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, 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, Sun Pharm Industries, Superpharm, Usl Pharma, and Watson Labs, and is included in sixty-five NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metoclopramide hydrochloride has ten patent family members in seven countries.

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

Summary for METOCLOPRAMIDE HYDROCHLORIDE

International Patents:	10
US Patents:	4
Tradenames:	10
Applicants:	43
NDAs:	65
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	266
Patent Applications:	182
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
Health Sciences North Research Institute	N/A
Wollo University	Phase 4
Adwia Pharma, Egypt	Phase 3

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
Lyphomed	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	070293-001	Jan 24, 1986		DISCN	No	No
Superpharm	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	070926-001	Jun 26, 1987		DISCN	No	No
Schering	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	070598-001	Feb 2, 1987		DISCN	No	No
Sun Pharm Industries	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	TABLET;ORAL	071536-002	Jan 16, 1997		DISCN	No	No
Hospira	METOCLOPRAMIDE HYDROCHLORIDE	metoclopramide hydrochloride	INJECTABLE;INJECTION	074147-001	Aug 2, 1996		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	021793-001	Jun 10, 2005
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	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

International Patents for METOCLOPRAMIDE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010075444
Portugal	2376075
Poland	2376075
Canada	3155873	FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE)
Canada	2780485	FORMULATIONS NASALES DE METOCLOPRAMIDE (NASAL FORMULATIONS OF METOCLOPRAMIDE)

METOCLOPRAMIDE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metoclopramide Hydrochloride

Introduction

Metoclopramide hydrochloride, a versatile antiemetic and gastric motility stimulant, has been a staple in the pharmaceutical market for several decades. This article delves into the market dynamics and financial trajectory of this drug, highlighting its indications, market performance, and future outlook.

Approved Indications and Uses

Metoclopramide hydrochloride is indicated for a variety of clinical uses, including:

• Diabetic Gastroparesis: Relief of symptoms associated with acute and recurrent diabetic gastric stasis[1][2][3].
• Prevention of Nausea and Vomiting: Associated with emetogenic cancer chemotherapy and postoperative nausea and vomiting[1][2][3].
• Small Bowel Intubation: Facilitating intubation in adults and pediatric patients[1][2].
• Radiological Examination: Stimulating gastric emptying and intestinal transit of barium for diagnostic purposes[1][2].

Market Performance

The market for metoclopramide hydrochloride has shown stability and growth, driven by its critical role in managing various gastrointestinal and chemotherapy-related conditions.

Sales and Revenue

As of June 2023, metoclopramide injection had U.S. sales of approximately $12.7 million over the preceding twelve months. This figure indicates a steady demand for the drug, particularly in the injectable form[1].

Competitive Landscape

The market for metoclopramide is competitive, with multiple generic and branded versions available. Companies like Avenacy, which recently launched a generic version of metoclopramide injection, are contributing to the market's dynamics by offering differentiated packaging and labeling to enhance patient safety and care[1].

Financial Trajectory

The financial trajectory of metoclopramide hydrochloride is influenced by several factors, including market demand, competition, and regulatory approvals.

Recent Launches and Expansions

Avenacy's launch of metoclopramide injection in the U.S. market is a significant event, marking the company's thirteenth product launch since its inception. This launch is supported by a recent capital infusion, positioning the company for further growth and expansion in the specialty pharmaceutical sector[1].

Market Size and Growth Projections

The global metoclopramide API market is anticipated to grow substantially over the next few years. While exact figures are not provided, the market is expected to reach a significant value by 2031, driven by increasing demand for antiemetic and gastric motility stimulants[4].

Pharmacological and Pharmacokinetic Profile

Understanding the pharmacological and pharmacokinetic properties of metoclopramide is crucial for its market positioning.

Mechanism of Action

Metoclopramide exerts its effects by inhibiting dopamine D2 and serotonin 5-HT3 receptors, enhancing gastrointestinal motility, and increasing lower esophageal sphincter (LES) and gastric tone[2][3].

Absorption, Distribution, and Elimination

The drug is rapidly absorbed, with a bioavailability of approximately 40.7% for oral preparations and 47% for nasal formulations. It has a high volume of distribution (about 3.5 L/kg) and is metabolized primarily by CYP2D6 and CYP3A4 enzymes. The elimination half-life is around 5 to 6 hours in individuals with normal renal function, but this can be prolonged in patients with renal impairment[2][3].

Adverse Effects and Safety Considerations

Metoclopramide is associated with several adverse effects, including the risk of tardive dyskinesia, a serious and often irreversible movement disorder. This risk increases with the duration and cumulative dose of the treatment. Other extrapyramidal side effects such as parkinsonism, dystonia, and akathisia are also significant concerns[1][2][5].

Regulatory and Compliance Aspects

The FDA approval and compliance with cGMP standards are critical for the market success of metoclopramide. Companies like Avenacy ensure that their manufacturing partners undergo successful FDA inspections, which is essential for maintaining market trust and regulatory compliance[1].

Patient Safety and Care

Enhancing patient safety is a key focus for manufacturers. Avenacy's highly differentiated packaging and labeling are designed to support accurate medication selection, aligning with the company's mission to champion patient safety and streamline patient care[1].

Future Outlook

The future outlook for metoclopramide hydrochloride is positive, driven by ongoing demand for effective antiemetic and gastric motility stimulants.

Market Growth Drivers

• Increasing incidence of diabetes and associated complications like gastroparesis.
• Growing need for effective antiemetic agents in chemotherapy.
• Advancements in formulation and delivery systems, such as nasal sprays and injectables.

Challenges and Opportunities

• Managing the risk of adverse effects, particularly tardive dyskinesia, through careful dosing and monitoring.
• Expanding the product portfolio through innovative formulations and partnerships.
• Capitalizing on the growing demand in emerging markets.

Key Takeaways

• Metoclopramide hydrochloride is a critical drug with multiple indications, including diabetic gastroparesis, prevention of nausea and vomiting, and radiological examinations.
• The market for metoclopramide is stable with growth potential, driven by recent launches and expanding demand.
• The drug's pharmacological profile and safety considerations are crucial for its market positioning.
• Regulatory compliance and patient safety initiatives are essential for maintaining market trust.

FAQs

1. What are the primary indications for metoclopramide hydrochloride? Metoclopramide hydrochloride is indicated for the relief of symptoms associated with diabetic gastroparesis, prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, prevention of postoperative nausea and vomiting, small bowel intubation, and radiological examination[1][2][3].

2. What are the common adverse effects of metoclopramide? Common adverse effects include tardive dyskinesia, dystonia, akathisia, and other extrapyramidal symptoms. The risk of these effects increases with the duration and cumulative dose of the treatment[1][2][5].

3. How is metoclopramide metabolized and eliminated? Metoclopramide is metabolized primarily by CYP2D6 and CYP3A4 enzymes in the liver and eliminated mainly through the kidneys. The elimination half-life is around 5 to 6 hours in individuals with normal renal function but can be prolonged in patients with renal impairment[2][3].

4. What is the current market size and growth projection for metoclopramide? The exact current market size is not specified, but the global metoclopramide API market is anticipated to grow significantly by 2031, driven by increasing demand for antiemetic and gastric motility stimulants[4].

5. What recent developments have impacted the market for metoclopramide? Avenacy's recent launch of metoclopramide injection in the U.S. market, supported by a capital infusion, has contributed to the market's dynamics and growth potential[1].

Cited Sources:

1. Avenacy Announces Launch of Metoclopramide Injection, USP in the U.S. Market - Biospace
2. Metoclopramide: Uses, Interactions, Mechanism of Action - DrugBank
3. Metoclopramide Hydrochloride - DailyMed
4. Global Metoclopramide API Market Size, Scope And Forecast Report - Market Research Intellect
5. Metoclopramide-Induced Parkinsonism in Hemodialysis Patients - JAMA Internal Medicine