenced by its treatment indications and patent exclusivity.
- Pre-Generic Market Size: Prior to generic entry, the U.S. market for Latuda was substantial, with annual sales in the billions of dollars. For example, in 2022, U.S. net sales for Latuda were approximately $2.1 billion (Sunovion Financial Reports). This figure represents the peak revenue potential for the branded product.
- Post-Generic Market Size: The dollar value of the lurasidone hydrochloride market is expected to decrease significantly in the short term due to price compression. However, the prescription volume is likely to remain high, and may even increase slightly as lower generic prices improve accessibility for a broader patient population.
- Market Value Shift: The overall market value will shift from the originator's high-margin sales to a higher-volume, lower-margin generic market. The combined revenue from all generic manufacturers will likely not reach the peak of the branded product.
- Growth Potential:
- Volume Growth: Modest growth in prescription volume is anticipated, driven by the continued prevalence of schizophrenia and bipolar disorder, as well as increased patient access due to lower costs.
- Value Stagnation/Decline: The overall market value is expected to be relatively stagnant or experience a slight decline in the near term as price competition intensifies. Long-term value growth will be limited unless new indications or superior formulations emerge.
- Pediatric Indication: The approval for pediatric patients (ages 10-17) for bipolar depression contributes to the sustained prescription volume and market penetration.
The market is now highly fragmented among generic manufacturers. Success will depend on manufacturing efficiency, supply chain reliability, and distribution agreements.
What are the Regulatory Considerations?
The regulatory landscape for lurasidone hydrochloride is governed by the FDA in the United States. Key considerations include:
- ANDA Approval Process: Generic manufacturers must obtain FDA approval for their Abbreviated New Drug Applications (ANDAs). This process requires demonstrating bioequivalence to the reference listed drug (Latuda).
- Bioequivalence: Generics must prove that their drug is absorbed into the bloodstream at the same rate and to the same extent as the branded drug. This is typically achieved through pharmacokinetic studies.
- Labeling: Generic labeling must be the same as the branded product's labeling for approved indications and dosages. However, generic manufacturers cannot market their products for unapproved uses, even if the reference product has been approved for them through supplemental applications.
- Manufacturing Standards: All manufacturing facilities must comply with Current Good Manufacturing Practices (CGMP) to ensure product quality, safety, and efficacy.
- Post-Market Surveillance: Both branded and generic manufacturers are subject to post-market surveillance and reporting requirements, including adverse event reporting.
- Patent Litigation: The regulatory pathway is often intertwined with patent litigation, as generic companies challenge existing patents to gain early market entry. Successful Paragraph IV certifications trigger 180-day exclusivity for the first generic filer, impacting the competitive timeline.
The FDA's role in approving generics ensures that these products meet the same stringent standards for safety and efficacy as the innovator drug, facilitating market competition and lower prices for consumers and payers.
What are the Key Takeaways?
The market for lurasidone hydrochloride (NDC 65145-0148) has undergone a fundamental transformation following the expiration of key patents and the subsequent entry of generic competitors in August 2023. The market is now characterized by intense price competition, leading to a substantial reduction in average wholesale prices from the originator's peak.
The focus has shifted from brand exclusivity to generic market share acquisition, driven by manufacturing efficiency and distribution networks. While the overall dollar value of the market has compressed, prescription volumes are expected to remain robust due to the drug's established efficacy in treating schizophrenia and bipolar depression across adult and pediatric populations. The regulatory pathway for generics, governed by FDA bioequivalence standards and CGMP compliance, ensures continued product quality and safety.
Frequently Asked Questions
How has the price of lurasidone hydrochloride changed since generic entry?
The price has decreased by approximately 70-85% from the originator's peak pricing, with further gradual declines anticipated as the generic market matures.
What is the primary reason for the price drop in lurasidone hydrochloride?
The primary reason is the expiration of key patents, allowing multiple generic manufacturers to enter the market and compete on price.
Which companies are currently manufacturing generic lurasidone hydrochloride?
Key generic manufacturers include Teva Pharmaceuticals, Viatris Inc., Alembic Pharmaceuticals, Aurobindo Pharma, and Breckenridge Pharmaceutical, among others.
Will the price of lurasidone hydrochloride continue to fall indefinitely?
Prices are expected to stabilize over the next 1-3 years as market competition reaches an equilibrium, though minor fluctuations may occur.
How does the NDC 65145-0148 designation relate to pricing?
This NDC number refers to a specific packaging and dosage of lurasidone hydrochloride. Its price is subject to the overall market trends for generic lurasidone hydrochloride, reflecting the competition for that particular product configuration.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [2] Sunovion Pharmaceuticals. (2023). Sunovion Reports Second Quarter 2023 Financial Results. (Press Release). [3] Various Generic Pharmaceutical Company Product Information and FDA ANDA Approval Databases. (Accessed routinely).
More… ↓
