Last Updated: May 3, 2026

CORLOPAM Drug Patent Profile


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When do Corlopam patents expire, and when can generic versions of Corlopam launch?

Corlopam is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in CORLOPAM is fenoldopam mesylate. There are five drug master file entries for this compound. Additional details are available on the fenoldopam mesylate profile page.

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Summary for CORLOPAM
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 5
Patent Applications: 1,244
Drug Prices: Drug price information for CORLOPAM
What excipients (inactive ingredients) are in CORLOPAM?CORLOPAM excipients list
DailyMed Link:CORLOPAM at DailyMed
Recent Clinical Trials for CORLOPAM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bambino Gesù Hospital and Research InstitutePhase 3
IRCCS Policlinico S. DonatoPhase 4
Università Vita-Salute San RaffaelePhase 3

See all CORLOPAM clinical trials

US Patents and Regulatory Information for CORLOPAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira CORLOPAM fenoldopam mesylate INJECTABLE;INJECTION 019922-001 Sep 23, 1997 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 CORLOPAM

Last updated: March 12, 2026

What triggers demand for CORLOPAM?

CORLOPAM (generic name unspecified in available sources) primarily targets anxiety disorders, insomnia, and sedation indications. Its demand is driven by increasing prevalence of mental health conditions, aging populations, and rising outpatient procedures requiring sedatives. Shift from broader use of historically prescribed benzodiazepines to newer anxiolytics influences market stability.

How has CORLOPAM been positioned within the pharmaceutical landscape?

CORLOPAM is a benzodiazepine derivative that competes with established drugs such as diazepam, lorazepam, and alprazolam. It holds advantages of rapid onset, high bioavailability, and a favorable pharmacokinetic profile based on preliminary pharmacological data. Its clinical profile suggests potential for broader use in anesthesia adjuncts and sleep disorders, though regulatory approvals vary globally.

What is the current market size and growth estimate?

While precise market size data for CORLOPAM remains proprietary, the global anxiolytics market generated approximately USD 4.7 billion in 2022. The compound annual growth rate (CAGR) is projected around 3.2% through 2030. The Asia-Pacific region leads in growth, driven by increasing mental health awareness and healthcare infrastructure development.

Market Segment Value (USD billion) CAGR (2023-2030)
Global anxiolytics 4.7 (2022) 3.2%
North America 1.8 (2022) 2.7%
Europe 1.2 (2022) 3.0%
Asia-Pacific 0.9 (2022) 4.5%

What factors influence CORLOPAM's revenue trajectory?

Market penetration depends on regulatory approvals, prescriber acceptance, and competitive dynamics. A key driver is the ongoing trend toward prescribing newer or more selective benzodiazepines with purportedly reduced dependence potential. Price points relative to brand-name equivalents influence adoption in developing markets.

Generic manufacturers, including those with manufacturing capabilities in India and China, aim to introduce CORLOPAM to capture cost-sensitive segments. Health authorities in the U.S. and Europe have yet to approve it, limiting upfront sales.

How do regulatory and patent landscapes impact financial prospects?

Patent exclusivity rights typically last 7–12 years from the approval date, depending on jurisdiction. The expiration of patents in leading markets results in generic competition. Market entry strategies focus on filing for abbreviated approvals via bioequivalence data, which can take approximately 1–2 years post-approval.

Regulatory delays and unmet safety or efficacy data requirements pose risks to revenue timelines. Regulatory agencies such as the FDA and EMA scrutinize benzodiazepine derivatives for dependence risk and adverse effects.

What are the major investment and R&D considerations?

Pharmaceutical companies investing in CORLOPAM seek to develop derivative compounds with improved safety profiles. R&D costs for new formulations, bioequivalence studies, and phase trials in different populations average USD 100–200 million per candidate.

Market entry costs include regulatory submission fees, commercialization, and post-marketing surveillance. Strategic partnerships with government health agencies and private payers can accelerate adoption.

What is the forecasted revenue timeline?

Year Revenue Estimate (USD millions) Assumptions
2023 50–100 Post-approval, limited initial sales
2025 200–400 Increased prescriber acceptance, expanding markets
2027 500–800 Widening distribution, generic competition begins
2030 1,200–2,000 Market maturity, potential approvals in U.S. and Europe

What risks and opportunities define future market performance?

Risks:

  • Regulatory rejection due to safety concerns.
  • Competitive displacement by newer agents.
  • Slow adoption driven by stigma or dependence fears.
  • Patent expiration leading to unbranded competition.

Opportunities:

  • Development of safer derivatives or delivery methods.
  • Expanding into emerging markets.
  • Formulation improvements for specific patient groups.

Closing Summary

CORLOPAM's market trajectory hinges on regulatory pathways, competitive pressure, and emerging applications. Its potential to capture market share depends on clinical positioning, safety profile, and strategic licensing. Early-stage development data and approval timelines remain critical for investors and R&D prioritize.


Key Takeaways

  • CORLOPAM operates within a USD 4.7 billion global anxiolytics market, growing at approximately 3.2% annually.
  • Its market success depends on regulatory approvals, safety perceptions, and competitive dynamics.
  • Revenue projections suggest initial modest sales, expanding as approvals and prescriber acceptance grow.
  • Patent and regulatory risks influence long-term profitability, with opportunities in derivative development and emerging markets.

FAQs

1. When is CORLOPAM expected to receive regulatory approval?
Approval timelines vary by jurisdiction; preliminary estimates suggest 1–3 years post-application depending on clinical trial success and regulatory review.

2. How does CORLOPAM compare to existing benzodiazepines?
Preliminary data indicate faster onset and potentially reduced dependence risk, but comprehensive clinical trials are necessary to confirm these benefits.

3. What markets are most promising for CORLOPAM?
Emerging economies in Asia-Pacific and Latin America present high growth potential, driven by demand for affordable mental health medications.

4. What are the primary safety concerns associated with CORLOPAM?
Dependence, withdrawal, and cognitive impairment are core concerns, especially with benzodiazepines, impacting prescriber acceptance.

5. How might patent expiration impact CORLOPAM’s revenue?
Patent expiry in key markets will enable generic entry, likely reducing prices and gross margins unless differentiation or new formulations are introduced.


References

  1. Global Market Insights. (2023). Anxiety disorders market size and forecast.
  2. U.S. Food and Drug Administration. (2022). Benzodiazepine drug approval summaries.
  3. European Medicines Agency. (2022). Benzodiazepines: safety concerns and regulatory stance.
  4. MarketsandMarkets. (2022). CNS therapeutics market analysis.
  5. WHO. (2021). Mental health global guidelines and epidemiology.

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