Metoclopramide hydrochloride - Generic Drug Details

What are the generic drug 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-six 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:	36
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	302
Patent Applications:	1,704
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
Affiliated Hospital of Qinghai University	PHASE3
Texas Scottish Rite Hospital for Children	PHASE2

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
Mutual Pharm	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	070660-001	Feb 10, 1987		DISCN	No	No
Interpharm	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	071213-001	Sep 24, 1986		DISCN	No	No
Hospira	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	073118-001	Jan 17, 1991	AP	RX	No	Yes

Expired US Patents for metoclopramide hydrochloride

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
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

International Patents for metoclopramide hydrochloride

Country	Patent Number	Title	Estimated Expiration
Poland	2376075
World Intellectual Property Organization (WIPO)	2010075444
Denmark	2376075

Market Dynamics and Financial Trajectory for Metoclopramide Hydrochloride

Last updated: July 27, 2025

Introduction

Metoclopramide Hydrochloride, a dopamine antagonist primarily used to treat gastrointestinal disorders such as nausea, vomiting, and gastroparesis, remains a staple in the therapeutic landscape. Its versatility across inpatient and outpatient settings bolsters its demand, yet its market trajectory is heavily influenced by regulatory, safety, and competitive factors. This article delineates the evolving market dynamics and project its financial trajectory, offering insights crucial for stakeholders.

Pharmacological and Therapeutic Background

Metoclopramide Hydrochloride acts by enhancing gastrointestinal motility without stimulating acid secretion, which makes it effective in managing conditions like diabetic gastroparesis, reflux, and preoperative nausea. Its widespread use is facilitated by its oral, injectable, and suppository formulations. However, its safety profile—particularly, risks of tardive dyskinesia and neurological adverse effects—limits long-term use, influencing prescribing patterns and market size.

Market Drivers

Growing Prevalence of Gastrointestinal Disorders

The global increase in gastrointestinal conditions, especially among aging populations and those with diabetes, propels demand for effective prokinetic agents like metoclopramide. According to the International Diabetes Federation, the prevalence of diabetes is projected to rise from 537 million in 2021 to 643 million by 2030, indirectly increasing gastroparesis cases and thereby bolstering metoclopramide demand [1].

Expanding Pharmaceutical Pipeline and Off-Label Usage

Ongoing clinical research exploring new indications and optimized formulations (e.g., sustained-release) could extend its therapeutic horizon. Additionally, off-label uses in antiemetic protocols enhance its market footprint, despite regulatory scrutiny.

Regulatory Frameworks and Safety Protocols

Regulatory agencies like the FDA have implemented strict prescribing guidelines to mitigate risks associated with neurological side effects. This prudent regulatory stance restrains overuse but also influences market growth potential, necessitating clinical vigilance and continuous safety profiling.

Market Challenges

Safety and Regulatory Constraints

The black-box warning issued by the FDA in 2009 for risk of tardive dyskinesia largely curtailed prolonged use, especially exceeding 12 weeks [2]. This safety concern diminishes the drug’s long-term demand and shifts focus toward safer alternatives or newer agents, possibly constraining market expansion.

Emergence of Alternatives

The advent of newer antiemetics, such as serotonin antagonists (ondasetron, granisetron) and neurokinin receptor antagonists, offers comparable efficacy with improved safety profiles. These competitors threaten metoclopramide's market share in various segments.

Patent Landscape and Generic Penetration

With patent expirations, the market is flooded with generic formulations, intensifying price competition and squeezing profit margins. Market players face pressure to innovate or differentiate through improved formulations, delivery mechanisms, or combination therapies.

Market Dynamics

Regional Variations

• North America: Highly regulated with considerable adoption driven by established healthcare infrastructures. However, strict safety warnings restrict long-term use.
• Europe: Similar regulatory constraints, with some markets favoring alternative medications due to safety concerns.
• Asia-Pacific: Growing healthcare infrastructure, rising chronic disease burden, and less stringent regulatory environments position the region as a lucrative growth zone.

Market Segmentation

• By Formulation: Orally administered medications dominate retail markets, while injectable forms are preferred in inpatient settings.
• By End-User: Hospitals account for a significant share due to acute indications, but outpatient clinics contribute increasingly, driven by outpatient management trends.

Pricing and Reimbursement Dynamics

Pricing pressures are intensified by the proliferation of generics. Reimbursement policies vary across regions, impacting the drug’s accessibility, especially in lower-income markets where cost sensitivity prevails.

Financial Trajectory

Historical Performance

Over the past decade, global sales of metoclopramide have fluctuated—initial growth driven by increased gastrointestinal disorder prevalence, followed by stabilization due to safety concerns and regulatory restrictions.

Projected Growth Patterns

Despite challenges, the market is expected to grow modestly at a CAGR of approximately 2-3% from 2023 to 2030, driven by regional expansion in emerging markets and niche therapeutic uses. Innovator companies investing in safer formulations or combination therapies may unlock new revenue streams.

Emerging Opportunities

• Development of new formulations: sustained-release or targeted delivery systems could revive market interest.
• Repurposing for novel indications: ongoing research into gastrointestinal motility disorders or antiemetic applications could expand utilization.
• Partnerships and licensing: collaborations with biotech firms could facilitate formulation advancements and extend patent exclusivity.

Risks and Market Exit Considerations

Regulatory setbacks, safety event liabilities, or uncompetitive pricing might prompt market withdrawal by some players. Continuous pharmacovigilance and adherence to evolving safety standards are critical for sustained market presence.

Conclusion

The market for Metoclopramide Hydrochloride is characterized by a delicate balance. Growing demand driven by gastrointestinal disease prevalence is countered by safety concerns, regulatory restrictions, and emerging competitive therapies. Companies that innovate in formulation safety and explore new therapeutic niches will be positioned to capitalize on regional growth opportunities. Overall, the financial trajectory indicates cautious but steady growth, with potential acceleration through strategic R&D and market expansion.

Key Takeaways

• Demand Focused on Safety: Current usage patterns are increasingly governed by safety profiles; long-term viability depends on formulation improvements.
• Regional Growth Opportunities: Emerging markets in Asia-Pacific present substantial growth potential due to rising gastrointestinal conditions and less restrictive regulations.
• Innovation as a Growth Catalyst: Developing safer, unique formulations or new indications can mitigate competitive pressures and extend product lifecycle.
• Regulatory Environment: Vigilance regarding safety warnings and adherence to guidelines remains paramount for market sustainment.
• Strategic Partnerships: Licensing and collaborations serve as vital avenues for innovation, especially within a constrained patent landscape.

FAQs

1. What is the primary therapeutic use of Metoclopramide Hydrochloride?
   It is mainly used to treat nausea, vomiting, and delayed gastric emptying (gastroparesis), especially in diabetic patients.

2. How do safety concerns impact the market for Metoclopramide?
   Safety risks such as tardive dyskinesia have led regulatory agencies to restrict prolonged use, thereby limiting market share and prompting demand for safer alternatives.

3. Are there regional differences in the prescribing of Metoclopramide?
   Yes. North America and Europe prescribe cautiously due to regulatory warnings, whereas Asia-Pacific markets exhibit higher acceptance owing to less stringent regulations and rising gastrointestinal disorder prevalence.

4. What strategies could companies employ to sustain growth?
   Focusing on developing safer formulations, exploring new therapeutic indications, and forming strategic partnerships can help companies maintain competitiveness and growth.

5. What is the near-term financial outlook for Metoclopramide Hydrochloride?
   The market is expected to experience modest growth at a CAGR of approximately 2-3% until 2030, with growth opportunities primarily in emerging markets and through formulation innovation.

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Sources:

[1] International Diabetes Federation. Diabetes Atlas, 9th Edition. 2021.
[2] U.S. Food & Drug Administration. Safety Label Changes for Metoclopramide. 2009.