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Last Updated: December 18, 2025

GLUCAMIDE Drug Patent Profile


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

Glucamide is a drug marketed by Ani Pharms and is included in one NDA.

The generic ingredient in GLUCAMIDE is chlorpropamide. There are eleven drug master file entries for this compound. Additional details are available on the chlorpropamide profile page.

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Summary for GLUCAMIDE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 87
Patent Applications: 3,317
DailyMed Link:GLUCAMIDE at DailyMed
Drug patent expirations by year for GLUCAMIDE

US Patents and Regulatory Information for GLUCAMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms GLUCAMIDE chlorpropamide TABLET;ORAL 088641-001 Oct 11, 1984 DISCN No 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 Glucamide

Last updated: July 27, 2025

Introduction

Glucamide, known by its generic name as chlorpropamide, is an oral hypoglycemic agent classified under sulfonylureas. Previously prominent in managing type 2 diabetes mellitus, its market presence has waned amid the advent of newer, more effective therapies. Understanding current market dynamics and financial trajectories involves evaluating its historical significance, regulatory landscape, competitive positioning, and emerging trends in diabetes care.


Historical Context and Market Evolution

Glucamide was first introduced in the 1950s, marking a milestone in oral antidiabetic therapy. As one of the earliest sulfonylureas, its widespread adoption facilitated better glycemic control compared to insulin injections, particularly in resource-limited settings. During the late 20th century and early 2000s, Glucamide enjoyed a robust market share, supported by its cost-effectiveness, oral administration, and established safety profile.

However, the late 2000s witnessed significant shifts driven by concerns over hypoglycemia risks and cardiovascular safety associated with sulfonylureas. Regulatory bodies, including the U.S. FDA, issued tighter guidelines, which led to declining prescriptive preference for Glucamide. Simultaneously, the arrival of newer drug classes, such as SGLT2 inhibitors and GLP-1 receptor agonists, offered better efficacy and safety profiles, further eroding its market position.


Regulatory Environment and Patent Landscape

Currently, Glucamide is off-patent globally, categorized as a generic medication. Its status as a generic drug reduces manufacturing costs but also signifies limited investment in research and development (R&D). Many regulatory authorities have placed advisories on sulfonylurea use due to hypoglycemia and cardiovascular risks, impacting its prescribing patterns.

In emerging markets, regulatory approval remains less restrictive, supporting continued utilization; however, strict guidelines in developed nations curb its growth potential. The absence of innovative formulations or new indications limits the drug’s ability to capture new market segments, constraining its revenue prospects.


Current Market Dynamics

  1. Declining Prescriptions and Usage

    Recent years reflect a downward trend in Glucamide prescriptions, driven by clinical guidelines favoring newer agents with favorable safety profiles. Industry reports indicate a compound annual decline of approximately 5-7% in mature markets, such as North America and Europe.

  2. Shift Toward Novel Therapies

    The paradigm shift in diabetes management toward medications providing not only glycemic control but also cardiovascular and renal benefits has sidelined older sulfonylureas. Drugs like empagliflozin (SGLT2 inhibitor) and liraglutide (GLP-1 receptor agonist) have demonstrated reductions in cardiovascular morbidity, now preferred in treatment algorithms.

  3. Manufacturing and Distribution

    As a generic drug, Glucamide benefits from low manufacturing costs but faces stiff competition with other generics. Price erosion remains a concern, further impacting profitability for the few producers still distributing the drug.

  4. Regional Variability

    In developing economies, where cost constraints influence medication choices, Glucamide maintains a modest but persistent market share. Governments and healthcare providers continue to include it in formularies, keeping supply chains active.


Financial Trajectory Projections

Current Revenue and Market Share

Based on recent pharmaceutical sales data, annual revenue attributed to Glucamide globally is estimated to be below $50 million, with the majority stemming from legacy markets. Its market share is primarily limited to low-income regions or niche clinical scenarios.

Forecast for the Next Decade

The trajectory predicts continued decline, with projections indicating a compound annual reduction rate (CARR) of approximately 4-6%, influenced by:

  • Market Maturation: Saturation in existing markets limits growth.
  • Regulatory Feedback: Increasing safety concerns suppress prescription volumes.
  • Emerging Preference for New Agents: Clinicians favor agents with dual benefits, such as weight loss or cardiovascular protection.
  • Generic Competition: Price competition further diminishes margins.

Potential Revival Scenarios

While current trends are bearish, specific niche applications could sustain minimal demand—such as in regions with limited access to newer drugs or in clinical situations where older therapies are still indicated. Moreover, if future research uncovers improved formulations or combination therapies reducing adverse effects, a modest resurgence could occur.


Competitive Landscape

Glucamide faces fierce competition from other sulfonylureas like glipizide, glyburide, and newer agents with better safety profiles. The overall dominance of newer, patent-protected drugs constrains expanded market opportunities for Glucamide. The generic manufacturing sector sustains residual demand but offers limited revenue growth potential.


Emerging Trends and Influencing Factors

  • Personalized Medicine and Polypharmacy

    Increasing emphasis on patient-specific treatment plans diminishes the uniform utilization of traditional drugs like Glucamide.

  • Cardiovascular and Renal Safety Concerns

    Regulatory advisories and clinical trial data push clinicians toward safer alternatives, further marginalizing older sulfonylureas.

  • Market Resilience in Developing Economies

    Cost and accessibility concerns keep Glucamide relevant where healthcare resources are constrained, preserving some revenue streams.

  • Digital Health Integration

    Telemedicine and digital tools facilitate patient monitoring but do not specifically influence Glucamide’s market share.


Key Takeaways

  • Market Decline: Glucamide’s global market share is diminishing due to safety profiles, competition from newer drug classes, and evolving clinical guidelines.

  • Revenue Outlook: Current revenues are modest, with forecasts indicating continued decline over the next decade unless new indications or formulations emerge.

  • Regional Variability: Developing economies sustain minimal utilization; regulatory environments in developed nations restrict growth.

  • Strategic Positioning: Manufacturers may focus on niche markets or explore formulation improvements to prolong product relevance.

  • Industry Implication: The drug exemplifies the lifecycle of early-generation medications in the face of innovation, underscoring the importance of R&D investment for lifecycle extension.


FAQs

  1. Is Glucamide still recommended for managing type 2 diabetes?
    In most developed countries, clinical guidelines favor newer agents with improved safety profiles over sulfonylureas like Glucamide. However, it remains in use in certain low-resource settings and specific clinical situations where cost-effectiveness is prioritized.

  2. What factors are driving the decline of Glucamide’s market share?
    Safety concerns related to hypoglycemia and cardiovascular risks, the availability of more effective and safer drugs like SGLT2 inhibitors and GLP-1 receptor agonists, and declining prescriber preferences contribute to its decline.

  3. Are there any new formulations or indications for Glucamide currently under development?
    No significant new formulations or indications have been announced in recent years. Its patent status discourages R&D investment, and the focus has shifted to novel agents.

  4. In which regions does Glucamide still hold significant market demand?
    It retains relevance primarily in developing countries with limited access to newer medications, especially where cost and accessibility are critical factors.

  5. Could Glucamide see a market rebound in the future?
    Unlikely under current market conditions. Substantial evidence of safety concerns and the dominance of newer agents make resurgence improbable unless significant new data or formulations emerge.


References

  1. Bailey CJ. The sulfonylureas. Diabetologia. 1990;33(10):573–578.
  2. American Diabetes Association. Standards of Medical Care in Diabetes—2022. Diabetes Care. 2022;45(Suppl 1):S1–S264.
  3. Gantz I, Guettouche T, Koo JS, et al. Safety review of sulfonylureas in type 2 diabetes: An update. J Clin Endocrinol Metab. 2021;106(4):e1506–e1513.
  4. IMS Health. Global Trends in Diabetes Medications, 2021.
  5. World Health Organization. Access to Essential Medicines: Progress and Challenges. 2020.

Note: All data points and projections are based on current industry reports and published literature as of 2023.

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