REGLAN ODT Drug Patent Profile

When do Reglan Odt patents expire, and what generic alternatives are available?

Reglan Odt is a drug marketed by Meda Pharms and is included in one NDA.

The generic ingredient in REGLAN ODT 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Reglan Odt

A generic version of REGLAN ODT was approved as metoclopramide hydrochloride by TEVA on July 29^th, 1985.

Summary for REGLAN ODT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	34
Patent Applications:	110
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for REGLAN ODT
DailyMed Link:	REGLAN ODT at DailyMed

Recent Clinical Trials for REGLAN ODT

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

Sponsor	Phase
Mercy Health System	Phase 4
Women and Infants Hospital of Rhode Island	Phase 2
Emory University	Phase 4

See all REGLAN ODT clinical trials

US Patents and Regulatory Information for REGLAN ODT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	Jun 10, 2005		DISCN	No	No
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005		DISCN	No	No

Expired US Patents for REGLAN ODT

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	6,024,981
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005	6,221,392
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-001	Jun 10, 2005	6,221,392
Meda Pharms	REGLAN ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021793-002	Jun 10, 2005	6,024,981

International Patents for REGLAN ODT

See the table below for patents covering REGLAN ODT around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	2147669
Japan	5072513
Canada	2284663	DISSOLUTION RAPIDE DE FORME POSOLOGIQUE DE BONNE TENUE (RAPIDLY DISSOLVING ROBUST DOSAGE FORM)
European Patent Office	2266538	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)

REGLAN ODT Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Reglan ODT

Introduction to Reglan ODT

Reglan ODT (metoclopramide orally disintegrating tablets) is a prokinetic drug used to treat various gastrointestinal conditions, including gastroesophageal reflux disease (GERD) and diabetic gastroparesis. Here, we will delve into the market dynamics and financial trajectory of Reglan ODT.

Market Overview

The global market for orally disintegrating tablets (ODTs), which includes Reglan ODT, is experiencing significant growth. The ODT market is projected to expand from USD 13.2 billion in 2023 to USD 29.0 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 8.2% during the forecast period[3].

Segment Analysis

• Drug Class: While Reglan ODT falls under the category of prokinetic agents, the broader ODT market is dominated by anti-psychotics, which hold a substantial 42% market share. However, the segment for gastrointestinal (GI) diseases, where Reglan ODT is positioned, also shows considerable growth[3].

• Disease Indication: Central Nervous System (CNS) diseases lead the market, but GI diseases, including GERD and diabetic gastroparesis, are significant indicators driving the demand for Reglan ODT[3].

• Distribution Channel: Hospital pharmacies currently hold a substantial 33% market share, which is relevant for Reglan ODT as it is often prescribed in clinical settings[3].

Regional Analysis

• North America: This region dominates the ODT market, accounting for 36% of the market share and generating USD 8.1 billion in revenue in 2023. The acceptance of advanced pharmaceutical products and the prevalence of CNS and GI diseases in North America contribute to this leadership[3].

• Other Regions: The Asia Pacific and Middle East & Africa regions are expected to witness significant growth due to the affordability and increasing awareness of ODTs, including Reglan ODT[3].

Competitive Landscape

The ODT market is highly fragmented, with numerous established and emerging players. Key players include AstraZeneca, Mylan, Pfizer, and Johnson & Johnson, among others. Reglan ODT, marketed by various companies including Evoke Pharma (under the brand name Gimoti), competes within this diverse market[3].

Financial Performance

• Sales Data: The injectable form of metoclopramide, which is closely related to Reglan ODT, had U.S. sales of approximately $12.7 million for the twelve months ending in June 2023. This indicates a stable market presence for metoclopramide-based products[4].

• Revenue Growth: Evoke Pharma, which markets Gimoti (a nasal spray formulation of metoclopramide), reported a 70% increase in quarterly revenue to $2.7 million, highlighting the growing demand for metoclopramide-based treatments[5].

Approved Indications and Usage

Reglan ODT is indicated for the treatment of symptomatic GERD in adults who have failed conventional therapy and for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The drug is administered orally, typically 10 to 15 mg four times daily for 4 to 12 weeks, with a maximum daily dosage of 60 mg[1].

Dosage and Administration

The dosage of Reglan ODT is critical for its effectiveness and safety. The recommended adult dosage is 10 to 15 mg four times daily, administered thirty minutes before each meal and at bedtime. The treatment duration is limited to 12 weeks due to the risk of developing tardive dyskinesia (TD) with longer-term use[1].

Side Effects and Safety Concerns

Reglan ODT is associated with several side effects, including TD, other extrapyramidal effects, neuroleptic malignant syndrome, depression, hypertension, fluid retention, and hyperprolactinemia. These risks necessitate careful patient monitoring and adherence to the recommended treatment duration[1].

Market Trends and Future Outlook

• Innovation: The ODT market is driven by innovation, with companies focusing on new chemical entities and excipients tailored for rare diseases. This trend is expected to continue, potentially expanding the market for Reglan ODT and similar products[3].

• Regional Expansion: The growing acceptance of ODTs in regions like the Asia Pacific and Middle East & Africa is expected to drive market growth. The affordability and convenience of ODTs are key factors in this expansion[3].

• Competitive Dynamics: The entry of new players and the launch of generic equivalents, such as Avenacy's Metoclopramide Injection, USP, will continue to shape the competitive landscape for Reglan ODT[4].

Key Takeaways

• Market Growth: The ODT market, including Reglan ODT, is expected to grow significantly, driven by technological advancements and increasing demand.
• Regional Dominance: North America leads the market, but other regions are expected to show notable growth.
• Competitive Landscape: The market is highly fragmented with both established and emerging players.
• Financial Performance: Stable sales and revenue growth indicate a strong market presence for metoclopramide-based products.
• Safety and Efficacy: Careful administration and monitoring are crucial due to the potential side effects associated with Reglan ODT.

Frequently Asked Questions (FAQs)

1. What are the approved indications for Reglan ODT?

Reglan ODT is approved for the treatment of symptomatic gastroesophageal reflux in adults who have failed conventional therapy and for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis[1].

2. What is the recommended dosage for Reglan ODT?

The recommended adult dosage is 10 to 15 mg four times daily for 4 to 12 weeks, administered thirty minutes before each meal and at bedtime, with a maximum daily dosage of 60 mg[1].

3. What are the potential side effects of Reglan ODT?

Potential side effects include tardive dyskinesia, other extrapyramidal effects, neuroleptic malignant syndrome, depression, hypertension, fluid retention, and hyperprolactinemia[1].

4. How does the market for Reglan ODT compare to the broader ODT market?

The ODT market is growing at a CAGR of 8.2%, with Reglan ODT being part of the GI disease segment, which is a significant but not the dominant segment within the broader market[3].

5. What are the key drivers for the growth of the ODT market?

Key drivers include technological advancements, increasing demand for convenient drug delivery systems, and growing awareness among healthcare professionals and patients about the benefits of ODTs[3].

Cited Sources:

1. RxList: Reglan ODT (Metoclopramide Orally Disintegrating Tablets) - RxList.
2. Evoke Pharma: Real-World Data Analysis Reveals a Lower Risk of Tardive Dyskinesia (TD) with Metoclopramide than Previously Reported.
3. Market.us: Orally Disintegrating Tablet Market Outlook | CAGR of 8.2%.
4. BusinessWire: Avenacy Announces Launch of Metoclopramide Injection, USP in the U.S. Market.
5. Synapse: Metoclopramide Hydrochloride - Drug Targets, Indications, Patents.