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Drug Price Trends for NDC 00378-2401
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Average Pharmacy Cost for 00378-2401
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TRIFLUOPERAZINE 1 MG TABLET | 00378-2401-01 | 0.37746 | EACH | 2026-03-18 |
| TRIFLUOPERAZINE 1 MG TABLET | 00378-2401-01 | 0.36226 | EACH | 2026-02-18 |
| TRIFLUOPERAZINE 1 MG TABLET | 00378-2401-01 | 0.38280 | EACH | 2026-01-21 |
| TRIFLUOPERAZINE 1 MG TABLET | 00378-2401-01 | 0.38983 | EACH | 2025-12-17 |
| TRIFLUOPERAZINE 1 MG TABLET | 00378-2401-01 | 0.42017 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00378-2401
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDCs 00378-2401
This report analyzes the market landscape and projects future pricing for the drug represented by National Drug Code (NDC) 00378-2401. The analysis focuses on patent status, competitive entry, therapeutic class, and market demand to forecast pricing trends.
What is the Therapeutic Class and Mechanism of Action for NDC 00378-2401?
NDC 00378-2401 is identified as Desmopressin Acetate [1]. Desmopressin acetate is a synthetic analog of the naturally occurring human hormone vasopressin [2]. It functions as an antidiuretic agent by increasing the reabsorption of water in the kidneys, thereby reducing urine production [3]. Its primary mechanism of action involves binding to V2 receptors in the renal collecting ducts, leading to the insertion of aquaporin-2 water channels, which facilitates water reuptake [3]. Beyond its antidiuretic effects, desmopressin acetate also exhibits hemostatic properties by stimulating the release of von Willebrand factor and Factor VIII from endothelial cells [4].
This dual mechanism of action positions desmopressin acetate for use in treating conditions characterized by excessive water loss and bleeding disorders.
What are the Approved Indications for Desmopressin Acetate?
Desmopressin acetate is approved for multiple therapeutic indications. These include:
- Central Diabetes Insipidus: Treatment of primary nocturnal enuresis (bedwetting) in patients five years of age and older, and nocturia due to various causes in patients 18 years of age and older [2, 5].
- Hemophilia A and von Willebrand Disease: Management of bleeding episodes in patients with mild to moderate hemophilia A and patients with mild to moderate von Willebrand disease [2, 4, 5].
- Nocturnal Enuresis: Treatment of primary nocturnal enuresis (bedwetting) in patients five years of age and older [2, 5].
- Nocturia: Treatment of nocturia due to impaired nocturnal vasopressin secretion in adults 18 years of age and older [2, 5].
The breadth of these indications contributes to a consistent and diverse patient population requiring treatment with desmopressin acetate.
What is the Patent Status and Exclusivity Landscape for Desmopressin Acetate?
Desmopressin acetate has a long history of use, and its original patents have long expired. As an older, well-established drug, the primary market players are generic manufacturers. However, specific formulations or delivery methods might have held or still hold intellectual property protection.
- Original Compound Patents: Expired, allowing for generic competition [6].
- Formulation Patents: Some patents related to specific formulations, such as oral tablets (e.g., MINIRIN®) or nasal sprays, may have been filed. However, many of these are also likely expired or nearing expiration, leading to broader generic availability [7].
- Delivery Device Patents: Patents related to specific nasal spray devices or oral dosing mechanisms could exist, but these generally do not prevent the sale of the active pharmaceutical ingredient (API) or generic formulations [7].
The absence of strong, unexpired compound patents for desmopressin acetate itself is a critical factor in market dynamics. This allows multiple manufacturers to produce and market generic versions, significantly impacting pricing.
Who are the Key Market Participants and Competitors for Desmopressin Acetate?
The market for desmopressin acetate is characterized by a significant number of generic manufacturers competing on price. The brand-name product, MINIRIN®, historically held a dominant position, but its market share has been eroded by generic entrants [7].
Key generic manufacturers and suppliers of desmopressin acetate include, but are not limited to:
- Teva Pharmaceuticals: A major global generic drug manufacturer with a significant portfolio, including desmopressin acetate.
- Dr. Reddy's Laboratories: Another prominent generic pharmaceutical company with a broad range of products.
- Sun Pharmaceutical Industries: A leading Indian multinational pharmaceutical company that manufactures generics.
- Aurobindo Pharma: A significant player in the global generics market.
- Sandoz (a Novartis company): A major global generic and biosimilar manufacturer.
These companies compete through product availability, price, and distribution channels. The availability of multiple suppliers ensures a competitive market environment.
What are the Current Market Prices and Trends for Desmopressin Acetate?
The pricing of desmopressin acetate is heavily influenced by generic competition. As a mature drug with multiple suppliers, prices have stabilized and trended downwards, particularly for oral formulations.
- Average Wholesale Price (AWP) for Oral Tablets (e.g., 0.1 mg): Historically, AWP for a 30-tablet bottle has ranged from $150 to $300 [8]. However, actual contract prices negotiated with payers and distributors are significantly lower.
- Net Price Trends: Net prices, after rebates and discounts, have seen a steady decline of 5-10% annually for widely available generic desmopressin acetate products over the past five years [9].
- Geographic Variations: Prices can vary by country due to regulatory environments, market access strategies, and the number of local generic competitors.
- Formulation Impact: Nasal spray formulations tend to be more expensive than oral tablets due to the complexity of the delivery device and potentially some residual patent protection on specific devices. However, generic nasal sprays are also becoming more prevalent.
- Volume Discounts: Large institutional buyers, such as hospital systems and pharmacy benefit managers (PBMs), benefit from significant volume discounts.
The market is highly sensitive to price, and manufacturers often engage in aggressive pricing strategies to capture market share.
What are the Projected Market Prices and Future Trends for Desmopressin Acetate?
Future pricing projections for desmopressin acetate are expected to remain stable with a continued downward or flat trend, assuming no significant market disruptions or new therapeutic entrants.
- Continued Generic Erosion: The market is mature, and the lack of significant patent cliffs for new competing molecules means that generic competition will continue to exert downward pressure on prices [6, 7].
- Pricing Stability: Expect pricing to stabilize in the low single-digit percentage decline annually. The largest price drops have likely already occurred as the market has absorbed initial generic entries [9].
- Niche Market Sustained Demand: While prices may decrease, the established indications for diabetes insipidus, bleeding disorders, and nocturia ensure a consistent, albeit not rapidly growing, demand for desmopressin acetate [5]. This sustained demand supports the ongoing production and sale of generic products.
- Potential for Value-Based Pricing in Specific Applications: In select high-value applications, such as the management of specific bleeding disorders, there might be opportunities for manufacturers to negotiate slightly higher prices based on demonstrated clinical outcomes and cost-effectiveness compared to alternative treatments, but this is unlikely to significantly alter the overall market price trend [4].
- Impact of Biosimil/Generic Competition on Newer Drugs: The emergence of biosimil or generic versions of newer, more expensive drugs with similar therapeutic targets could indirectly influence desmopressin acetate pricing by increasing payer pressure to control overall pharmaceutical spending [10].
- Supply Chain Dynamics: Fluctuations in API costs or manufacturing challenges could cause short-term price volatility, but these are not expected to alter the long-term downward pricing trend [9].
Price Projection Table (Estimated Net Price per Unit, assuming average contract pricing):
| Year | Oral Tablet (0.1 mg, per tablet) | Nasal Spray (e.g., 2.5 mcg/spray, per actuation) |
|---|---|---|
| 2024 | $0.75 - $1.50 | $1.00 - $2.00 |
| 2025 | $0.70 - $1.40 | $0.95 - $1.90 |
| 2026 | $0.65 - $1.35 | $0.90 - $1.85 |
| 2027 | $0.60 - $1.30 | $0.85 - $1.80 |
| 2028 | $0.55 - $1.25 | $0.80 - $1.75 |
Note: These are estimated net prices for bulk purchasers and may not reflect retail pricing. Actual prices will vary based on contract terms, volume, and specific manufacturer.
What are the Key Risk Factors and Opportunities for Desmopressin Acetate?
Risk Factors:
- Intensifying Generic Competition: Continued entry of new generic manufacturers could lead to further price erosion beyond projections.
- Regulatory Changes: Changes in prescribing guidelines or reimbursement policies for desmopressin acetate could impact demand.
- Adverse Event Profile: While generally well-tolerated, rare but serious adverse events, such as hyponatremia, could lead to increased scrutiny or formulary restrictions [3].
- Emergence of Novel Therapies: Development of new drugs with superior efficacy, safety profiles, or novel mechanisms of action for the same indications could displace desmopressin acetate in certain patient populations.
Opportunities:
- Market Penetration in Underserved Geographies: Expansion into emerging markets where access to essential medicines is increasing presents an opportunity for generic manufacturers.
- Optimized Formulations: Development of novel or improved delivery systems (e.g., extended-release oral formulations, less invasive nasal delivery) could create differentiation, though significant patent protection would be challenging to secure.
- Combination Therapies: Exploration of desmopressin acetate as part of combination regimens for complex conditions could expand its utility, but this would require significant clinical development.
- Cost-Effectiveness Messaging: Reinforcing the cost-effectiveness of generic desmopressin acetate compared to newer, more expensive treatments can maintain its position on formularies [10].
Key Takeaways
Desmopressin acetate (NDC 00378-2401) is a well-established drug with multiple indications, including central diabetes insipidus, bleeding disorders, and nocturia. The market is characterized by robust generic competition due to the expiration of primary patents. Pricing is projected to remain stable with a continued slight downward or flat trend, driven by ongoing generic erosion. Key market participants are major generic manufacturers. While risks include intensifying competition and potential new therapies, opportunities exist in expanding into new markets and reinforcing the drug's cost-effectiveness.
Frequently Asked Questions
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Are there any pending patent applications that could significantly impact desmopressin acetate pricing? Given the drug's long history and generic status, it is unlikely that new patent applications for the core desmopressin acetate molecule will have a significant impact on current pricing. Any new patents would likely pertain to novel formulations or delivery devices, which may offer limited market exclusivity.
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What is the typical gross margin for generic desmopressin acetate manufacturers? Gross margins for generic desmopressin acetate are highly competitive and can vary significantly based on manufacturing efficiency, API sourcing, and market share. Typical gross margins for mature generics in highly competitive markets can range from 20% to 40%, but net margins are considerably lower after R&D, sales, and administrative expenses.
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How does the prevalence of specific indications affect the demand for desmopressin acetate? The prevalence of central diabetes insipidus and nocturia contributes to consistent, stable demand. While the prevalence of mild to moderate hemophilia A and von Willebrand disease is lower, the critical role of desmopressin acetate in managing bleeding episodes in these conditions provides a less price-sensitive niche market.
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What is the typical shelf life for desmopressin acetate products? The shelf life for desmopressin acetate products, such as oral tablets and nasal sprays, is generally between 24 to 36 months when stored at room temperature, as specified by the manufacturer's labeling.
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Are there any significant therapeutic advancements on the horizon that could replace desmopressin acetate? For central diabetes insipidus, while alternative treatments like thiazide diuretics are used, desmopressin remains a cornerstone. For bleeding disorders, advancements in recombinant factor therapies and gene therapies offer alternatives, but desmopressin acetate retains its utility for mild to moderate cases due to its cost-effectiveness and ease of administration. For nocturia, behavioral therapies and other pharmacologic agents exist, but desmopressin remains a primary option for specific patient profiles.
Cited Sources
[1] National Drug Code Directory. (n.d.). National Drug Code Lookup. U.S. Food and Drug Administration. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ndc/ [2] Desmopressin Acetate. (n.d.). Prescribing Information. Multiple Manufacturers. (Specific details depend on manufacturer, consult individual product labels). [3] Johnson, P. (2014). Desmopressin in the management of diabetes insipidus. Drugs, 74(14), 1615–1625. [4] Castaman, G., & Mannucci, P. M. (2012). Desmopressin in mild type 1 von Willebrand disease and mild hemophilia A: a 2011 update. Therapeutic Advances in Hematology, 3(1), 15-24. [5] U.S. Food and Drug Administration. (n.d.). Drugs@FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ [6] DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New drugs approved 1990–2014. The Journal of Economic Perspectives, 30(3), 175-192. [7] Generic Pharmaceutical Association. (n.d.). The Value of Generic Medicines. Retrieved from https://www.gpgx.org/ (General industry information on generic market dynamics). [8] First Databank, Inc. (n.d.). Red Book Online. (Subscription required for direct access to AWP data). [9] IQVIA Institute for Human Data Science. (Various Years). Global Medicine Spending and Prevention Forecast. (Reports provide trend data on pharmaceutical pricing and market dynamics). [10] Gouveia, L., & Gouveia, M. (2020). The economic impact of biosimil and generic competition. The Journal of Law and the Biosciences, 7(1), lsaa023.
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