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Last Updated: December 12, 2025

LEVO-DROMORAN Drug Patent Profile


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Which patents cover Levo-dromoran, and when can generic versions of Levo-dromoran launch?

Levo-dromoran is a drug marketed by Valeant Pharm Intl and is included in two NDAs.

The generic ingredient in LEVO-DROMORAN is levorphanol tartrate. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the levorphanol tartrate profile page.

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Questions you can ask:
  • What is the 5 year forecast for LEVO-DROMORAN?
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Summary for LEVO-DROMORAN
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 11
DailyMed Link:LEVO-DROMORAN at DailyMed
Drug patent expirations by year for LEVO-DROMORAN

US Patents and Regulatory Information for LEVO-DROMORAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharm Intl LEVO-DROMORAN levorphanol tartrate INJECTABLE;INJECTION 008719-001 Dec 19, 1991 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Valeant Pharm Intl LEVO-DROMORAN levorphanol tartrate TABLET;ORAL 008720-001 Dec 19, 1991 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

Last updated: July 30, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: LEVO-DROMORAN

Introduction
Levo-Dromoran, a semi-synthetic opioid analgesic, is primarily utilized in the management of moderate to severe pain. As a derivative of morphine, its pharmacodynamics and clinical efficacy underpin its market presence. This report examines the current market landscape, competitive positioning, regulatory environment, and long-term financial outlook for Levo-Dromoran within the global pharmaceutical industry.


Market Overview

Global Pain Management Market
Levo-Dromoran operates within the broader pain management sector, projected to reach USD 92.4 billion by 2028, growing at a CAGR of approximately 4.3% (2021–2028) [1]. This growth is driven by increasing prevalence of chronic pain, expanding aging populations, and rising adoption of opioid-based therapies.

Therapeutic Positioning
Levo-Dromoran’s role as an opioid analgesic positions it amidst a competitive landscape featuring drugs like morphine, oxycodone, fentanyl, and tramadol. Its distinguishable features are its potency, pharmacokinetics, and safety profile, which influence clinical decision-making and prescribing patterns.


Market Dynamics

Regulatory Landscape and Prescription Trends
Globally, opioids face a complex regulatory environment. Governments are implementing stringent controls to curb misuse while ensuring access for legitimate medical use. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have reinforced opioid prescribing guidelines, impacting sales volume. However, in regions with less restrictive policies, the demand remains stable or increasing.

Epidemiology and Patient Demographics
The rising incidence of postoperative pain, cancer-related pain, and chronic musculoskeletal conditions fuels demand for potent opioids like Levo-Dromoran [2]. Aging populations in North America, Europe, and parts of Asia are driving increased opioid prescriptions, especially in palliative and hospice care.

Competitive Landscape and Market Share
Levo-Dromoran faces intense competition from established opioids. Proprietary formulations, dosage flexibility, and safety profile influence market acceptance. Patent expirations for similar drugs and the emergence of combination therapies could influence its market share.

Supply Chain and Manufacturing Considerations
Opioids manufacturing involves strict regulatory oversight, risk of shortages, and scrutiny over diversion and misuse. Manufacturers investing in compliant, scalable production capabilities are better positioned to capitalize on market demand.


Financial Trajectory

Revenue Streams and Pricing Strategy
Levo-Dromoran's revenue depends on dosage forms, pricing policies, and regional market penetration. Premium pricing can be justified through enhanced safety features or unique formulations, but price sensitivity remains high in certain markets. Price erosion due to generics or biosimilars can impact profit margins.

Market Penetration and Expansion Potential
Emerging markets such as Asia-Pacific present growth avenues due to increasing healthcare infrastructure and rising pain management awareness. Strategic marketing, localized regulations, and partnerships could accelerate expansion.

Patent and Intellectual Property
Patent protection for proprietary formulations prolongs exclusivity and revenue streams. Patent cliffs threaten generic entry, pressuring the financial outlook. Companies investing in novel delivery systems or combination drugs can sustain competitive advantage.

Regulatory and Legal Risks
Regulatory approval delays, post-market surveillance requirements, and litigation risks directly influence financial performance. Recent heightened scrutiny over opioid misuse raises potential liabilities and constrains market growth.

Forecasted Financial Performance
Based on current trends, revenue growth for Levo-Dromoran is projected to be moderate, averaging around 3–5% annually over the next five years, assuming steady regulatory conditions and clinical acceptance. However, potential disruptions such as increased litigation or shifts toward non-opioid pain therapies could impact this trajectory.


Future Outlook and Strategic Considerations

Innovations and R&D
Investment in formulation innovations—such as abuse-deterrent formulations—and alternative delivery methods (transdermal patches, sustained-release systems) could enhance market penetration and safety. Collaboration with biotech firms on combination therapies (e.g., opioid with non-opioid analgesics) offers higher-value propositions.

Market Access and Reimbursement
Engagement with healthcare payers and policymakers is crucial to secure favorable reimbursement policies. Demonstrating cost-effectiveness and safety profiles can mitigate pricing pressures.

Regulatory Adaptations
Monitoring changing regulations, especially regarding opioid prescriptions, is essential. Proactive compliance and transparent pharmacovigilance will safeguard market access and brand reputation.

SWOT Analysis

  • Strengths: Established clinical efficacy, brand recognition among opioid therapies, potential for formulation innovation.
  • Weaknesses: Regulatory hurdles, misuse potential, competitive pressure from generics.
  • Opportunities: Expansion in emerging markets, development of abuse-deterrent formulations.
  • Threats: Regulatory crackdowns, alternative pain management therapies, societal opioid crisis.

Key Takeaways

  • The opioid analgesic market is under pressure due to regulatory and societal challenges, but demand persists in specific clinical settings.
  • Levo-Dromoran’s financial prospects hinge on innovative formulations, regional expansion, and maintaining a favorable safety profile.
  • Market growth is predominantly driven by aging populations and increasing chronic pain prevalence, notably in North America and Europe.
  • Patent strategies, regulatory compliance, and proactive risk management are essential to sustain revenue streams.
  • Emerging markets present compelling growth opportunities, provided companies adapt to local regulatory and cultural contexts.

Conclusion

Levo-Dromoran's market dynamics are shaped by complex healthcare policies, evolving clinical practices, and societal factors influencing opioid prescribing. While growth prospects remain favorable in niche segments and emerging markets, the long-term financial trajectory depends greatly on product innovation, regulatory navigation, and societal shifts toward alternative pain management modalities. Firms that strategically position Levo-Dromoran through technological advancements and market expansion will better mitigate risks and capitalize on burgeoning demand.


FAQs

1. What are the main factors influencing Levo-Dromoran’s market demand?
Demand is driven by the prevalence of chronic and acute pain, aging populations, prescriber preferences, regulatory policies, and the drug’s clinical efficacy and safety profile.

2. How do regulatory changes impact the sales of Levo-Dromoran?
Tighter regulations and prescribing guidelines can reduce sales volume, while relaxed policies in certain regions may expand access. Regulatory approval delays and post-market surveillance requirements also influence the financial outlook.

3. What competitive advantages does Levo-Dromoran hold over other opioids?
Its pharmacokinetic profile, potency, and safety features—particularly if formulated as abuse-deterrent—can differentiate it. Strategic patent protections and formulation innovations further bolster its market position.

4. How can pharmaceutical companies mitigate risks associated with opioid misuse?
Implementing abuse-deterrent formulations, strict distribution controls, patient education, and robust pharmacovigilance programs help minimize misuse risks and comply with regulatory standards.

5. What is the outlook for Levo-Dromoran in emerging markets?
Emerging markets present growth potential owing to increasing healthcare infrastructure and pain management needs. Success depends on navigating local regulations, pricing strategies, and cultural acceptance of opioids.


References

[1] Markets and Markets. Pain Management Market, 2021–2028.

[2] World Health Organization. Global Burden of Disease Study, Pain Epidemiology Report.

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