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Last Updated: December 22, 2024

METOCLOPRAMIDE Drug Patent Profile


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When do Metoclopramide patents expire, and when can generic versions of Metoclopramide launch?

Metoclopramide is a drug marketed by Avet Lifesciences, Bedford, Fresenius Kabi Usa, Hospira, Lyphomed, Norbrook, Smith And Nephew, Teva Pharms Usa, Actavis Mid Atlantic, Ani Pharms, Chartwell Molecular, Genus, Morton Grove, Paco, Pharmobedient Cnsltg, Roxane, Teva, Vistapharm, Novel Labs Inc, 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 fifty-five NDAs.

The generic ingredient in METOCLOPRAMIDE is metoclopramide hydrochloride. There are fourteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the metoclopramide hydrochloride profile page.

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Drug patent expirations by year for METOCLOPRAMIDE
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Recent Clinical Trials for METOCLOPRAMIDE

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SponsorPhase
Health Sciences North Research InstituteN/A
Wollo UniversityPhase 4
Adwia Pharma, EgyptPhase 3

See all METOCLOPRAMIDE clinical trials

Pharmacology for METOCLOPRAMIDE

US Patents and Regulatory Information for METOCLOPRAMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ipca Labs Ltd METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 078807-001 Jun 12, 2008 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aiping Pharm Inc METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 072215-002 Nov 5, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Schering METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070598-001 Feb 2, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 070453-001 Jun 6, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Northstar Hlthcare METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 078374-002 Nov 30, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma METOCLOPRAMIDE HYDROCHLORIDE metoclopramide hydrochloride TABLET;ORAL 077878-001 Aug 28, 2006 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

METOCLOPRAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Metoclopramide

Introduction

Metoclopramide, a medication used to treat various gastrointestinal disorders, has been a significant player in the pharmaceutical market. This article delves into the market dynamics and financial trajectory of metoclopramide, highlighting its current status, growth prospects, and key players involved.

Market Size and Growth Prospects

The global metoclopramide API market has experienced rapid and substantial growth in recent years. According to market research, the metoclopramide API market is expected to continue its significant expansion from 2023 to 2031. This upward trend is driven by increasing demand for treatments of gastrointestinal disorders such as diabetic gastroparesis, gastroesophageal reflux disease (GERD), and other conditions[1].

Market Segmentation

The metoclopramide API market is segmented based on type (0.98, 0.99, and others) and application (tablets, injections, and others). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This segmentation helps in understanding the diverse market dynamics and identifying opportunities and challenges in different regions[1].

Key Players

Several companies are prominent in the metoclopramide API market. Key players include CR Double-Crane Pharmaceuticals, Hunan Huateng Pharmaceutical, Amsa Spa, Boehringer Ingelheim GmbH, Ipca Laboratories, and others. These companies are involved in the production, distribution, and marketing of metoclopramide API, contributing to the market's growth[1][4].

Financial Performance of Evoke Pharma

Evoke Pharma, a specialty pharmaceutical company, has seen significant financial growth with its nasal spray formulation of metoclopramide, GIMOTI. In Q2 2024, Evoke Pharma reported a 47% quarter-over-quarter and 126% year-over-year increase in net product sales, reaching an annual run-rate exceeding $10 million. The company achieved record-high prescription fills with a 75% year-over-year increase and a 32% growth compared to Q1 2024. Despite a net loss, it narrowed to $1.3 million from $1.9 million in Q2 2023, indicating improved financial health[2].

Market Drivers and Restraints

The growth of the metoclopramide API market is driven by several factors, including the increasing prevalence of gastrointestinal disorders, advancements in drug formulations, and growing demand for effective treatments. However, the market also faces restraints such as regulatory challenges, side effects associated with metoclopramide, and competition from other treatments[1].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics of metoclopramide is crucial for its effective use. Studies have shown that metoclopramide pharmacokinetics are best characterized by a one-compartment open model. In infants with gastroesophageal reflux, metoclopramide has been shown to significantly reduce reflux episodes and improve clinical symptoms[3].

Competitive Scenario

The competitive landscape of the metoclopramide API market is dynamic, with several established and emerging players. Companies like Evoke Pharma are focusing on innovative formulations, such as nasal sprays, to enhance patient compliance and treatment efficacy. The market also sees competition from generic versions of metoclopramide, which can impact pricing and market share[1][2].

Regional Market Analysis

The metoclopramide API market varies significantly across different regions. Asia-Pacific is expected to be a key growth area due to the large patient population and increasing healthcare expenditure. North America and Europe also represent significant markets, driven by advanced healthcare systems and high demand for gastrointestinal treatments[1].

Future Outlook

The future outlook for the metoclopramide API market is promising, with projected robust growth rates from 2023 to 2031. The market is expected to benefit from ongoing research and development in drug formulations, increasing awareness of gastrointestinal disorders, and expanding healthcare infrastructure in emerging markets[1].

Financial Guidance and Cash Position

Evoke Pharma, for instance, has revised its 2024 guidance to $11-12 million, reflecting over 100% growth from the previous year. The company's cash position and future sales of GIMOTI are expected to fund operations into Q2 2025, indicating a stable financial trajectory[2].

Challenges and Opportunities

Despite the positive outlook, the metoclopramide API market faces challenges such as regulatory hurdles, potential side effects, and competition from new treatments. However, these challenges also present opportunities for innovation and market differentiation. Companies that can address these challenges effectively are likely to gain a competitive edge[1].

Key Takeaways

  • The metoclopramide API market is expected to experience significant growth from 2023 to 2031.
  • Key players like Evoke Pharma, Hunan Huateng Pharmaceutical, and Amsa Spa are driving the market.
  • Innovative formulations such as nasal sprays are enhancing patient compliance and treatment efficacy.
  • The market is segmented by type, application, and geography, with Asia-Pacific being a key growth area.
  • Financial performance of companies like Evoke Pharma indicates strong growth and improved financial health.

FAQs

What are the primary applications of metoclopramide?

Metoclopramide is primarily used to treat gastrointestinal disorders such as diabetic gastroparesis, gastroesophageal reflux disease (GERD), and other conditions.

Which companies are key players in the metoclopramide API market?

Key players include CR Double-Crane Pharmaceuticals, Hunan Huateng Pharmaceutical, Amsa Spa, Boehringer Ingelheim GmbH, Ipca Laboratories, and Evoke Pharma.

What is the expected growth rate of the metoclopramide API market?

The market is expected to experience robust growth rates from 2023 to 2031, driven by increasing demand for gastrointestinal treatments.

How has Evoke Pharma's financial performance been with its metoclopramide product, GIMOTI?

Evoke Pharma reported a 47% quarter-over-quarter and 126% year-over-year increase in net product sales for GIMOTI, with record-high prescription fills and a narrowed net loss.

What are the main drivers of the metoclopramide API market?

The main drivers include the increasing prevalence of gastrointestinal disorders, advancements in drug formulations, and growing demand for effective treatments.

Sources

  1. Market Research Intellect, "Global Metoclopramide API Market Size, Scope And Forecast Report".
  2. Stock Titan, "Evoke Pharma, Inc. Reports Second Quarter 2024 Financial Results".
  3. PubMed, "Metoclopramide pharmacokinetics and pharmacodynamics in infants with gastroesophageal reflux".
  4. Valuates Reports, "Metoclopramide Hydrochloride API Market Size".

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