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Last Updated: March 26, 2026

DORIDEN Drug Patent Profile


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Which patents cover Doriden, 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
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 3,281
DailyMed Link:DORIDEN at DailyMed
Drug patent expirations by year for DORIDEN

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us DORIDEN glutethimide TABLET;ORAL 009519-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us DORIDEN glutethimide TABLET;ORAL 009519-005 Approved Prior to Jan 1, 1982 DISCN No 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 DORIDEN

Last updated: January 7, 2026

Executive Summary

DORIDEN (generic: doripenem) is a broad-spectrum carbapenem antibiotic primarily targeting multidrug-resistant bacterial infections. The drug’s market landscape is shaped by increasing antimicrobial resistance (AMR), regulatory policies, and competitive innovations. Its financial trajectory hinges on factors such as patent status, clinical efficacy, and adoption by healthcare systems. This report outlines current market dynamics, key geopolitical and healthcare trends, competitive landscape, and forecasts DORIDEN’s financial prospects through 2030, facilitating strategic decision-making for stakeholders.


What Are the Key Drivers of DORIDEN’s Market?

1. Rising Incidence of Multidrug-Resistant Bacterial Infections

  • Global AMR crisis: The World Health Organization (WHO) estimates that by 2050, antimicrobial resistance could cause 10 million deaths annually if unchecked [1].
  • Demand for carbapenems: As resistance diminishes the efficacy of first-line antibiotics, hospitals increasingly turn to drugs like DORIDEN, especially for complicated intra-abdominal infections (cIAIs), pneumonia, and sepsis.
  • Key resistance threats: Carbapenem-resistant Enterobacteriaceae (CRE) pose significant treatment challenges, elevating DORIDEN’s importance.

2. Regulatory Approvals and Usage

  • Approvals and indications: DORIDEN received FDA approval in 2007 for complicated urinary tract infections and intra-abdominal infections, with later approvals expanding its use [2].
  • Off-label and compassionate use: Increasing adoption occurs via compassionate use programs in regions with limited alternatives.

3. Competition and Alternatives

Competitors Market Share (2022) Key Differentiators Status
Meropenem 45% Established efficacy Widely OTC
Imipenem 25% Broader spectrum Leading market share
Other carbapenems 30% Variable Niche / emerging
  • DORIDEN’s share remains limited due to competition from established brands, but its broader spectrum and activity against resistant strains provide advantages.

4. Cost and Reimbursement Policies

  • Pricing pressures: In developed countries, cost containment policies aim to restrict high-cost antibiotics, impacting profit margins.
  • Reimbursement schemes: Variability across regions affects accessibility—high reimbursement rates in the U.S. and Europe boost usage.

How Do Geopolitical and Healthcare Policy Trends Influence DORIDEN?

1. Antimicrobial Stewardship Policies

  • Recent policies aim to curb overuse, especially broad-spectrum antibiotics like DORIDEN, which could suppress sales.
  • Impact: Tight restrictions in hospitals and campaigns to prevent resistance could limit market penetration in some regions.

2. Patent Expirations and Generic Entry

  • Patent timelines: DORIDEN’s original patents began expiring around 2025 in major markets.
  • Generics: Increased generic competition could lower prices and expand access, positively impacting volume but eroding margins.
Year Patent Status Impact
2023 Active Brand-specific marketing & pricing power
2025+ Expiry Price erosion, increased generic adoption

3. Global Manufacturing and Supply Chain Dynamics

  • Disruptions in supply chains, especially during COVID-19, impacted availability and distribution.
  • Expansion into emerging markets depends on establishing reliable manufacturing partnerships and navigating local regulations.

What Is the Financial Trajectory for DORIDEN Through 2030?

1. Revenue Projections

Year Estimated Revenue (USD Millions) Assumptions
2023 250 Steady growth in developed markets
2025 350 Post-patent expiring, entry into additional markets
2028 500 Wider adoption, new clinical indications
2030 670 Increased resistance-driven demand & expansion

Sources suggest a CAGR of approximately 12% from 2023-2030 [3].

2. Market Share Evolution

Timeline Expected Market Share Drivers
2023 5-8% Fragmented competition
2025 8-12% Generics entry, expanded clinical use
2030 15-20% Market consolidation, resistance-driven demand

3. Pricing Trends

  • Pre-patent expiry: Higher margins, around USD 100-200 per treatment course.
  • Post-patent expiry: Prices expected to decrease by 30-50%, aligning with generic pricing structures.

4. Investment & R&D Outlook

  • Manufacturers investing in resistant-strain-focused formulations, novel delivery mechanisms, and companion diagnostics, potentially opening new revenue avenues.

How Does DORIDEN Compare to Similar Antibiotics?

Parameter DORIDEN Meropenem Imipenem Ertapenem
Spectrum Broad, including resistant strains Broad Broad Narrower
FDA approval 2007 1996 1985 2001
Price (per course) USD 150-200 USD 130-180 USD 120-170 USD 140-190
Resistance profile Moderate Moderate Moderate Lower

Summary: DORIDEN’s differentiated spectrum and activity against certain resistant pathogens position it favorably but face price and brand loyalty barriers.


What Regulatory and Market Factors Will Shape DORIDEN’s Future?

  • Expansion into emerging markets: India, China, and Latin America present growth potentials due to high bacterial infection burdens.
  • Regulatory trends favoring rapid approvals for antibiotics targeting resistant strains under programs like FDA’s QIDP (Qualified Infectious Disease Product) designation.
  • Global AMR action plans: WHO’s Global Action Plan emphasizes prudent antibiotic use, potentially constraining sales unless aligned with stewardship programs.

Key Market Segmentation and Geography

Region Market Size (USD, 2022) Growth Outlook Key Factors
North America 1.2 billion 5% CAGR High resistance rates, pricing pressure
Europe 1.0 billion 4.5% Strict regulation, stewardship policies
Asia-Pacific 800 million 7% Large infectious disease burden, emerging middle class
Latin America 500 million 6.5% Increasing healthcare access

What Are the Risks and Opportunities?

Risks:

  • Antimicrobial stewardship policies restricting broad-spectrum antibiotics.
  • Patent expiration leading to price erosion.
  • Emerging resistance decreasing drug efficacy over time.
  • Manufacturing disruptions impacting supply.

Opportunities:

  • Expanding indications into new infection types.
  • Strategic alliances with regional manufacturers.
  • Development of combination therapies against multi-resistant strains.
  • Participation in global AMR initiatives to enhance market presence.

Key Takeaways

  • The demand for DORIDEN is driven by the global surge in antimicrobial resistance, particularly against CRE and other resistant bacteria.
  • Its financial trajectory is favorable, with projected revenues reaching nearly USD 670 million by 2030, assuming market expansion and utilization.
  • Competitive pressures, patent cliff effects, and antimicrobial stewardship policies necessitate strategic innovation and market diversification.
  • Emerging markets and regulatory incentives represent significant growth avenues.
  • The evolving landscape calls for continuous R&D investment, supply chain resilience, and alignment with global health policies.

Frequently Asked Questions

1. What is the current patent status of DORIDEN?

DORIDEN’s primary patents began expiring around 2025 in key markets, paving the way for generic entrants, which could impact pricing and market share.

2. How does DORIDEN differentiate itself from other carbapenems?

DORIDEN exhibits activity against certain resistant strains not fully covered by other carbapenems, offering broader efficacy in multidrug-resistant infections, especially in hospital settings.

3. What are the main barriers to DORIDEN’s widespread adoption?

Barriers include competition from established brands like meropenem and imipenem, cost constraints, regulatory restrictions, and antimicrobial stewardship policies aiming to limit broad-spectrum antibiotic use.

4. What regions offer the most growth potential for DORIDEN?

Emerging markets in Asia-Pacific, Latin America, and expanding healthcare infrastructures in Africa are promising, alongside regulatory incentives in North America and Europe.

5. What strategies should manufacturers pursue to maximize DORIDEN’s market potential?

Key strategies include investing in resistance-focused R&D, forming regional manufacturing alliances, expanding indications, engaging in stewardship-compatible use policies, and leveraging global health initiatives.


References

[1] WHO. Global Antimicrobial Resistance Surveillance System (GLASS). 2021.
[2] U.S. Food and Drug Administration. DORIDEN (doripenem) drug approval documentation. 2007.
[3] MarketWatch. Antibiotic Market Outlook 2023–2030. 2023.


This comprehensive analysis aims to inform strategic investment decisions and forecast DORIDEN’s role within the evolving antimicrobial landscape.

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