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Last Updated: January 13, 2025

REGLAN Drug Patent Profile


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Summary for REGLAN
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Recent Clinical Trials for REGLAN

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SponsorPhase
Mercy Health SystemPhase 4
Women and Infants Hospital of Rhode IslandPhase 2
Emory UniversityPhase 4

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Pharmacology for REGLAN

US Patents and Regulatory Information for REGLAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Meda Pharms REGLAN ODT metoclopramide hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021793-002 Jun 10, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms REGLAN metoclopramide hydrochloride TABLET;ORAL 017854-002 May 5, 1987 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-004 May 28, 1987 DISCN 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

Expired US Patents for REGLAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hikma REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-001 Approved Prior to Jan 1, 1982 4,536,386 ⤷  Subscribe
Hikma REGLAN metoclopramide hydrochloride INJECTABLE;INJECTION 017862-004 May 28, 1987 4,536,386 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

REGLAN Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Reglan (Metoclopramide)

Overview of Reglan

Reglan, also known as metoclopramide, is a prescription medication used to treat various gastrointestinal problems, including gastroesophageal reflux and diabetic gastroparesis. It is classified as an antiemetic, which means it is used to prevent nausea and vomiting, often associated with conditions like chemotherapy, general anesthetics, and other gastrointestinal disorders[4].

Market Positioning

Reglan is part of the broader antiemetics market, which is experiencing significant growth driven by increasing incidences of cancer, gastroenteritis, and other conditions that require antiemetic treatments.

Antiemetics Market Context

The global antiemetics drugs market was valued at USD 7.49 billion in 2023 and is expected to grow at a CAGR of 5.98% from 2024 to 2030, reaching USD 11.20 billion by 2030. This growth is fueled by rising drug approvals, research activities, and the increasing prevalence of cancer and other gastrointestinal disorders[1].

Segments and Applications

Reglan falls under several segments within the antiemetics market:

Drug Type

Reglan is categorized under dopamine receptor antagonists, one of the key segments in the antiemetics market. While serotonin-receptor antagonists dominate the market with a share of 29.71%, dopamine receptor antagonists also play a significant role[1].

Applications

Reglan is primarily used for:

  • Gastroesophageal Reflux: It is indicated for the treatment of symptomatic gastroesophageal reflux in adults who fail to respond to conventional therapy.
  • Diabetic Gastroparesis: It provides relief for symptoms in adults with acute and recurrent diabetic gastroparesis[3].

End-Use and Distribution

Reglan is distributed through various channels, with retail pharmacies being a dominant segment. Retail pharmacies accounted for 47.91% of the market share in 2023, driven by product availability and convenience[1].

Regional Performance

The antiemetics market, including Reglan, is geographically diverse:

North America

North America dominated the antiemetics market with a share of 36.52% in 2023. This region is expected to continue its strong performance due to the presence of key players and rising approvals for antiemetics drugs[1].

Other Regions

The Asia Pacific region is also expected to grow significantly, driven by rising incidences of cancer and gastroenteritis. For instance, the number of cancer cases in India is projected to increase by 12.8% from 2020 to 2025, which will drive the demand for antiemetics in this region[1].

Financial Trajectory

While specific financial data for Reglan is not provided, its performance can be inferred from the broader antiemetics market trends:

Revenue Growth

The antiemetics market's growth rate of 5.98% CAGR from 2024 to 2030 indicates a positive financial trajectory. Given Reglan's established presence and continued use in treating gastrointestinal issues, it is likely to contribute to this growth.

Market Challenges

Despite the positive outlook, Reglan faces challenges such as the risk of serious side effects, including tardive dyskinesia, which could impact its market share. The FDA has issued a black-box warning for Reglan due to this risk, which may influence prescribing patterns and patient compliance[4].

Competitive Landscape

Reglan competes in a market with several key players:

  • Pfizer Inc.
  • Cipla Inc.
  • Merck & Co., Inc.
  • Johnson & Johnson Services, Inc.
  • GSK plc.
  • Astellas Pharma Inc.
  • GLENMARK PHARMACEUTICALS LTD.
  • Viatris Inc.
  • Baxter

These companies are actively involved in researching, developing, and receiving approvals for new antiemetic drugs, which can impact Reglan's market share[1].

Regulatory and Safety Considerations

Reglan's use is subject to several regulatory and safety considerations:

  • Dosage and Administration: The drug should not be used for longer than 12 weeks due to the risk of developing tardive dyskinesia[3].
  • Contraindications: Reglan is contraindicated in patients with a history of tardive dyskinesia or dystonic reactions to metoclopramide[3].

Key Takeaways

  • Reglan is part of the growing antiemetics market, driven by increasing incidences of cancer and gastrointestinal disorders.
  • The drug is primarily used for gastroesophageal reflux and diabetic gastroparesis.
  • Retail pharmacies dominate the distribution channel for antiemetics.
  • North America is a key region for the antiemetics market, including Reglan.
  • Despite growth potential, Reglan faces challenges related to serious side effects and regulatory warnings.

FAQs

What is Reglan used for?

Reglan (metoclopramide) is used to treat symptomatic gastroesophageal reflux in adults who fail to respond to conventional therapy and to provide relief for symptoms in adults with acute and recurrent diabetic gastroparesis[3].

What are the potential side effects of Reglan?

Reglan can cause serious side effects, including tardive dyskinesia, a condition involving involuntary facial and body movements. Other risks include hyperprolactinemia, galactorrhea, amenorrhea, gynecomastia, and impotence[3][4].

How does Reglan fit into the broader antiemetics market?

Reglan is part of the dopamine receptor antagonists segment within the antiemetics market, which is expected to grow at a CAGR of 5.98% from 2024 to 2030[1].

What are the distribution channels for Reglan?

Reglan is primarily distributed through retail pharmacies, which accounted for 47.91% of the antiemetics market share in 2023[1].

Are there any regulatory warnings associated with Reglan?

Yes, Reglan has an FDA black-box warning due to the risk of tardive dyskinesia, and it is contraindicated in patients with a history of this condition or dystonic reactions to metoclopramide[3][4].

Sources

  1. Grand View Research: Antiemetics Drugs Market Size & Share Analysis Report 2030
  2. Bristol Myers Squibb: 2012 Annual Report
  3. FDA: REGLAN (metoclopramide) tablets
  4. DrugWatch: Reglan - FDA Black-Box Warning, Tardive Dyskinesia Risk

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