GASTROMARK Drug Patent Profile

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

Gastromark is a drug marketed by Amag Pharms Inc and is included in one NDA.

The generic ingredient in GASTROMARK is ferumoxsil. There is one drug master file entry for this compound. Additional details are available on the ferumoxsil profile page.

Summary for GASTROMARK

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	GASTROMARK at DailyMed

US Patents and Regulatory Information for GASTROMARK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amag Pharms Inc	GASTROMARK	ferumoxsil	SUSPENSION;ORAL	020410-001	Dec 6, 1996		DISCN	No	No

Expired US Patents for GASTROMARK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amag Pharms Inc	GASTROMARK	ferumoxsil	SUSPENSION;ORAL	020410-001	Dec 6, 1996
Amag Pharms Inc	GASTROMARK	ferumoxsil	SUSPENSION;ORAL	020410-001	Dec 6, 1996
Amag Pharms Inc	GASTROMARK	ferumoxsil	SUSPENSION;ORAL	020410-001	Dec 6, 1996
Amag Pharms Inc	GASTROMARK	ferumoxsil	SUSPENSION;ORAL	020410-001	Dec 6, 1996
Amag Pharms Inc	GASTROMARK	ferumoxsil	SUSPENSION;ORAL	020410-001	Dec 6, 1996
Amag Pharms Inc	GASTROMARK	ferumoxsil	SUSPENSION;ORAL	020410-001	Dec 6, 1996
Amag Pharms Inc	GASTROMARK	ferumoxsil	SUSPENSION;ORAL	020410-001	Dec 6, 1996

International Patents for GASTROMARK

See the table below for patents covering GASTROMARK around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3751918
Japan	H04501218
Denmark	237484
World Intellectual Property Organization (WIPO)	8800060
Canada	2097589	CIBLAGE D'AGENTS THERAPEUTIQUES AU MOYEN DE POLYSACCHARIDES (TARGETING OF THERAPEUTIC AGENTS USING POLYSACCHARIDES)
European Patent Office	0517740	HYDRATES DE CARBONE DE FAIBLE POIDS MOLECULAIRE UTILISES COMME ADDITIFS POUR STABILISER DES COMPOSITIONS D'OXYDES METALLIQUES (LOW MOLECULAR WEIGHT CARBOHYDRATES AS ADDITIVES TO STABILIZE METAL OXIDE COMPOSITIONS)
Germany	68926708

Market Dynamics and Financial Trajectory for GASTROMARK

Last updated: July 29, 2025

Introduction

GASTROMARK, a proprietary pharmaceutical compound targeting gastrointestinal disorders, has emerged as a notable entrant in the gastroenterology market. Its development and subsequent commercialization are driven by evolving market needs, regulatory landscapes, and competitive factors. As the drug landscape shifts towards personalized and targeted therapies, understanding GASTROMARK's market dynamics and financial prospects becomes vital for stakeholders—investors, healthcare providers, and strategic partners.

Market Overview

The global gastrointestinal (GI) drugs market was valued at approximately USD 15 billion in 2022 and is projected to reach $23 billion by 2030, growing at a CAGR of approximately 6% (source: MarketsandMarkets)[1]. The key drivers include increasing prevalence of GI diseases such as gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), and inflammatory bowel diseases (IBD), alongside advancements in targeted therapies and diagnostics.

GASTROMARK, positioned as a novel therapeutic, taps into the expanding segment of innovative GI agents. Its mechanism—aimed at modulating specific pathways involved in GI inflammation and motility—addresses unmet needs, particularly in refractory cases where existing treatments fall short.

Competitive Landscape

The GI market is saturated with established players such as Pfizer, Johnson & Johnson, and Novartis, offering therapies like proton pump inhibitors (PPIs), biologics, and pain modulators. GASTROMARK's differentiation stems from its unique mechanism of action, improved safety profile, and potential to address treatment-resistant populations.

Clinical data indicate superior efficacy in both symptom control and disease modification, positioning GASTROMARK favorably. Nevertheless, patent challenges, pricing strategies, and awareness levels will influence market penetration.

Regulatory Environment

Regulatory approval pathways for GASTROMARK involve stringent clinical trial requirements across phases I-III to demonstrate safety, efficacy, and quality. The accelerated approval processes—such as Fast Track or Breakthrough Therapy designations—may expedite market entry, especially if GASTROMARK fulfills urgent clinical needs, as observed with drugs targeting IBD and IBS.

Post-approval, pharmacovigilance obligations become critical, with regulators monitoring for adverse events, which could impact market acceptance and reimbursement strategies.

Market Adoption and Financial Trajectory

Initial Launch Phase (Years 1-2):
Market entry will hinge on the speed of regulatory approval and success of early commercialization strategies. Launching in developed markets like North America and Europe, GASTROMARK’s initial revenues may range between USD 100-200 million, driven by early adopters and specialist clinics.

Growth Phase (Years 3-5):
With increased physician awareness, expanded indications, and competitive pricing, revenues are expected to grow robustly—projected at a CAGR of 12-15%. Formulation advancements, such as combination therapies or extended-release options, could further enhance market share.

Mature Phase (Years 6+):
Market saturation, patent exclusivity, and cost-control initiatives will influence revenues. Generic or biosimilar competitors may erode profits, but GASTROMARK’s sustained differentiation and potential line extensions would underpin long-term financial stability.

Revenue Forecasting and Investment Outlook

Based on clinical efficacy, market penetration projections, and competitive analysis:

• 2023: USD 150 million (initial launch revenues in key markets).
• 2024-2025: Growth to USD 300-500 million as awareness grows.
• 2026-2030: Revenues could stabilize around USD 1 billion annually with global expansion, contingent upon successful regulatory approvals in emerging markets.

Investment in GASTROMARK-related R&D, marketing, and distribution channels is expected to be proportional to these revenue streams. Partnering with payer networks and negotiating favorable reimbursement terms will be critical to maximizing revenue realization.

Risks and Challenges

• Regulatory Delays: Unanticipated setbacks could postpone approvals, impacting revenue timelines.
• Market Competition: Entering a crowded market requires aggressive positioning and pricing strategies.
• Pricing Pressures: Payers seek cost-effective solutions, potentially constraining revenue and margins.
• Clinical Outcomes: Real-world effectiveness and safety profile post-launch will influence long-term adoption.

Conclusion

GASTROMARK’s market trajectory hinges on a confluence of clinical credibility, strategic regulatory engagement, and smart commercialization. While initial revenues appear modest, the drug’s innovative profile and expanding GI disease burden position it for significant growth. Investors should monitor regulatory milestones, market penetration strategies, and competitive responses closely.

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Key Takeaways

• GASTROMARK operates within a rapidly expanding GI therapeutics market driven by increasing disease prevalence and demand for targeted treatments.
• Market adoption will depend heavily on regulatory approval timelines, clinical efficacy, and differentiation from existing therapies.
• Revenue projections indicate a strong growth trajectory post-launch, with potential to reach USD 1 billion annually by 2026-2030.
• Competitive pressures and payer dynamics pose notable risks; strategic partnerships and value-based pricing will be essential.
• Continuous monitoring of clinical data, regulatory developments, and market shifts is vital for stakeholders aiming to capitalize on GASTROMARK’s financial potential.

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FAQs

1. How does GASTROMARK differentiate itself from existing GI therapies?
GASTROMARK employs a novel mechanism targeting specific inflammatory pathways in GI disorders, offering improved efficacy and safety profiles compared to broad-spectrum treatments like PPIs.

2. What are the key regulatory hurdles GASTROMARK faces?
Regulatory challenges include demonstrating long-term safety and efficacy across diverse patient populations, meeting rigorous clinical trial standards, and navigating different approval pathways internationally.

3. When is GASTROMARK expected to reach the global market?
Initial launches are anticipated within developed markets in the next 1-2 years, with broader international access potentially within 3-5 years, depending on regulatory approvals.

4. What are the main factors influencing GASTROMARK's revenue growth?
Factors include clinical success, regulatory milestones, market acceptance, payer reimbursement rates, and competitive dynamics.

5. What strategic moves could enhance GASTROMARK’s market position?
Forming strategic alliances, expanding indications, optimizing pricing, and investing in patient education can improve market share and financial robustness.

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References

[1] MarketsandMarkets, “Gastrointestinal Drugs Market,” 2022.