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

International Patents for GASTROMARK

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

Country	Patent Number	Title	Estimated Expiration
Spain	2059299
Japan	H01500196
Denmark	237484
Japan	2683786

GASTROMARK Market Analysis and Financial Projection Experimental

GastroMark: Understanding Market Dynamics and Financial Trajectory

Introduction

GastroMark, a diagnostic aid for gastric emptying, has been a part of the pharmaceutical landscape, particularly in the context of gastric motility disorders. To understand its market dynamics and financial trajectory, it is essential to delve into the broader market trends, regulatory environments, and the strategies of pharmaceutical companies involved.

Market Context of Gastric Motility Disorders

The gastric motility disorder drug market is experiencing significant growth, driven by increasing prevalence of gastric disorders globally. This market is estimated to be valued at USD 57.65 billion in 2024 and is projected to reach USD 83.15 billion by 2031, growing at a CAGR of 5.4% from 2024 to 2031[1].

Historical Overview of GastroMark

GastroMark was marketed and sold under the trade name by AMAG Pharmaceuticals, Inc. However, detailed financial and market performance data specifically for GastroMark are not as readily available as those for other products like Feraheme, which was a major revenue generator for AMAG Pharmaceuticals[4].

Market Dynamics

Regulatory Environment

The pharmaceutical industry, including products like GastroMark, is heavily regulated. Changes in regulatory environments can significantly impact the market dynamics. For instance, AMAG Pharmaceuticals had to adjust its strategies based on FDA regulations and post-marketing data, which can affect the commercial viability of products[2][4].

Competitive Landscape

The market for gastric motility disorder drugs is competitive, with major players like Pfizer Inc. and Takeda Pharmaceutical Company Limited. The competition is further intensified by the expiry of patents for major drugs, which can lead to the entry of generic competitors and affect the market share of branded products[1].

Distribution Channels

The distribution of gastric motility disorder drugs, including diagnostic aids like GastroMark, is predominantly through retail pharmacies, which hold a significant market share. Retail pharmacies offer convenience and immediate access to medications, which is crucial for patients managing chronic conditions[1].

Financial Trajectory

Revenue Streams

For AMAG Pharmaceuticals, the primary revenue streams were from products like Feraheme and MuGard. While GastroMark was part of their portfolio, it did not contribute as significantly to their overall revenue. The company's focus on expanding its portfolio through the in-license or purchase of additional specialty pharmaceutical products indicates a strategic shift towards more lucrative market segments[4].

Cost Structure and Efficiency

AMAG Pharmaceuticals undertook significant restructuring to align its operating cost structure with its corporate strategy. This included reducing the workforce and focusing resources on key priorities such as advancing Feraheme and expanding the product portfolio. Such measures suggest that the company was optimizing its financial resources to focus on more profitable ventures[5].

Strategic Acquisitions and Partnerships

The acquisition of Lumara Health by AMAG Pharmaceuticals for approximately $600 million and the potential for future contingent payments highlights the company's strategy to expand its portfolio and leverage its commercial infrastructure. This approach indicates a focus on high-revenue and high-growth segments, which might have overshadowed the financial trajectory of products like GastroMark[2].

Challenges and Opportunities

Lack of Curative Options

One of the major challenges in the gastric motility disorder drug market is the lack of curative options and limited treatment efficacy of existing drugs. This presents an opportunity for companies to invest in research and development to create novel and advanced treatments, which could include diagnostic aids like GastroMark[1].

Emerging Technologies

Emerging technologies such as drug delivery using gastric retainable systems offer opportunities to overcome issues with poor drug absorption and retention. This could be a promising area for the development of new treatments and diagnostic tools, potentially reviving interest in products like GastroMark[1].

Regional Market Dynamics

North America

North America, particularly the U.S., is a dominant region in the gastric motility disorder drug market, driven by a strong pharmaceutical industry presence and significant investments in clinical research and drug development. This region's market dynamics could influence the financial trajectory of products like GastroMark, although specific data is limited[1].

Asia Pacific

The Asia Pacific region is emerging as the fastest-growing market, driven by the rising geriatric population and increasing cases of functional gastrointestinal disorders. This growth presents opportunities for pharmaceutical companies to expand their market presence, although it may not directly impact the financial trajectory of a specific product like GastroMark unless it is part of a broader strategic expansion[1].

Key Takeaways

• The gastric motility disorder drug market is growing, driven by increasing prevalence and advancements in treatment options.
• Regulatory changes and competitive pressures significantly impact the market dynamics.
• Retail pharmacies are the dominant distribution channel for gastric motility disorder drugs.
• AMAG Pharmaceuticals focused on optimizing its cost structure and expanding its portfolio towards more lucrative segments.
• Emerging technologies and regional market growth present opportunities for new treatments and diagnostic tools.

FAQs

What is the current market size of the gastric motility disorder drug market?

The gastric motility disorder drug market is estimated to be valued at USD 57.65 billion in 2024[1].

What is the projected growth rate of the gastric motility disorder drug market?

The market is expected to grow at a CAGR of 5.4% from 2024 to 2031[1].

Which region dominates the gastric motility disorder drug market?

North America, particularly the U.S., dominates the market with a significant presence of pharmaceutical companies and investments in clinical research[1].

What are the main challenges in the gastric motility disorder drug market?

The main challenges include the lack of curative options, limited treatment efficacy, and the expiry of patents for major drugs[1].

How do emerging technologies impact the gastric motility disorder drug market?

Emerging technologies like drug delivery using gastric retainable systems offer opportunities to overcome issues with poor drug absorption and retention, potentially leading to the development of novel treatments[1].

Sources

1. Coherent Market Insights: Gastric Motility Disorder Drug Market Size & Share Analysis.
2. Annual Reports: AMAG Pharmaceuticals, Inc. - Annual Reports.
3. The Commonwealth Fund: Competition, Consolidation, and Evolution in the Pharmacy Market.
4. Annual Reports: AMAG Pharmaceuticals, Inc. - Annual Reports (2013).
5. FiercePharma: AMAG Pharmaceuticals Realigns Operating Cost Structure to Focus on Continued Feraheme.