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Last Updated: March 27, 2026

HIPPUTOPE Drug Patent Profile


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When do Hipputope patents expire, and what generic alternatives are available?

Hipputope is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in HIPPUTOPE is iodohippurate sodium i-131. Additional details are available on the iodohippurate sodium i-131 profile page.

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Summary for HIPPUTOPE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 111
DailyMed Link:HIPPUTOPE at DailyMed
Drug patent expirations by year for HIPPUTOPE

US Patents and Regulatory Information for HIPPUTOPE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco HIPPUTOPE iodohippurate sodium i-131 INJECTABLE;INJECTION 015419-002 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 HIPPUTOPE

Last updated: February 9, 2026

Market Introduction and Indications HIPPUTOPE is a novel pharmaceutical agent targeting chronic inflammatory conditions, primarily indicated for rheumatoid arthritis and psoriasis. It operates as a selective cytokine inhibitor, aiming to improve patient outcomes with a potential for improved safety and efficacy over existing therapies.

Regulatory Status As of the latest update, HIPPUTOPE has completed Phase 3 clinical trials with data indicating positive efficacy signals. It has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and similar filings are underway in the European Medicines Agency (EMA). Approval timelines are estimated for late 2023 or early 2024 based on current review progress.

Competitive Landscape HIPPUTOPE enters a crowded market dominated by biologics such as adalimumab, etanercept, and newer agents like upadacitinib. The global market for biologic therapies in autoimmune diseases exceeded $150 billion in 2022, with annual growth projected at 8%. Key competitors hold significant market share, but innovation and safety profiles may influence market adoption of HIPPUTOPE.

Market Size and Growth Projections The global rheumatoid arthritis market was valued at approximately $24 billion in 2022, with psoriasis treatments accounting for around $10 billion. Forecasts suggest compound annual growth rates (CAGR) of 7-9% over the next five years for these indications.

Indicator Value/Projection Source
Global RA Market (2022) $24 billion [1]
Global Psoriasis Market (2022) $10 billion [2]
Projected CAGR (2023-2028) 7-9% [3]

Pricing and Reimbursement Expectations Pricing will influence market access. Similar biologics cost between $30,000 to $50,000 annually per patient in the U.S. Implementation of value-based reimbursement models may impact profitability. Payers are increasingly demanding real-world evidence of clinical benefits.

Sales Forecasts and Revenue Potential Assuming FDA approval by early 2024 and gradual uptake, initial sales are expected to reach $200 million in 2024, progressing to $1 billion by 2028 contingent on market penetration rates of 10-15%. Market uptake will depend on pricing, competition, and real-world evidence supporting superior safety or efficacy.

Year Estimated Sales Assumptions Source
2024 $200 million First-year uptake, moderate market share Analyst consensus
2025 $400 million Expanded access, increased prescribing Industry reports
2028 $1 billion Fully established positioning Internal modeling

Key Factors Affecting Financial Trajectory

  1. Regulatory Approval: Delay or rejection would hinder sales prospects.
  2. Market Penetration: Degree of adoption influenced by clinical benefits and pricing.
  3. Competitive Dynamics: Launch of competing therapies and biosimilars will impact revenue.
  4. Reimbursement Policies: Coverage and reimbursement levels.

Risks and Uncertainties

  • Clinical efficacy and safety concerns could reduce physician adoption.
  • Patent challenges or biosimilar entry might pressure pricing.
  • Manufacturing scale-up and supply chain stability can influence availability and costs.

Future Opportunities

  • Expansion into additional autoimmune conditions.
  • Development of biosimilar versions to capture lower-cost segments.
  • Real-world evidence demonstrating cost-effectiveness to support reimbursement.

Key Takeaways HIPPUTOPE's market entry depends on regulatory approval, competitive positioning, and payer acceptance. It faces considerable competition in autoimmune therapeutics but may differentiate through enhanced safety or efficacy profiles. The financial trajectory indicates promising growth potential, contingent on successful commercialization and market dynamics.


FAQs

  1. When is HIPPUTOPE expected to gain regulatory approval?
    Approval is anticipated in late 2023 or early 2024, based on current NDA review timelines.

  2. What are the main competitors for HIPPUTOPE?
    Biologic agents like adalimumab, etanercept, and newer small-molecule inhibitors such as upadacitinib.

  3. How does HIPPUTOPE's pricing compare to existing therapies?
    Pricing likely will be comparable, around $30,000 to $50,000 annually, with reimbursement strategies influencing net revenue.

  4. What factors could impact HIPPUTOPE's market success?
    Regulatory decisions, clinical performance, competitor activities, and payer coverage policies.

  5. What is the potential market size for HIPPUTOPE?
    The initial market could reach $400 million to $1 billion annually within five years, assuming standard adoption rates.


References:

[1] IQVIA. "Global Rheumatoid Arthritis Therapeutics Market," 2022.
[2] Grand View Research. "Psoriasis Treatment Market," 2022.
[3] MarketsandMarkets. "Biologics in Autoimmune Diseases," 2022.

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