REGLAN ODT Drug Patent Profile

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

Reglan Odt is a drug marketed by Meda Pharms and is included in one NDA.

The generic ingredient in REGLAN 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 Reglan Odt

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

Summary for REGLAN ODT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	35
Patent Applications:	1,111
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REGLAN ODT
DailyMed Link:	REGLAN ODT at DailyMed

Recent Clinical Trials for REGLAN ODT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mercy Health System	Phase 4
Women and Infants Hospital of Rhode Island	Phase 2
Emory University	Phase 4

See all REGLAN ODT clinical trials

US Patents and Regulatory Information for REGLAN ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	Jun 10, 2005		DISCN	No	No
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005		DISCN	No	No

Expired US Patents for REGLAN ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	Jun 10, 2005
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	Jun 10, 2005

International Patents for REGLAN ODT

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

Country	Patent Number	Title	Estimated Expiration
Denmark	2266538
Australia	726336
European Patent Office	2147669	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)
Canada	2284663	DISSOLUTION RAPIDE DE FORME POSOLOGIQUE DE BONNE TENUE (RAPIDLY DISSOLVING ROBUST DOSAGE FORM)
World Intellectual Property Organization (WIPO)	9846215
European Patent Office	2266538	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)

Market Dynamics and Financial Trajectory for REGLAN ODT

Last updated: July 28, 2025

Introduction

REGLAN ODT (Metoclopramide Oral Disintegrating Tablet) is a formulation of a well-established gastroprokinetic and antiemetic drug, primarily used to treat nausea, vomiting, and gastroparesis. Its unique oral disintegrating tablet format caters to patients with swallowing difficulties and enhances patient compliance. Understanding the market dynamics and financial trajectory of REGLAN ODT requires analyzing its therapeutic landscape, competitive positioning, regulatory environment, and evolving market trends.

---

Market Overview

Therapeutic Indications and Clinical Positioning

REGLAN ODT contains metoclopramide, approved for indications such as diabetic gastroparesis, chemotherapy-induced nausea, and postoperative nausea. Its efficacy in augmenting gastric motility has cemented its role in gastrointestinal therapeutics. However, safety concerns related to neurological side effects, such as tardive dyskinesia, influence prescribing practices (FDA [1]).

Market Penetration and Adoption

The oral disintegrating tablet format addresses a niche segment—patients with dysphagia or those requiring rapid onset. This formulation enhances patient adherence, especially among pediatric and geriatric populations. While the original REGLAN has faced limitations due to safety warnings, the ODT variant has gained traction as a preferable alternative.

Competitive Landscape

REGLAN ODT competes with other antiemetics and prokinetics, including ondansetron, domperidone, and newer agents with better safety profiles. The rise of serotonin antagonists like ondansetron, which offers a more favorable side effect profile, has affected REGLAN's market share. Nonetheless, REGLAN's cost-effectiveness and established efficacy sustain its relevance, especially in regions with limited access to newer drugs.

---

Regulatory and Safety Considerations

FDA Warnings and Restrictions

The U.S. Food and Drug Administration (FDA) strongly advised against long-term or high-dose use of metoclopramide due to risks of neurological adverse effects, particularly tardive dyskinesia, making prescribers cautious and impeding growth prospects in North America. Consequently, the product’s use is now limited, affecting its market volume [1].

Global Regulatory Environment

In contrast, some markets outside the U.S., such as Europe and Asia, maintain more permissive regulatory environments. This discrepancy influences regional sales trajectories and availability, enabling REGLAN ODT to maintain a global presence despite restrictions in certain territories.

---

Market Drivers

Growing Gastrointestinal Disorders

The prevalence of gastroparesis and other gastrointestinal motility disorders is rising globally, driven by aging populations and increasing diabetes prevalence. This augments demand for prokinetic agents like REGLAN ODT, especially in regions with a high healthcare burden.

Patient-Centric Formulation Preferences

The ODT format aligns with patient preferences for convenient, non-invasive medication forms, especially amid advancing technology in drug delivery systems. Manufacturers have capitalized on this trend by marketing REGLAN ODT as an easy-to-administer alternative.

Expanding Use in Oncology

Chemotherapy-induced nausea remains a significant clinical issue. REGLAN ODT offers rapid symptomatic relief, making it favorable in oncology settings. As cancer survivorship improves globally, the demand for effective antiemetics is projected to escalate.

---

Market Challenges

Safety and Regulatory Constraints

The primary obstacle to extensive growth is safety-related restrictions. The risks of neurological side effects have led to usage limitations in the U.S., reducing its prescription volume. Reimbursement and prescribing limitations hinder broader adoption.

Emergence of Safer Alternatives

Newer antiemetics with better safety profiles, such as NK-1 receptor antagonists and 5-HT3 antagonists, threaten REGLAN ODT’s market share. Their increasing adoption, especially in developed markets, curtails revenue prospects.

Patent and Commercial Competition

Although REGLAN is a generic product, patent expiry and price competition have pressured profit margins. Manufacturers face challenges in distinguishing REGLAN ODT amid a crowded generic landscape.

---

Financial Trajectory and Market Projections

Current Revenue Trends

In mature markets like the U.S., sales of REGLAN ODT have plateaued or declined, consistent with regulatory and safety concerns. Conversely, in emerging markets with less restrictive regulations, sales figures remain stable or show modest growth.

Future Market Opportunities

• Emerging Markets: Countries with less restrictive regulations and increasing gastrointestinal disorder prevalence present untapped growth opportunities.
• Specialty Applications: Development of targeted formulations for specific patient populations, like pediatric or elderly cohorts, could stimulate market expansion.
• Combination Therapies: Co-formulation strategies with other gastrointestinal agents may enhance therapeutic efficacy and market appeal.

Forecast Outlook (2023-2030)

Analysts project a cautious upward trajectory in select markets—mostly driven by non-U.S. regions—due to demographic shifts, expanding indications, and formulation advantages. However, broader growth is contingent on regulatory relaxations, safety profile improvements, or new formulations with reduced adverse effects [2].

---

Strategic Considerations for Stakeholders

• Manufacturers should prioritize market segmentation strategies, focusing on regions with supportive regulatory landscapes.
• Pharmaceutical developers might invest in reformulating REGLAN to mitigate safety risks or explore novel delivery methods.
• Investors should monitor regulatory developments and regional growth indicators, balancing opportunities in emerging markets against mature market stagnation.

---

Key Takeaways

• Regulatory Constraints: Safety concerns substantially limit REGLAN ODT’s growth in mature markets, especially the U.S., dictating a cautious business outlook.
• Regional Variability: Differing regulatory environments shape global sales, benefiting markets with fewer restrictions and higher disease prevalence.
• Competition Dynamics: The antiemetics landscape is increasingly crowded with safer, newer agents, challenging REGLAN ODT’s market share.
• Market Potential: Growing gastrointestinal disorders and patient preferences for convenient formulations underpin strategic growth opportunities, particularly in emerging markets.
• Innovation Needs: To sustain or enhance financial trajectories, stakeholders must innovate—either through reformulation, targeted indications, or combination therapies.

---

FAQs

1. What are the primary safety concerns associated with REGLAN ODT?
Metoclopramide, the active ingredient in REGLAN, has been linked to neurological adverse effects such as tardive dyskinesia, especially with long-term or high-dose use. These concerns led the FDA to restrict its usage, influencing prescribing patterns.

2. How does REGLAN ODT compare to newer antiemetics like ondansetron?
While REGLAN offers prokinetic benefits, ondansetron provides antiemetic activity with a more favorable safety profile, making it more popular in many markets. REGLAN’s safety limitations have reduced its dominance.

3. What regional factors influence REGLAN ODT’s market performance?
Regulatory restrictions, prevalence of gastrointestinal disorders, healthcare infrastructure, and clinician familiarity shape regional market performance. Countries with limited regulatory oversight or higher disease prevalence may see steadier demand.

4. Are there ongoing efforts to mitigate REGLAN’s safety risks?
Research initiatives aim to reformulate or develop safer alternatives. However, no major reformulation has yet replaced current formulations, and safety concerns continue to restrict its use.

5. What strategic moves should pharmaceutical companies consider?
Investing in reformulation to reduce side effects, expanding indications, focusing on emerging markets, and developing combination therapies are vital for maintaining relevance and growth.

---

References

[1] FDA Drug Safety Communication. Tardive Dyskinesia and Metoclopramide Use. 2019.
[2] Market Research Future. Global Gastrointestinal Drugs Market Analysis. 2022.