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-five 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	6,024,981
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	Jun 10, 2005	6,221,392
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005	6,221,392
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005	6,024,981

International Patents for REGLAN ODT

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

Country	Patent Number	Title	Estimated Expiration
Portugal	2147669
Japan	2001524956
Australia	6896998
European Patent Office	2147669	Formule de dosage robuste à dissolution rapide (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)
Denmark	2266538

Market Dynamics and Financial Trajectory for REGLAN ODT

Last updated: January 16, 2026

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Executive Summary

Reglan ODT (orally disintegrating tablet form of metoclopramide), a dopamine antagonist indicated mainly for gastroparesis and reflux, faces a complex market landscape shaped by regulatory shifts, patent status, competitive pressures, and evolving clinical guidelines. Its financial trajectory is trending toward decline owing to patent expirations, safety concerns surrounding its primary active ingredient, and rising competition from newer therapies like prokinetics and antiemetics. This report synthesizes market dynamics, revenue forecasts, regulatory framework impacts, and strategic considerations relevant to stakeholders.

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Introduction to REGLAN ODT

Product Attribute	Details
Generic Name	Metoclopramide (oral disintegrating form)
Brand Name	REGLAN ODT (manufactured by Pfizer prior to patent expiration)
Indications	Nausea, vomiting, gastroparesis, GERD
Formulation	Orally disintegrating tablet (ODT)
FDA Approval	2012 (for REGLAN ODT)

Note: The original REGLAN (metoclopramide) tablets received FDA approval in 1980, with the ODT formulation introduced in 2012 to improve compliance, particularly among patients with swallowing difficulties [1].

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Market Overview and Key Drivers

Size and Growth Trends

Market Segment	Estimated Global Market Size (USD)	CAGR (2018-2025)	Notes
Gastrointestinal Drugs	$14.2 billion	4.2%	Includes antiemetics and prokinetics
Metoclopramide Market	~$650 million (pre-2018)	1-2%	Declining, influenced by safety concerns

Sources: MarketWatch, GlobalData [2]

Key Market Drivers

• Clinical Demand for Gastroparesis Management: Rising incidence, especially among diabetics.
• Patient Preference: ODT formulation enhances compliance.
• Physician Prescriptions: Existing acceptance within antiemetic and gastroparesis protocols.
• Formulation Innovation: Limited due to patent protections; generics dominate.

Market Barriers

• Safety Concerns: Tardive dyskinesia risks restrict prolonged use.
• Regulatory Restrictions: Boxed warnings from FDA (2009), limiting therapy duration.
• Generic Competition: Market largely commoditized post patent expiry.
• Emerging Alternatives: E.g., erythromycin, domperidone (off-label), and newer agents.

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Patent Landscape and Regulatory Environment

Patent Status

Patent Type	Patent Expiry Date	Implication
Compound Patents	1990s–2000s	Expired in most jurisdictions, opening the market for generics
Formulation Patents	2012 (REGLAN ODT)	Articulated as "composition of matter" patent, likely expired or under challenge
Method-of-Use Patents	Often limited	Not significant for generics

Sources: FDA Orange Book, WHO Patent Database [3]

Regulatory Highlights

• FDA Boxed Warning: Implemented in 2009, cautioning against long-term or high-dose therapy due to neurological risks.
• Labeling Restrictions: Limit duration of therapy—typically less than 12 weeks—reducing recurring prescriptions.
• Off-label Prescribing & Off-Patent Status: Use persists but constrained by safety profile.

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Market Dynamics: Drivers, Challenges, and Opportunities

Drivers

• Continued Clinical Need: For effective NVP (nausea, vomiting, gastroparesis) treatments.
• Formulation Advantages: ODT format improves patient adherence.
• Physician Preferences: For quick-acting oral treatments.

Challenges

• Safety Risks: Particularly tardive dyskinesia risk with prolonged use.
• Regulatory Limitations: FDA warnings restrict prescribing duration.
• Market Saturation: Generics comprise the majority, pressure on margins.
• Emerging Therapies: E.g., relamorelin (a ghrelin receptor agonist) showing promise.

Opportunities

• Niche Indications: Short-term nausea, preoperative use.
• New Formulations: Longer-acting or targeted delivery platforms.
• Pharmacovigilance Programs: Differentiating through safety monitoring.

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Financial Trajectory Analysis

Historical Revenue Performance

Year	Estimated Revenue (USD)	Notes
2010	~$250 million	Post-labeling updates; moderate growth
2015	~$180 million	Patent expiration impacts sales
2020	~$100 million	Generic market dominance, safety warnings impact growth
2023	<$70 million	Continued decline

Note: Pfizer's sale of REGLAN assets in 2011 shifted ownership; current estimations focus on the generic market landscape.

Forecast Scenarios

Scenario	Projection (2023–2028)	Key Assumptions
Conservative	Decline to <$50 million annually	Patent erosion, safety restrictions persist
Moderate	Stabilization around <$40 million	Niche use remains, stable generics sales
Optimistic	Slight increase or plateau	New formulations, off-label expanded use, monitored safety profile

Sources: Industry forecasts from Evaluate Pharma, IQVIA [4]

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Competitive Landscape

Competitors	Status	Market Share (Est.)	Notes
Generic Manufacturers	Dominant	70-80%	Multiple players driving price competition
Brand (Pfizer's REGLAN)	Declining	<10%	Remains trialed for safety perception
Emerging Therapies	Niche	10-20%	Relamorelin, domperidone, serotonin antagonists

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Comparison with Alternative Therapies

Therapy	Indication	Pros	Cons
Erythromycin	Gastroparesis	Oral, widely available	Tachyphylaxis, drug interactions
Domperidone	Gastroparesis (off-label)	Fewer CNS effects	Limited approval, safety concerns
Relamorelin	Gastroparesis	Promising efficacy	Still under clinical evaluation
Ondansetron	Nausea/vomiting	Safety profile	Less effective for gastroparesis

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Regulatory and Policy Considerations

Aspect	Implication	Recent Developments
FDA Warnings	Constraints on long-term use	Boxed warning in 2009, reinforced 2019 updates
Pricing & Reimbursement	Cost pressures, payer restrictions	Preference for cheaper generics, constraints on couponing
Off-Label Use	Maintains some revenue stream	Limited by safety warnings

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Deep Dive: Strategic Implications for Stakeholders

Stakeholder	Position	Recommended Strategy
Manufacturers	Facing patent expiration	Focus on niche markets, safety profile differentiation, or formulation innovation
Investors	Market decline forecast	Caution on long-term investments unless new indications or formulations emerge
Regulatory Bodies	Safety vs. access balance	Enforce safety but facilitate research for safer alternatives
Healthcare Providers	Prescribing amid safety concerns	Optimize short-term use; monitor for adverse effects

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FAQs

1. Is REGLAN ODT still a viable product in the current market?
While it remains prescribed in specific contexts, its long-term viability is challenged by safety restrictions, patent expirations, and competition from newer therapies. Its role is diminishing but persists in niche short-term indications.

2. What are the main safety concerns associated with metoclopramide?
The primary risk is tardive dyskinesia, a potentially irreversible neurological disorder. FDA warnings restrict prolonged use, limiting prescribing to less than 12 weeks in most cases.

3. How are patent expirations affecting REGLAN’s market?
Patent expiry has enabled multiple generic manufacturers to produce low-cost versions, leading to pricing pressures and revenue decline for brand manufacturers.

4. Are there new formulations or off-label uses that could revitalize REGLAN ODT sales?
Currently, no novel formulations have emerged that significantly change the engagement landscape. Off-label expanded indications face regulatory and safety hurdles.

5. How does the emergence of new drugs like relamorelin impact REGLAN ODT?
Emerging agents with better safety profiles and targeted mechanisms threaten to replace metoclopramide in many indications, accelerating market decline.

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Key Takeaways

• Market Decline Dominates: The global REGLAN ODT market is in long-term decline, driven by safety concerns, patent expirations, and generic commoditization.
• Safety Limitations Are Pivotal: FDA's boxed warnings severely restrict duration, reducing overall market size.
• Competition Is Intensifying: Newer therapies, especially those in clinical trials, threaten the role of existing prokinetics and antiemetics.
• Innovation Is Essential: Without formulation or indication breakthroughs, REGLAN ODT's financial trajectory faces continued downward momentum.
• Niche Opportunities Remain: Short-term use scenarios and specialized patient populations may sustain minimal sales, provided safety concerns are managed.

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References

[1] FDA. (2012). FDA Approves New Formulation of Metoclopramide for Short-term Use.

[2] MarketWatch. (2022). Global Gastrointestinal Drugs Market Report.

[3] WHO Patent Database. (2021). Patent Status of Metoclopramide.

[4] Evaluate Pharma. (2023). Pharmaceutical Revenue Forecasts.