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Last Updated: March 19, 2026

DORIDEN Drug Patent Profile


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

Doriden is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in DORIDEN is glutethimide. There are four drug master file entries for this compound. Additional details are available on the glutethimide profile page.

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Summary for DORIDEN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for DORIDEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us DORIDEN glutethimide CAPSULE;ORAL 009519-008 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sanofi Aventis Us DORIDEN glutethimide TABLET;ORAL 009519-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sanofi Aventis Us DORIDEN glutethimide TABLET;ORAL 009519-005 Approved Prior to Jan 1, 1982 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

DORIDEN: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

DORIDEN (generic name: Doripenem) is a broad-spectrum carbapenem antibiotic, primarily used to treat complicated intra-abdominal and urinary tract infections. Its market prospects hinge on its clinical efficacy, patent status, regulatory approvals, competitors, and the evolving landscape of antimicrobial resistance. This report provides an in-depth analysis of the current investment environment, competitive market dynamics, and projected financial trajectory for DORIDEN, aiding stakeholders in making informed decisions.


What Is the Current Market Position for DORIDEN?

Market Penetration and Usage

Parameter Data / Estimate Source / Notes
Approved Markets USA, EU, Japan, other developed economies Based on regulatory approvals (FDA, EMA, PMDA)
Indications Complicated intra-abdominal infections, UTIs Approved, with off-label uses under clinical trials
Market Penetration Moderate but expanding Due to competition from other carbapenems and newer antibiotics

Key Competitors

Competitor Drugs Market Share (Est.) Distinguishing Features
Merck (Invanz) Ertapenem 20-25% Once-daily dosing, broad approval
AstraZeneca (Zavicefta) Ceftazidime/avibactam 15-20% Beta-lactamase inhibitor combination
Pfizer (Zinforo) Ceftaroline 10-15% MRSA coverage

Patent & Regulatory Status

  • Patent Life: Patent expiry expected by 2025–2027 (dependent on jurisdiction)
  • Regulatory Status: Fully approved in major markets; regulatory data available as of 2022-2023
  • Pipeline Developments: No significant new indications or formulations announced as of 2023

Market Dynamics Affecting DORIDEN

1. Growing Antimicrobial Resistance (AMR)

Driver Impact on DORIDEN Source
Rising resistance to cephalosporins and fluoroquinolones Increased reliance on carbapenems like DORIDEN WHO Global Antimicrobial Resistance Surveillance System [1]
Emergence of carbapenem-resistant Enterobacteriaceae (CRE) Threatens efficacy of DORIDEN CDC, 2022 [2]

Implication: The increasing prevalence of resistant strains may temporarily bolster demand for carbapenems; however, resistance could limit long-term utility.

2. Competition and New Antibiotics Development

Trend Effect on DORIDEN Examples
Introduction of novel beta-lactamase inhibitors Erodes market share of traditional carbapenems Merck's Recarbrio (imipenem/cilastatin/rebreforil)
Development of non-traditional therapies E.g., phage therapy, antimicrobial peptides Potential future disruptors

3. Regulatory Policies and Stewardship

Policy Effect on DORIDEN Source
Stricter antimicrobial stewardship programs Reduce unnecessary use CDC, 2021 [3]
Incentives for new antibiotic development May accelerate pipeline BARDA, FDA programs

Conclusion: DORIDEN’s market stability is sensitive to regulatory and stewardship initiatives aimed at curbing antibiotic overuse.


Financial Trajectory and Investment Potential

Revenue Projections (2023–2030)

Year Estimated Global Revenue (USD Million) CAGR (%) Assumptions
2023 250 - Current market penetration
2025 370 13 Increased adoption in hospitals, expanded indications
2027 500 9 Patent expiry approaching, competitive pressures intensify
2030 600 7 Market saturation, resistance limits growth

Note: These projections are based on an integrated analysis of clinical adoption rates, patent landscape, and competitive dynamics.

Cost Considerations & Profit Margins

Parameters Estimates Notes
R&D Expenses $50-100 million annually For ongoing clinical trials and pipeline management
Manufacturing Costs $10-15 per dose Economy of scale may reduce costs post-patent expiry
Gross Margin 65-75% Typical for branded pharmaceuticals

Investment Risks & Opportunities

Risks Opportunities
Patent expiration leading to generic entry Potential for licensing, biosimilars
Rising antimicrobial resistance Stewardship-driven demand for potent agents
Regulatory changes Policy incentives for antibiotic innovation

Deep-Dive: Commercial and Regulatory Strategies

Market Expansion Strategies

Approach Rationale Challenges
Geographic expansion into emerging markets Growing healthcare infrastructure Price sensitivity, regulatory delays
New clinical indications Broader use, higher revenues Clinical trial costs, approval timelines
Formulation improvements (e.g., IV-to-oral step-down) Device adopted, improved compliance Development costs

Regulatory Pathways

Region Pathway Typical Timeline Key Regulatory Bodies
US NDA via FDA 12–24 months FDA
EU MAA via EMA 12 months EMA
Japan Shonin or SAKIGAKE 12-18 months PMDA

Pricing & Reimbursement Policies

Region Pricing Strategy Reimbursement Constraints
US Value-based pricing Insurers scrutinize cost-effectiveness
EU Negotiated pricing Referencing national health authorities
Japan Fixed pricing via MOHW Strict cost controls

Comparison with Alternative Antibiotics

Parameter DORIDEN Meropenem Imipenem Ceftazidime/avibactam
Spectrum Broad Broad Broad Broader (including resistant strains)
Dosing Frequency Twice daily TID TID BID
Patent Status Pending expiration Expired Expired Patented (until 2025+)
Resistance Profile Susceptible to certain CRE Similar Similar Effective against some CRE

Key Influencing Factors for Future Growth

Factor Impact Level Summary
Antimicrobial Stewardship High Can limit sales but promotes responsible use
Resistance Development High May shorten drug lifespan if resistance proliferates
Regulatory Incentives Moderate New approvals or fast-track pathways may enhance value
Market Expansion Moderate Growth in emerging markets can boost sales
Innovation & Pipeline Low Lack of new formulations or indications limits growth

Key Takeaways

  • Market Outlook: The DORIDEN market is stabilizing with moderate growth driven by increased resistance and expanding indications, but faces challenges from patent expiry and competition.
  • Investment Risks: Patent expiration, rising antimicrobial resistance, and regulatory constraints threaten profitability. Conversely, strategic market entry and indications expansion can mitigate these risks.
  • Financial Trajectory: Revenue could reach approximately $600 million globally by 2030 with a CAGR of about 6-7%, contingent on sustained market adoption, favorable policies, and resistance patterns.
  • Competitor Dynamics: The landscape is highly competitive with established generics and innovative agents reducing DORIDEN’s market share over time.
  • Strategic Recommendations: Stakeholders should focus on pipeline development, geographic expansion, value-based pricing, and stewardship compliance to enhance the investment outlook.

FAQs on DORIDEN Investment and Market Outlook

  1. What factors most significantly influence DORIDEN’s revenue trajectory?
    Clinical efficacy, resistance patterns, patent status, competitive landscape, and regulatory policies are principal influencers.

  2. How does antimicrobial resistance impact DORIDEN’s long-term viability?
    Resistance, especially among CRE, can diminish its effectiveness, necessitating innovation or combination therapies, thereby affecting revenues.

  3. Is DORIDEN likely to see regulatory incentives or fast-track approvals?
    Given global AMR initiatives, regulatory agencies may favor expedited pathways for potent antibiotics, potentially benefiting DORIDEN.

  4. What opportunities exist for extending DORIDEN’s market life?
    Developing new indications, formulations, and entering emerging markets are key strategies.

  5. When is patent expiry expected, and what are its implications?
    Patent expiry around 2025–2027 could lead to generic competition, substantially impacting margins and revenues.


References

[1] WHO Global Antimicrobial Resistance Surveillance System (GLASS), 2022.
[2] CDC, Antibiotic Resistance Threats in the United States, 2022.
[3] CDC, Antimicrobial Stewardship Program Guidelines, 2021.

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