METOCLOPRAMIDE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for metoclopramide hydrochloride and what is the scope of freedom to operate?

Metoclopramide hydrochloride is the generic ingredient in ten branded drugs marketed by Roxane, Avet Lifesciences, Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Hikma, Actavis Mid Atlantic, Ani Pharms, Chartwell Molecular, Genus, Morton Grove, Paco, Pharmobedient Cnsltg, Teva, Vistapharm Llc, Robins Ah, Evoke Pharma Inc, Novel Labs Inc, Salix Pharms, Meda Pharms, Quantum Pharmics, King Pharms, Aiping Pharm Inc, Chartwell Rx, Clonmel, Halsey, Impax Labs Inc, Interpharm, Ipca Labs Ltd, Mutual Pharm, Northstar Hlthcare, Par Pharm, Sandoz, Schering, Strides Pharma Intl, Sun Pharm Industries, Superpharm, Usl Pharma, and Watson Labs, and is included in sixty-five NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metoclopramide hydrochloride has thirteen patent family members in seven countries.

There are six drug master file entries for metoclopramide hydrochloride. Thirty-four suppliers are listed for this compound.

Summary for METOCLOPRAMIDE HYDROCHLORIDE

International Patents:	13
US Patents:	7
Tradenames:	10
Applicants:	43
NDAs:	65
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	305
Patent Applications:	1,720
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METOCLOPRAMIDE HYDROCHLORIDE
What excipients (inactive ingredients) are in METOCLOPRAMIDE HYDROCHLORIDE?	METOCLOPRAMIDE HYDROCHLORIDE excipients list
DailyMed Link:	METOCLOPRAMIDE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for METOCLOPRAMIDE HYDROCHLORIDE

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

Sponsor	Phase
Montefiore Medical Center	PHASE4
Mercy Bon Secours Saint Vincent Medical Center	PHASE3
Umraniye Education and Research Hospital	NA

See all METOCLOPRAMIDE HYDROCHLORIDE clinical trials

Pharmacology for METOCLOPRAMIDE HYDROCHLORIDE

Drug Class	Dopamine-2 Receptor Antagonist
Mechanism of Action	Dopamine D2 Antagonists

Medical Subject Heading (MeSH) Categories for METOCLOPRAMIDE HYDROCHLORIDE

Antiemetics

Dopamine D2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for METOCLOPRAMIDE HYDROCHLORIDE

A03FA	Propulsives
A03F	PROPULSIVES
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for METOCLOPRAMIDE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GIMOTI	Metered Nasal Spray	metoclopramide hydrochloride	15 mg/spray	209388	1	2021-12-30
METOZOLV ODT	Orally Disintegrating Tablets	metoclopramide hydrochloride	5 mg and 10 mg	022246	1	2010-08-24

US Patents and Regulatory Information for METOCLOPRAMIDE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aiping Pharm Inc	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	072215-001	Jan 30, 1990	AB	RX	No	No
Teva	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	SOLUTION;ORAL	071315-001	Jun 30, 1993		DISCN	No	No
Ani Pharms	REGLAN	metoclopramide hydrochloride	TABLET;ORAL	017854-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Hospira	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	070505-001	Jun 23, 1989		DISCN	No	No
Mutual Pharm	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	070660-001	Feb 10, 1987		DISCN	No	No
Clonmel	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	072639-001	May 9, 1991		DISCN	No	No

Expired US Patents for METOCLOPRAMIDE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005
Hikma	REGLAN	metoclopramide hydrochloride	INJECTABLE;INJECTION	017862-001	Approved Prior to Jan 1, 1982
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-001	Sep 4, 2009
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-002	Sep 4, 2009
Hikma	REGLAN	metoclopramide hydrochloride	INJECTABLE;INJECTION	017862-004	May 28, 1987

International Patents for METOCLOPRAMIDE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Canada	3224872	FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE)
Poland	2376075
Canada	2780485	FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE)
World Intellectual Property Organization (WIPO)	2018112061
Canada	3155873	FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE)
European Patent Office	3554489

Market Dynamics and Financial Trajectory for Metoclopramide Hydrochloride

Last updated: January 25, 2026

Summary

Metoclopramide Hydrochloride (hereafter, metoclopramide) is a dopamine antagonist primarily used for gastroesophageal reflux disease (GERD), diabetic gastroparesis, and nausea/vomiting. The growing prevalence of gastrointestinal disorders, coupled with expanding indications and generic availability, influences its global market trajectory. Despite regulatory concerns over adverse effects such as tardive dyskinesia, the drug's cost-effectiveness sustains steady demand, particularly in markets with limited access to newer therapies. This report synthesizes current market dynamics, financial forecasts, regulatory environments, competition, and key factors influencing its evolution from 2023 onwards.

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Global Market Overview

Parameter	Details
Estimated Market Size (2023)	USD 225 million (approximate)
CAGR (2023-2028)	4.2% (compound annual growth rate)
Major Regions	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Key Drivers	Rising gastrointestinal disorders, generic drug penetration, healthcare infrastructure expansion in emerging markets

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Current Market Contributors and Players

Company	Product/Formulation	Market Share (Estimate)	Notable Attributes
Teva Pharmaceuticals	Metoclopramide Injection & Tablets	35%	Widely generic, accessible pricing
Mylan (now part of Viatris)	Oral & injectable forms	25%	Low-cost alternatives
Pfizer	Brand: Reglan (discontinued in some regions)	15%	Traditional innovator, phased out in some markets due to safety concerns
Others	Various generics	25%	Fragmented competition

Note: Market share data estimated based on industry reports (IQVIA, 2022).

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Market Dynamics

1. Demand Drivers

• Prevalence of Gastrointestinal Disorders: GERD affects an estimated 20-30% of the Western population (source: American Gastroenterological Association). Diabetic gastroparesis affects approximately 5% of diabetics globally.
• Emerging Markets Expansion: Increasing awareness and healthcare access in Asia-Pacific and Latin America expand demand.
• Cost-Effective Therapy: Generic availability underpins sustained use where newer agents are unaffordable or contraindicated.
• Regulatory Restraints & Reassessment: While safety concerns impact prescribing patterns, off-label and complementary use sustains demand.

2. Supply Chain & Manufacturing Trends

• Generic Dominance: Dominated by off-patent formulations, maintaining low manufacturing costs.
• Quality & Safety Regulations: Stricter pharmacovigilance in Europe and North America influences manufacturing standards.

3. Regulatory Environment

• FDA & EMA: Restrictions on high-dose regimens due to neurotoxicity risks; monitors cumulative exposure.
• Regional Variations: Some countries restrict usage or require special labeling.
• Off-label Use & Approved Indications: Expanding in some jurisdictions for antiemetic use in chemotherapy patients.

4. Competitive Landscape

• Benchmarking against newer antiemetics and prokinetics (e.g., 5-HT3 antagonists, motilin receptor agonists).
• Drug shortages and supply issues occasionally disrupt availability.
• Emerging alternatives: E.g., dopamine antagonists with better safety profiles, impacting demand.

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Financial Trajectory and Forecasts

Year	Estimated Market Size (USD million)	Key Factors Influencing Growth
2023	225	Established generic use, safety regulations tightening
2024	235	Stable demand, emerging markets’ growth
2025	245	Increased awareness, expanded indications
2026	255	Continued generic penetration, healthcare access improvements
2027	266	Regulatory adjustments, potential production disruptions
2028	278	Slight acceleration in demand driven by aging populations

CAGR (2023-2028): 4.2%

Revenue Breakdown by Region (2023)

Region	Market Share	USD (million)	Growth Drivers
North America	40%	90	High prevalence, regulatory restrictions
Europe	25%	56	Established usage, safety monitoring
Asia-Pacific	20%	45	Rapid healthcare expansion, demographic shifts
Latin America & Africa	15%	34	Growing demand, affordability considerations

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Factors Impacting Financial Trajectory

Factor	Impact	Description
Regulatory Restrictions	Negative	Limits high-dose usage, impacting sales volume
Safety Concerns	Negative	Tardive dyskinesia risks reduce off-label prescribing
Patent & Patent Expirations	Neutral	Entire active ingredient is off-patent; high generic competition
Development of Alternatives	Neutral to Positive	Newer agents with better safety profiles may supplant metoclopramide in certain indications
Healthcare Infrastructure Development	Positive	Better diagnosis & medication accessibility expands potential market

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Comparative Analysis: Metoclopramide vs. Alternatives

Parameter	Metoclopramide	5-HT3 Antagonists (e.g., Ondansetron)	Motilin Receptor Agonists (e.g., Erythromycin)
Indications	Nausea, GERD, gastroparesis	Chemotherapy-induced nausea	Gastroparesis, prokinetic
Safety Profile	Neurotoxicity risks	Safer, but limited for gastroparesis	Off-label, antibiotic resistance concerns
Cost	Low (generic)	Higher	Variable
Regulatory Status	Restricted in some regions	Widely approved	Off-label uses growing

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Regulatory and Policy Considerations

• FDA Warnings (2009, 2019): Diminished prescribing for ≥12-week courses due to neurotoxicity risk.
• EMA (2013): Restrictions on chronic use.
• WHO Guidelines: Recommends cautious use balancing benefits and risks.
• Pricing & Reimbursement Policies: Favor affordability; reimbursement schemes often favor generics.

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Key Challenges and Opportunities

Challenges	Opportunities
Safety concerns affecting prescriber confidence	Enhancing safety profiles through formulation improvements
Regulatory restrictions limiting scope	Expanding indications with supportive safety data
Competition from newer therapies	Positioning as cost-effective, established option
Supply chain disruptions	Developing resilient manufacturing capabilities

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Impact of Future Trends

Trend	Potential Impact on Market & Financials
Aging populations	Increased prevalence of gastroparesis & GERD
Digital health initiatives	Better disease management, increased medication adherence
Innovation in prokinetics	Possible displacement or augmentation of metoclopramide use
Policy shifts toward safer drugs	Tightened restrictions could reduce prescribing volumes

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Conclusion

Metoclopramide hydrochloride remains a foundational agent for gastrointestinal indications primarily due to its cost-effectiveness and established efficacy. Market growth is expected to continue modestly, driven by increased prevalence of GI disorders, particularly in emerging regions, alongside expanding healthcare access. However, safety concerns and regulatory restrictions temper growth optimism. Companies and policymakers must balance affordability with safety, fostering innovation—such as safer prokinetic alternatives—to sustain long-term market relevance.

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Key Takeaways

• The global market for metoclopramide is estimated at USD 225 million (2023), with a projected CAGR of 4.2% through 2028.
• Generic competition dominates, ensuring affordability but also heightening sensitivity to regulatory and safety challenges.
• Demand persists due to high prevalence of GI conditions, especially in emerging markets.
• Safety concerns, particularly neurotoxicity, influence prescribing patterns, regulatory policies, and potential market expansion.
• Future growth opportunities include reformulation for improved safety, expanded indications, and integration with digital health solutions.

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FAQs

Q1: How do safety concerns impact the market for metoclopramide?
A1: Safety issues, notably the risk of tardive dyskinesia, have led to regulatory restrictions and cautious prescribing, especially for chronic or high-dose use. This limits market growth but preserves demand for short-term, low-dose indications.

Q2: Which regions are expected to see the fastest growth for metoclopramide?
A2: Asia-Pacific and Latin America are anticipated to experience higher growth rates owing to increasing healthcare infrastructure and GI disorder prevalence.

Q3: What are the primary alternatives to metoclopramide, and how do they compare?
A3: Alternatives include 5-HT3 antagonists like ondansetron and erythromycin (a motilin agonist). They often have better safety profiles but vary in efficacy, cost, and regulatory acceptance.

Q4: How does patent expiration influence the market trajectory?
A4: Complete patent expiry has led to a saturated generic market, maintaining affordability but also intensifying price competition and limiting revenue growth for individual manufacturers.

Q5: What strategic considerations should pharmaceutical companies adopt concerning metoclopramide?
A5: Companies should focus on safety improvements, exploring new formulations, and expanding indications while monitoring regulatory changes and market preferences for cost-effective GI therapies.

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References

1. American Gastroenterological Association. (2020). Gastroesophageal Reflux Disease (GERD).
2. IQVIA. (2022). Global Pharmaceutical Market Analysis.
3. U.S. Food and Drug Administration. (2019). Safety Announcement on Metoclopramide.
4. European Medicines Agency. (2013). Guideline on the use of metoclopramide.
5. World Health Organization. (2021). Essential Medicines List.

[Note: All numerical estimates are based on available industry reports and may vary with future market developments.]