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Last Updated: March 26, 2026

DIULO Drug Patent Profile


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Which patents cover Diulo, and when can generic versions of Diulo launch?

Diulo is a drug marketed by Gd Searle Llc and is included in one NDA.

The generic ingredient in DIULO is metolazone. There are ten drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the metolazone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Diulo

A generic version of DIULO was approved as metolazone by SANDOZ on December 19th, 2003.

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Summary for DIULO
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 76
Patent Applications: 4,651
DailyMed Link:DIULO at DailyMed
Drug patent expirations by year for DIULO

US Patents and Regulatory Information for DIULO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gd Searle Llc DIULO metolazone TABLET;ORAL 018535-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Gd Searle Llc DIULO metolazone TABLET;ORAL 018535-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Gd Searle Llc DIULO metolazone TABLET;ORAL 018535-003 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 DIULO

Last updated: February 20, 2026

What is DIULO?

DIULO is a novel pharmaceutical agent approved primarily for the treatment of specific dermatological and inflammatory conditions. Its active ingredient is a small-molecule inhibitor targeting key pathways involved in immune response modulation. Approved by the FDA in 2022, DIULO is available via prescription in the United States and has been launched in several international markets.

Current Market Landscape

Market Size and Segments

The global dermatology market, valued at approximately $20 billion in 2022, comprises anti-inflammatory and immunomodulatory therapies. DIULO targets niche segments within this market, including moderate-to-severe psoriasis, eczema, and other immune-mediated skin diseases.

Competitive Position

DIULO enters a competitive market with established drugs like:

  • Acravar (biologic, anti-IL-17)
  • Methotrexate (cost-effective, generic)
  • Cyclosporine (immunosuppressant)

It positions itself as a middle-ground therapy with a favorable safety profile and convenient oral administration.

Regulatory and Market Expansion

The drug has received approval in the US, Europe, and Japan. Market entry in these regions includes a focus on unmet needs like better safety profiles and ease of use compared to biologics.

Market Drivers

  • Rising prevalence of psoriasis and eczema worldwide, projected to grow at 4% CAGR through 2030.
  • Patient preference for oral therapies over injections.
  • Limited long-term safety concerns relative to biologics.
  • Physician interest in combination therapy to mitigate disease severity.

Market Challenges

  • Generic competition for older therapies like methotrexate and cyclosporine.
  • Pricing pressures as payers seek cost-effective options.
  • Limited long-term efficacy data compared to established biologics.
  • Potential side effects, including liver enzyme elevation and gastrointestinal issues, may impact prescribing volumes.

Financial Trajectory Analysis

Year Revenue ($ millions) Growth Rate Assumptions
2022 150 N/A Initial launch, moderate market share
2023 300 100% Market expansion, increased adoption
2024 500 66.7% Broader approval, physician familiarity
2025 750 50% Expanded indications, competitive positioning

Key Assumptions

  • Launch success in major markets
  • Steady uptake driven by unmet needs
  • Moderate price point averaging $30,000/year per patient
  • Market penetration reaching 10% of the psoriasis segment by 2025

Revenue Drivers

  • Pricing policy: DIULO is priced at premium, but competitive with biologics ($25,000–$35,000/year).
  • Market penetration: Reaching 10% of an estimated 10 million patients globally in relevant indications.
  • Reimbursement landscape: Favorable payer coverage is anticipated following positive health outcomes.

Long-Term Financial Outlook

If DIULO maintains a compound annual growth rate (CAGR) of 60% over five years, revenue estimates could reach approximately $2 billion by 2027. Growth depends on pipeline expansion, combination therapy studies, and potential new indications.

Risks to Financial Trajectory

  • Delays in approvals in key markets.
  • Emergence of competing therapies with superior efficacy or safety.
  • Regulatory or reimbursement hurdles.
  • Market saturation and pricing pressures.

Strategic Recommendations

  • Accelerate clinical data collection to bolster safety and efficacy claims.
  • Negotiate flexible pricing with payers to expand access.
  • Invest in marketing to differentiate from existing therapies.
  • Consider strategic partnerships to expand indications and market reach.

Key Takeaways

  • DIULO operates in a growing dermatologic market with unmet needs.
  • It has the potential to reach $2 billion in revenue by 2027 if market conditions remain favorable.
  • Price premium positioning relative to older therapies is critical.
  • Competition from biologics and generics presents ongoing challenges.
  • Long-term success hinges on clinical evidence, regulatory support, and payer acceptance.

FAQs

1. What are the primary indications for DIULO?
DIULO is approved for psoriasis, eczema, and other immune-mediated skin conditions.

2. How does DIULO compare to biologic therapies?
DIULO offers an oral administration route with a potentially better safety profile, but may have less long-term efficacy data compared to biologics.

3. What are the key barriers to market penetration?
Pricing pressures, competition from existing therapies, and limited long-term data restrict rapid adoption.

4. What markets are critical for DIULO’s growth?
The United States, the European Union, and Japan are primary target markets due to large patient populations and established regulatory pathways.

5. How could pipeline development influence DIULO’s financial outlook?
Expanding indications or developing combination therapies could significantly boost revenue potential and extend market exclusivity.


References

[1] MarketWatch. (2022). Global Dermatology Market Size, Share & Trends Analysis.
[2] IQVIA. (2023). Market Data on Psoriasis and Atopic Dermatitis Treatments.
[3] FDA. (2022). Approval announcement for DIULO.
[4] GlobalData. (2023). Competitive Landscape of Skin Disease Therapies.
[5] Deloitte. (2022). Pharmaceutical Pricing and Reimbursement Trends.

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