METOZOLV ODT Drug Patent Profile

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

Metozolv Odt is a drug marketed by Salix Pharms and is included in one NDA.

The generic ingredient in METOZOLV ODT is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Metozolv Odt

A generic version of METOZOLV ODT was approved as metoclopramide hydrochloride by TEVA on July 29^th, 1985.

Summary for METOZOLV ODT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	61
Patent Applications:	1,111
DailyMed Link:	METOZOLV ODT at DailyMed

Paragraph IV (Patent) Challenges for METOZOLV ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
METOZOLV ODT	Orally Disintegrating Tablets	metoclopramide hydrochloride	5 mg and 10 mg	022246	1	2010-08-24

US Patents and Regulatory Information for METOZOLV ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-001	Sep 4, 2009		DISCN	Yes	No
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-002	Sep 4, 2009		DISCN	Yes	No

Expired US Patents for METOZOLV ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-001	Sep 4, 2009	6,413,549
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-002	Sep 4, 2009	6,413,549

International Patents for METOZOLV ODT

See the table below for patents covering METOZOLV ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2001509478
Japan	4943581
Australia	8399298
World Intellectual Property Organization (WIPO)	9902140

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: METOZOLV ODT

Last updated: July 27, 2025

Introduction

Metozolv ODT, marketed as Metoclopramide orally disintegrating tablets, is a prescription antiemetic and prokinetic agent primarily used to treat nausea, vomiting, and gastroparesis. As a unique formulation designed for rapid disintegration in the oral cavity, Metozolv ODT has carved out niche applications within gastrointestinal disorder management. Its market performance and financial prospects are influenced by a complex interplay of factors including regulatory status, competitive landscape, prescribing trends, and emerging therapies.

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Regulatory and Patent Landscape

The regulatory pathway for Metozolv ODT has been well-established, with approval by the U.S. Food and Drug Administration (FDA) granted decades ago, reflecting its safety and efficacy profile. However, the expiry of key patents, particularly for specific formulations, has opened the market to generic entrants, intensifying price competition. The absence of exclusivity in many markets diminishes barriers to entry, affecting revenue streams for brand-name developers.

In addition, potential regulatory challenges related to metoclopramide’s safety concerns—particularly with long-term use—pose risks for market stability. The FDA has issued black box warnings citing risks of tardive dyskinesia, which might influence prescriber behavior and reimbursement policies[[1]].

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Market Size and Key Drivers

The global antiemetic drug market was valued at approximately USD 7.2 billion in 2021 and is projected to reach USD 9.8 billion by 2026, growing at a CAGR of approximately 6%. A significant slice of this growth emanates from the gastrointestinal segment, where agents like Metozolv ODT contribute.

The demand for Metozolv ODT hinges on several key drivers:

• Patient Convenience and Compliance: The orally disintegrating formulation enhances patient adherence, especially among pediatric and geriatric populations who have difficulty swallowing pills.

• Increasing Prevalence of Nausea and Gastroparesis: Rising incidences of diabetic gastroparesis and chemotherapy-induced nausea elevate demand. The CDC estimates over 34 million Americans with diabetes, many experiencing gastroparesis symptoms[[2]].

• Growth in Oncology and Postoperative Care: The expanding use of chemotherapy regimens requiring antiemetics sustains steady prescriptions.

• Innovation and Formulation Enhancements: Development of new delivery systems that improve drug efficacy and reduce side effects can sustain or augment market share.

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Competitive Landscape

Metozolv ODT faces competition from both branded and generic formulations of metoclopramide, as well as alternative antiemetic agents such as ondansetron, granisetron, and other 5-HT3 receptor antagonists.

Key competitors include:

• Generic Manufacturers: Multiple companies produce generic metoclopramide tablets, significantly impacting pricing strategies. The price erosion caused by generics has resulted in a 30-50% decline in revenue for branded formulations over the past five years[[3]].

• Alternative Therapeutics: Newer agents like %Ondansetron and NK1 receptor antagonists are increasingly preferred for specific indications, influencing market share dynamics.

• Emerging Therapies: Novel prokinetic agents and targeted biologics under research may further disrupt the space, potentially impacting long-term sales for existing drugs.

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Market Challenges

Despite its established role, Metozolv ODT’s growth is constrained by several challenges:

• Safety Concerns: Long-term or high-dose use is associated with neurological adverse events, necessitating cautious prescribing and potentially limiting usage.

• Regulatory Restrictions: Increased risk warnings lead to prescribing restrictions, especially in vulnerable populations, reducing utilization rates.

• Pricing Pressures: The rise of generics and payor-driven formulary management limits profit margins for brand-name drugs.

• Limited Innovation: The slow pipeline of new formulations or indications for metoclopramide hampers growth prospects.

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Financial Trajectory and Revenue Projections

Based on current market trends, the financial trajectory for Metozolv ODT is characterized by a declining revenue pattern, primarily driven by patent expirations and generic competition. Key indicators include:

• Decreasing Brand Revenue: Since patent cliffs, brand sales have declined by an estimated 45% over the last five years[[3]].

• Generic Surge: Generics now account for over 80% of prescriptions, leading to steep price declines for brand-name versions.

• Market Penetration Strategies: Manufacturers investing in niche indications or patient-centric formulations may stabilize or slightly grow revenues in specialized segments.

• Emerging Opportunities: Expanding into developing markets with fewer regulatory restrictions and rising gastrointestinal disorders could provide moderate growth avenues.

Projections indicate that, without significant innovation or new indications, the annual revenue for Metozolv ODT is likely to decline at a rate of 3-5% over the next five years. Conversely, targeted marketing and formulation enhancements could mitigate declines, especially in emerging markets.

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Future Outlook and Strategic Considerations

The outlook for Metozolv ODT involves navigating a saturated, highly competitive market with safety considerations at the forefront. Companies focusing on lifecycle management—such as exploring new therapeutic indications, combination therapies, or improved delivery systems—may sustain relevance. Additionally, embracing patient-focused marketing and healthcare provider education around appropriate use can help carve out specialty niches.

Regulatory vigilance, especially concerning safety warnings, and pricing strategies will be pivotal. Investment in post-marketing studies to support safety profiles and new indications can bolster long-term viability.

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Key Market Segments and Emerging Trends

• Special Populations: Pediatric and elderly populations remain a critical segment due to compliance advantages of ODT formulations.

• Hospital and Specialty Care: Institutional settings often favor formulations like Metozolv ODT for its ease of administration.

• Global Expansion: Growing healthcare infrastructure and rising gastroenterological issues in Asia-Pacific and Latin America present growth opportunities.

• Digital and Data-Driven Marketing: Leveraging real-world evidence and digital health data can facilitate targeted outreach to prescribers.

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Key Takeaways

• Patent expiry and generic competition have significantly eroded brand revenues, emphasizing the need for lifecycle management strategies.
• Safety warnings related to long-term metoclopramide use influence prescribing patterns and market potential.
• Emerging therapies and alternatives continue to challenge market share, demanding innovation.
• Growing global gastrointestinal disorder prevalence offers incremental growth in developing regions.
• Formulation advantages of Metozolv ODT sustain niche usage, especially among populations with swallowing difficulties.

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Frequently Asked Questions (FAQs)

1. What factors are most affecting the future sales of Metozolv ODT?
   Patent expirations leading to generic competition, safety warnings limiting usage, and competition from newer antiemetic agents are primary factors impacting future sales.

2. Can Metozolv ODT regain market share through new indications?
   Potentially, if novel clinical evidence supports additional uses, regulatory agencies may approve expanded indications, providing growth opportunities.

3. How does safety concern influence prescribing patterns?
   Warnings of tardive dyskinesia and other neurological adverse events often lead clinicians to reserve metoclopramide for short-term or specific cases, reducing overall volume.

4. What strategies can manufacturers use to prolong Metozolv ODT's market relevance?
   Leveraging lifecycle management with new formulations, developing combination therapies, targeting niche markets, and expanding geographic presence are effective strategies.

5. Are there emerging therapies that may replace Metozolv ODT?
   Yes, newer antiemetics and prokinetics with better safety profiles, such as 5-HT3 antagonists or NK1 receptor antagonists, pose significant competition.

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References:

[1] U.S. Food and Drug Administration. (2019). Black Box Warning for Metoclopramide.
[2] Centers for Disease Control and Prevention. (2022). Diabetes Data and Trends.
[3] IQVIA. (2021). Pharmaceutical Market Analysis Reports.