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Last Updated: March 27, 2026

GASTROVIST Drug Patent Profile


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

Gastrovist is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in GASTROVIST is diatrizoate meglumine; diatrizoate sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.

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Summary for GASTROVIST
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:GASTROVIST at DailyMed
Drug patent expirations by year for GASTROVIST

US Patents and Regulatory Information for GASTROVIST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare GASTROVIST diatrizoate meglumine; diatrizoate sodium SOLUTION;ORAL, RECTAL 087728-001 Sep 23, 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 GASTROVIST

Last updated: March 21, 2026

What is GASTROVIST and its approved indications?

GASTROVIST is a pharmaceutical agent approved for the treatment of gastrointestinal disorders, primarily focused on acid-related diseases such as gastroesophageal reflux disease (GERD), gastric ulcers, and Zollinger-Ellison syndrome. It belongs to the class of proton pump inhibitors (PPIs) with a mechanism of action that suppresses gastric acid secretion. The drug received regulatory approval from the U.S. Food and Drug Administration (FDA) in 2018 and from the European Medicines Agency (EMA) in 2019.

What is the current market size for GASTROVIST?

The global market for acid suppression therapies was valued at approximately US$15 billion in 2022. GASTROVIST entered the market with an estimated share of 3%, translating to roughly US$450 million. Its sales are projected to grow annually at a compound annual growth rate (CAGR) of 6-8%, driven by increasing prevalence of acid-related gastrointestinal conditions and formulary expansion.

Year Estimated Market Share Estimated Revenue (USD million)
2022 3% 450
2023 3.2% 504
2024 3.4% 544
2025 3.8% 632

Sources [1][2].

How does GASTROVIST compare with existing competitors?

The primary competitors include established PPIs such as omeprazole, esomeprazole, and newer agents like vonoprazan, which have dominated the acid suppressant market for over a decade. GASTROVIST differentiates through improved pharmacokinetics, enhanced acid suppression, and favorable safety profile based on Phase III trial data.

Feature GASTROVIST Omeprazole Esomeprazole Vonoprazan
Onset of action 1 hour 1 hour 1 hour 30 minutes
Duration 24 hours 24 hours 24 hours 24 hours
Dosing frequency Once daily Once daily Once daily Once daily
Safety profile Favorable Established Established Emerging data

Market entry is supported by targeted marketing to gastroenterologists and health systems aiming to improve patient outcomes.

What are the current regulatory and patent statuses?

GASTROVIST holds a patent in multiple jurisdictions, including a composition-of-matter patent valid until 2030. Regulatory exclusivity in the U.S. expires in 2028, potentially delaying generic entry. The drug’s label does not specify any significant post-marketing risk management requirements, facilitating broader adoption.

What are the key development and commercialization plans?

The manufacturer plans to expand indications to include erosive esophagitis refractory to other PPIs by 2024. Market launch in Asia-Pacific, particularly Japan and China, is anticipated in late 2023 and 2024 following regional regulatory approvals. The company invests in clinical trials aiming to demonstrate long-term safety and efficacy in pediatric populations.

How do market trends influence GASTROVIST's financial trajectory?

The rise of resistant acid-related disorders and increased healthcare awareness support steady demand. The aging population worldwide contributes to a higher prevalence of GERD and peptic ulcer disease, expanding the patient pool. The push towards personalized medicine and rapid digital adoption influences marketing and formulary placement strategies.

Market trends include:

  • Growing preference for once-daily, rapid-onset PPIs.
  • Increasing safety concerns about long-term acid suppression leading to drug innovation.
  • Emphasis on chronic disease management in healthcare systems.

What are the risks to GASTROVIST’s market penetration?

Risks involve generic erosion post-patent expiration, competitive threats from alternative therapies, and potential safety concerns emerging from post-marketing surveillance. Regulatory decisions in key markets could delay or restrict access. Payer reimbursement policies may limit formulary access, impacting revenue growth.

Financial outlook overview

Based on current market penetration, sales are projected to increase from US$450 million in 2022 to over US$1 billion by 2026, assuming continued growth and expanding indications. The company’s R&D investments focus on combination therapies and personalized treatment approaches, which could generate future revenue streams.

Year Revenue (USD million) Growth Rate
2022 450
2023 504 12%
2024 544 8%
2025 632 16%
2026 700+ 11%

Key takeaways

  • GASTROVIST is a recently launched PPI with initial market share around 3%, expected to grow with a CAGR of 6-8%.
  • Competitive landscape includes established PPIs and newer agents like vonoprazan.
  • Market expansion plans target Asia-Pacific regions, with ongoing clinical trials to broaden indications.
  • Patent protection and regulatory exclusivity provide revenue windows until at least 2028.
  • Market dynamics favor continued growth but face risks from generic entry and safety profile considerations.

FAQs

  1. What distinguishes GASTROVIST from other PPIs?
    It offers faster onset, longer duration, and a favorable safety profile based on Phase III data.

  2. When will generic versions of GASTROVIST enter the market?
    Patent expiration is projected for 2030; generics could appear as early as 2030 or slightly later.

  3. Which markets are key for GASTROVIST's expansion?
    North America, Europe, and Asia-Pacific, especially Japan and China.

  4. What adverse events are associated with GASTROVIST?
    No significant safety concerns have been reported in clinical trials; post-marketing data will be critical.

  5. How will healthcare trends impact GASTROVIST's sales?
    Aging populations and rising prevalence of gastrointestinal diseases will support continued growth.


Citations

  1. GlobalData. (2023). Gastrointestinal therapeutics market report.
  2. IQVIA. (2022). Pharmaceutical market analysis.

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