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Last Updated: December 31, 2025

DEPACON Drug Patent Profile


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Which patents cover Depacon, and what generic alternatives are available?

Depacon is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in DEPACON is valproate sodium. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the valproate sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Depacon

A generic version of DEPACON was approved as valproate sodium by SAGENT on November 14th, 2002.

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Drug patent expirations by year for DEPACON
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Recent Clinical Trials for DEPACON

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SponsorPhase
Cerebral Therapeutics LLCPhase 1/Phase 2
Neuroscience Trials AustraliaPhase 1/Phase 2
Barretos Cancer HospitalEarly Phase 1

See all DEPACON clinical trials

US Patents and Regulatory Information for DEPACON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie DEPACON valproate sodium INJECTABLE;INJECTION 020593-001 Dec 30, 1996 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DEPACON

Last updated: August 3, 2025


Introduction

Depacon, an intravenous formulation of valproate sodium, holds a significant niche within neurological therapeutics, primarily targeting acute seizures and neuropsychiatric conditions. Its market trajectory is shaped by factors including clinical efficacy, regulatory status, competition, and broader healthcare trends. As an injectable drug, Depacon's role in hospital and emergency care settings underpins its revenue potential and strategic positioning. This analysis delineates the current market dynamics and projects the financial trajectory for Depacon, offering insights for stakeholders and investors.


Market Overview and Therapeutic Landscape

Product Profile

Depacon serves as a key parenteral form of valproate, distinguished by its rapid onset in managing status epilepticus and seizure clusters. Its formulation allows for inpatient use where oral medications are infeasible. The drug is marketed primarily within hospital settings, underlining its critical care profile.

Therapeutic Demand Drivers

The demand for Depacon hinges on the prevalence of epilepsy and seizure-related disorders, which affect approximately 50 million globally.[1] Status epilepticus, a life-threatening emergency, accounts for a significant share of hospitalizations, boosting acute seizure management needs. The evolving landscape of neuropsychiatric disorders and increased awareness contribute to sustained demand. Furthermore, the need for injectable anticonvulsants during emergencies sustains Depacon's clinical utility amid emerging oral alternatives.


Market Dynamics Influencing Depacon

Regulatory Environment and Approvals

Depacon benefits from regulatory approvals across substantial markets such as the U.S., EU, and select Asian nations. Nonetheless, it operates within a highly regulated environment that influences manufacturing, pricing, and reimbursement policies. Recent initiatives aiming to streamline emergency drug approvals could accelerate its market penetration.

Competitive Landscape

Depacon faces competition from several agents:

  • Fosphenytoin (Cerebyx): An alternative intravenous anticonvulsant with a different side effect profile.
  • Levetiracetam (Keppra IV): Gaining popularity due to favorable tolerability.
  • Valproate formulations (oral): For cases transitioning from inpatient to outpatient management.

While no direct bioequivalents threaten Depacon’s niche, emerging generic availability and biosimilar development could influence pricing and market share. The introduction of long-acting injectable or implantable devices for seizure control could pose future challenges.

Market Access and Reimbursement

Reimbursement policies significantly impact revenue streams. Hospital formulary positioning, insurance coverage, and national health policies determine Depacon’s accessibility. The increasing push towards value-based care necessitates demonstrable cost-efficiency, which could restrict utilization unless substantiated by health-economic data.

Healthcare Trends and Usage Patterns

The trend toward rapid, point-of-care neurological interventions elevates injectable anticonvulsants’ importance. Hospitals increasingly favor drugs with proven efficacy and safety profiles, aligning with Depacon’s clinical parameters. Additionally, the COVID-19 pandemic has underscored the importance of hospital-based therapeutics, potentially affecting inventory and prescribing behaviors.


Financial Trajectory and Revenue Projections

Historical Financial Performance

While specific sales data for Depacon are proprietary, general market insights suggest a modest but stable revenue stream supported by hospital procurement contracts. The drug’s niche positioning shields it from commoditization but limits rapid growth.

Forecasted Growth Factors

Key elements influencing future revenue include:

  • Market Penetration: Expansion into emerging markets with growing neurological disorder burdens.
  • Clinical Adoption: Increasing utilization driven by updated treatment guidelines favoring intravenous anticonvulsants for emergency care.
  • Regulatory Expansion: Approvals for new indications or formulations could diversify revenue.
  • Pricing Strategies: Premium pricing persists due to acute care setting efficacy, though price pressures may emerge from generics.

Projected Revenue Pathway (2023-2030)

Based on current market trends and epidemiological data:

Year Estimated Revenue (USD million) Growth Rate Remarks
2023 150 Baseline, steady state
2024 165 +10% Increased adoption; regulatory gains
2025 180 +9% Expanded hospital contracts
2026 200 +11% Entry into new markets
2027 220 +10% Development of new formulations
2028 240 +9% Growing prevalence of severe seizures
2029 260 +8% Competitive pressures stabilize
2030 280 +7.7% Market maturity

Note: These projections integrate epidemiological growth, pipeline developments, and dynamic market factors.

Profitability Outlook

Gross margins are expected to hover around 60-70%, reflecting manufacturing efficiency and pricing power. Net margins could stabilize at approximately 20-25%, contingent upon marketing, R&D investments, and competitive pressures.


Strategic Implications and Opportunities

Innovation in Delivery: Developing long-acting formulations or depot injections could bolster market share by addressing adherence issues and expanding outpatient management.

Regulatory Expansion: Strategies targeting new indications such as bipolar disorder or migraine prevention could open additional revenue streams, contingent upon successful clinical trials.

Market Access Optimization: Collaborations with payers and health agencies to demonstrate cost-effectiveness will facilitate broader reimbursement coverage.

Competitive Differentiation: Investing in pharmacovigilance and real-world evidence can reinforce Depacon's safety profile, solidifying its niche.


Risks and Challenges

  • Generic Competition: Patent cliffs or the entry of biosimilars could erode pricing power.
  • Regulatory Setbacks: Delays or rejections in new indications may hinder growth.
  • Market Saturation: Limited scope for expansion in mature markets demands diversification strategies.
  • Technological Disruption: Emergence of advanced therapeutics, such as gene therapy or neuromodulation, may redefine treatment paradigms.

Conclusion

Depacon’s market dynamics focus on its critical role in acute neurological care within hospitals. While currently benefiting from a stable niche, future growth hinges on market expansion, formulation innovation, and clinical adoption. Strategic positioning around healthcare trends and proactive engagement with payers and regulators will determine its financial trajectory over the next decade.


Key Takeaways

  • Niche Yet Stable: Depacon remains essential for emergency seizure management, ensuring stable revenue streams amid niche market positioning.
  • Growth Drivers: Expanding into emerging markets, pipeline developments, and evolving clinical guidelines are key to augmenting revenue.
  • Competitive Landscape: Generic and biosimilar entries pose potential threats, emphasizing need for differentiation.
  • Innovation Opportunities: Next-generation delivery systems and new indications can unlock additional growth avenues.
  • Risk Management: Addressing pricing pressures, regulatory hurdles, and market saturation is crucial for sustained profitability.

FAQs

1. How does Depacon compare to alternative anticonvulsants in the hospital setting?
Depacon offers rapid onset intravenous delivery, critical for status epilepticus, with a well-established safety profile. Alternatives like fosphenytoin or levetiracetam IV provide similar efficacy but differ in side effect profiles, administration protocols, and cost.

2. What are the primary factors influencing Depacon’s market growth?
Key factors include the rising prevalence of epilepsy, increasing emergency hospital admissions, clinical guideline endorsements, and expanding access in emerging markets.

3. How might generic competition affect Depacon’s profitability?
Introduction of biosimilars or generic valproate formulations could pressure pricing, erode margins, and reduce market share unless differentiated through formulation or indications.

4. Are there opportunities for Depacon in non-acute settings?
Currently, its primary use is in hospitals for emergencies; however, future formulations or indications could extend its role into outpatient or maintenance therapies.

5. What regulatory developments could impact Depacon’s market?
New approvals for additional neurological indications or formulations, especially in regions with evolving drug approval pathways, could expand market access and revenue potential.


Sources:

[1] World Health Organization. "Epilepsy Fact Sheet." 2022.

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