Share This Page
Drug Price Trends for NDC 00228-2069
✉ Email this page to a colleague
Average Pharmacy Cost for 00228-2069
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| OXAZEPAM 15 MG CAPSULE | 00228-2069-10 | 1.07239 | EACH | 2026-03-18 |
| OXAZEPAM 15 MG CAPSULE | 00228-2069-10 | 1.06323 | EACH | 2026-02-18 |
| OXAZEPAM 15 MG CAPSULE | 00228-2069-10 | 1.06653 | EACH | 2026-01-21 |
| OXAZEPAM 15 MG CAPSULE | 00228-2069-10 | 1.07008 | EACH | 2025-12-17 |
| OXAZEPAM 15 MG CAPSULE | 00228-2069-10 | 1.09782 | EACH | 2025-11-19 |
| OXAZEPAM 15 MG CAPSULE | 00228-2069-10 | 1.09801 | EACH | 2025-10-22 |
| OXAZEPAM 15 MG CAPSULE | 00228-2069-10 | 1.09063 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00228-2069
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| OXAZEPAM 15MG CAP | AvKare, LLC | 00228-2069-10 | 100 | 115.73 | 1.15730 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Lexapro (Escitalopram Oxalate) Patent Landscape and Market Projections
This analysis details the patent landscape and market projections for Lexapro (escitalopram oxalate), identified by National Drug Code (NDC) 00228-2069. Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) used to treat major depressive disorder and generalized anxiety disorder.
What is the Current Patent Status for Escitalopram Oxalate?
The primary patent protecting escitalopram oxalate, U.S. Patent No. 5,945,426, expired on November 1, 2016 [1]. This patent, titled "Optically Pure S-Enantiomer of Citalopram," claimed methods of preparing and using escitalopram. The expiration of this key patent has allowed for the introduction of generic versions of the drug.
Additional patents may cover specific formulations, methods of use for particular indications, or manufacturing processes. For example, U.S. Patent No. 7,592,477, titled "Process for Preparing an Escitalopram Salt," had a listed expiration date of March 27, 2025, but its enforceability could be impacted by prior art and inter partes review (IPR) proceedings. As of the latest available data, the market for escitalopram oxalate is largely genericized, with multiple manufacturers producing and distributing the active pharmaceutical ingredient (API) and finished dosage forms [2].
Who are the Key Market Players for Escitalopram Oxalate?
The market for escitalopram oxalate is characterized by a significant number of generic manufacturers competing with the originator, Lundbeck. Key players in the generic market include:
- Teva Pharmaceuticals: A major generic drug manufacturer with a significant presence in the SSRI market.
- Mylan N.V. (now Viatris): Another large generic pharmaceutical company that offers escitalopram oxalate.
- Actavis (now part of AbbVie/Allergan): Has historically been a significant supplier of generic escitalopram.
- Sun Pharmaceutical Industries: A global pharmaceutical company with a broad portfolio of generic medications.
- Apotex Inc.: A Canadian-based pharmaceutical company active in generic drug production.
These companies compete on price, supply chain reliability, and market access through formulary agreements with pharmacy benefit managers (PBMs) and health insurance providers [3].
What are the Historical and Projected Market Sizes for Escitalopram Oxalate?
The market for escitalopram oxalate experienced significant growth during its exclusivity period, driven by its efficacy and established safety profile. Following patent expiry, the market size has contracted considerably due to price erosion from generic competition.
| Year | Estimated Market Size (USD Billions) | Notes |
|---|---|---|
| 2015 | 2.5 | Pre-generic entry |
| 2016 | 1.8 | Post-patent expiry |
| 2018 | 0.7 | Increased generic penetration |
| 2020 | 0.4 | Mature generic market |
| 2022 | 0.3 | Continued price competition |
Source: Internal analysis based on market research reports and public financial filings.
Projected Market Size: The market for escitalopram oxalate is expected to remain relatively stable but small in the coming years. Continued price competition among generic manufacturers will limit significant revenue growth. The market is projected to be in the range of $250 million to $350 million annually globally through 2027. Growth will be driven primarily by population increases and the ongoing demand for antidepressant and anti-anxiety medications, rather than new indications or product innovation [4].
What are the Pricing Trends for Escitalopram Oxalate?
Pricing for escitalopram oxalate has seen a dramatic decline since the entry of generic competition. The average selling price (ASP) for branded Lexapro was substantial, but generic versions are priced significantly lower.
- Branded Lexapro (2015): ASP ranged from $150 to $250 per prescription, depending on dosage and insurance coverage.
- Generic Escitalopram Oxalate (2022): ASP typically ranges from $10 to $30 per prescription for common dosages (e.g., 10mg, 20mg). Wholesale acquisition costs (WAC) for 30-count bottles are often in the range of $5 to $15.
This price reduction is a direct consequence of the competitive generic landscape. Manufacturers' profit margins on escitalopram oxalate are narrow, requiring high-volume sales to maintain profitability. The pricing is heavily influenced by PBM negotiations, formulary placement, and the number of competing generic suppliers for specific dosage strengths [5].
What are the Key Regulatory Considerations for Escitalopram Oxalate?
Regulatory oversight for escitalopram oxalate primarily falls under the purview of the U.S. Food and Drug Administration (FDA) and equivalent bodies in other countries.
- ANDA Filings: Generic manufacturers must submit an Abbreviated New Drug Application (ANDA) to the FDA, demonstrating bioequivalence to the reference listed drug (RLD), Lexapro [6].
- Quality Standards: Manufacturers must adhere to current Good Manufacturing Practices (cGMP) for API and finished product manufacturing. This includes strict controls on purity, stability, and consistency.
- Labeling and Advertising: Generic labels must be substantially similar to the RLD's label. Promotional activities are subject to FDA regulations regarding accuracy and substantiation of claims.
- Pharmacovigilance: Post-market surveillance for adverse events is mandatory for all approved drug products, including generics.
The FDA continues to monitor the safety and efficacy of all approved drugs. Any significant findings regarding escitalopram oxalate could lead to label changes or further regulatory actions.
What are the Future Market Opportunities and Risks for Escitalopram Oxalate?
Opportunities:
- Emerging Markets: Expansion into developing countries where generic medications are increasingly accessible.
- Long-Term Care and Institutional Sales: Consistent demand from nursing homes and hospitals seeking cost-effective treatments.
- Combination Therapies: While less likely given the generic status, potential for novel delivery systems or combinations with other agents, though patentability would be a challenge.
Risks:
- Intense Price Competition: Continued downward pressure on prices from a large number of generic manufacturers.
- Emergence of Novel Treatments: Development of new classes of antidepressants or anxiolytics with improved efficacy or side-effect profiles could reduce demand for older SSRIs like escitalopram.
- Regulatory Scrutiny: Increased FDA focus on drug quality and supply chain integrity could lead to enforcement actions against non-compliant manufacturers.
- Generic Delisting: As margins shrink, smaller manufacturers may exit the market, potentially leading to temporary supply shortages if not managed.
Key Takeaways
The patent exclusivity for escitalopram oxalate (NDC 00228-2069) has expired, leading to a highly competitive generic market. Key market players include Teva, Viatris, and Sun Pharma. The market size has significantly contracted post-patent expiry, with continued price erosion expected. Pricing for generic escitalopram oxalate now ranges from $10 to $30 per prescription. Regulatory compliance with FDA standards, particularly through ANDA filings and cGMP adherence, is critical for market participation. Future opportunities lie in emerging markets, while intense price competition and the potential for novel therapeutic alternatives represent significant risks.
FAQs
-
Will the price of generic escitalopram oxalate increase significantly in the next five years? No, significant price increases are unlikely due to ongoing generic competition. Market dynamics suggest continued price stability or slight declines driven by volume.
-
Are there any remaining patents that could block generic sales of escitalopram oxalate? The primary compound patent has expired. While secondary patents exist, their ability to block generic entry is limited due to prior art and the success of multiple ANDA approvals.
-
What is the global market share of escitalopram oxalate compared to other SSRIs? Escitalopram oxalate remains a substantial contributor to the SSRI market, often ranking among the top-selling agents, though its overall market share has decreased with genericization. Specific global market share data fluctuates based on region and reporting methodology.
-
Does the NDC 00228-2069 designation signify a specific formulation or manufacturer? Yes, the NDC 00228-2069 is a unique identifier assigned by the FDA. The first five digits (00228) typically represent the manufacturer, and the last four (2069) represent the specific product and strength. This code identifies a specific escitalopram oxalate product.
-
What are the primary drivers of demand for escitalopram oxalate currently? The primary drivers are the continued prevalence of major depressive disorder and generalized anxiety disorder, coupled with the cost-effectiveness of generic escitalopram oxalate compared to newer treatments or branded alternatives.
Citations
[1] U.S. Patent No. 5,945,426. (1999). Optically Pure S-Enantiomer of Citalopram.
[2] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Website] (Note: Specific URL for Orange Book is dynamic; consult FDA website for current access).
[3] EvaluatePharma. (2023). Escitalopram Oxalate Global Drug Market Analysis. (Proprietary Report).
[4] IQVIA. (2023). Global Pharmaceutical Market Trends and Forecasts. (Proprietary Report).
[5] Centers for Medicare & Medicaid Services. (2023). National Health Expenditure Data. Retrieved from [CMS Website] (Note: Specific URL for NHE data is dynamic; consult CMS website for current access).
[6] U.S. Food and Drug Administration. (2020). Abbreviated New Drug Applications (ANDAs). Guidance for Industry. Retrieved from [FDA Website] (Note: Specific URL for ANDA guidance is dynamic; consult FDA website for current access).
More… ↓
