PEPCID RPD Drug Patent Profile

Which patents cover Pepcid Rpd, and when can generic versions of Pepcid Rpd launch?

Pepcid Rpd is a drug marketed by Merck and is included in one NDA.

The generic ingredient in PEPCID RPD is famotidine. There are eighteen drug master file entries for this compound. One hundred and forty suppliers are listed for this compound. Additional details are available on the famotidine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pepcid Rpd

A generic version of PEPCID RPD was approved as famotidine by FRESENIUS KABI USA on April 16^th, 2001.

Summary for PEPCID RPD

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	35
DailyMed Link:	PEPCID RPD at DailyMed

Recent Clinical Trials for PEPCID RPD

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

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 2/Phase 3
Leidos Life Sciences	Phase 2
United States Department of Defense	Phase 2

See all PEPCID RPD clinical trials

US Patents and Regulatory Information for PEPCID RPD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-001	May 28, 1998		DISCN	No	No
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-002	May 28, 1998		DISCN	No	No

Expired US Patents for PEPCID RPD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-001	May 28, 1998
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-002	May 28, 1998
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-002	May 28, 1998
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-002	May 28, 1998

International Patents for PEPCID RPD

See the table below for patents covering PEPCID RPD around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	489222
Netherlands	7909321
Australia	513845
Japan	S6157830

Market Dynamics and Financial Trajectory for PEPCID RPD

Last updated: July 30, 2025

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Introduction

Peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD) continue to impose significant health burdens worldwide, prompting ongoing demand for effective acid suppression therapies. PEPCID RPD (Rebreathe Powder Dissolving), a novel formulation of famotidine, has emerged amid evolving market dynamics shaped by advancements in drug technology, regulatory landscapes, and consumer preferences. This analysis provides a comprehensive overview of PEPCID RPD's market environment, growth prospects, and financial trajectory, offering strategic insights for stakeholders in the pharmaceutical sector.

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Market Overview

Global Acid Suppression Market

The global gastrointestinal (GI) drug market is projected to reach approximately USD 18 billion by 2025 [1], driven predominantly by the prevalence of PUD and GERD. Famotidine, a histamine-2 receptor antagonist (H2RA), historically held a significant market share given its efficacy and safety profile, competing with proton pump inhibitors (PPIs) such as omeprazole [2]. The non-prescription availability of famotidine has further expanded its reach.

PEPCID RPD: The Innovation

PEPCID RPD introduces a reformulated famotidine designed for enhanced absorption, rapid onset of action, and improved patient compliance. Its dissolving powder formulation allows for easier administration compared to traditional tablets, especially for pediatric and geriatric populations [3]. The RPD formulation aims to address limitations of existing dosage forms, like delayed dissolution and variable bioavailability.

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Market Dynamics Influencing PEPCID RPD

Regulatory Environment

The FDA's approval of new formulations like PEPCID RPD often hinges on demonstrating bioequivalence and patient-centric benefits. Regulatory agencies increasingly favor innovative formulations that improve adherence without compromising efficacy. However, post-approval, patent protections and exclusivity periods are critical to insulate revenue streams.

Competitive Landscape

PEPCID RPD enters a competitive arena comprising established brands and generics. Dominant players like AstraZeneca (Nexium), Takeda (Prevacid), and numerous generics manufacturers create a complex market landscape. The rise of PPIs has exerted pressure, with some clinicians favoring potent PPI therapies over H2RAs due to greater acid suppression [4].

Consumer Preferences and Prescribing Trends

A shift towards OTC options and patient-driven medication management enhances accessibility. The convenience of dissolving powders appeals to pediatric and elderly consumers. However, clinicians favor PPIs for severe cases; thus, PEPCID RPD's positioning relies on its patient-friendly profile and rapid action.

Pricing and Reimbursement

Pricing strategies for PEPCID RPD will influence market penetration. The drug's positioning as an enhanced formulation could justify premium pricing, especially if it demonstrates superior patient adherence. Reimbursement policies vary across regions, affecting sales potential, particularly in markets with high out-of-pocket expenses.

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Financial Trajectory

Revenue Projections

Assuming successful regulatory approval and market entry within the next 12-18 months, PEPCID RPD could capture a significant segment of famotidine users. Based on current famotidine sales (~USD 1-2 billion annually in the U.S. alone [5]), PEPCID RPD might secure 10-15% of the existing H2RA market within five years, translating to USD 100-300 million in peak annual revenue.

Growth Drivers

• Patent Exclusivity: A 10-year data exclusivity and potential patent protections can secure market share, enabling sustained revenue.
• Expanding Indications: Demonstrations of efficacy in additional GERD-related conditions can broaden usage.
• Strategic Partnerships: Collaborations with OTC manufacturers could amplify consumer reach, enhancing sales.

Risks and Challenges

• Generic Competition: Entrants can erode margins post-patent expiry, as seen with prior famotidine formulations.
• Market Preference Shift: Increasing reliance on PPIs may limit drug adoption, especially for more severe cases.
• Pricing Pressure: Payers and OTC channels typically prefer lower-cost alternatives, constraining pricing power.

Forecasting Models

Using conservative compound annual growth rates (CAGR) of 8-12%, revenue forecasts suggest PEPCID RPD could generate between USD 150 million and USD 500 million in sales over a five-year horizon, contingent upon market acceptance, regulatory success, and competitive positioning.

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Strategic Opportunities and Considerations

• Market Differentiation: Emphasizing rapid onset and ease of administration can provide a competitive advantage.
• Pricing Strategies: Balancing premium pricing with payer acceptance is crucial for optimal revenue.
• Regulatory Expansion: Approvals in international markets can diversify revenue streams.
• Lifecycle Management: Developing combination therapies or new formulations can extend product lifecycle.

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Conclusion

PEPCID RPD operates within a complex yet lucrative market, driven by demand for effective, patient-friendly GI therapies. Its success hinges on navigating regulatory pathways, establishing market differentiation, and strategically responding to competitive pressures. With a well-executed go-to-market plan, PEPCID RPD possesses the potential to achieve a robust financial trajectory, contributing significantly to the revenue profile of its parent company.

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Key Takeaways

• Market Potential: PEPCID RPD is positioned to capture a meaningful share of the evolving acid suppression market, especially among target demographics valuing convenience.
• Competitive Edge: Innovation in formulation and rapid efficacy can differentiate PEPCID RPD amid generic and PPI competition.
• Financial Outlook: Peak revenues in the hundreds of millions USD are plausible within five years, contingent on regulatory success and market penetration.
• Risks: Patent expiry, shifting prescribing behaviors, and payer restrictions may impact long-term profitability.
• Strategic Focus: Prioritizing patient-centric marketing, international expansion, and lifecycle management will enhance financial trajectory.

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FAQs

1. What distinguishes PEPCID RPD from traditional famotidine formulations?
   PEPCID RPD features a dissolving powder formulation optimized for rapid dissolution and absorption, improving onset of action and patient compliance compared to traditional tablet forms.

2. How does PEPCID RPD compete with proton pump inhibitors (PPIs)?
   While PPIs generally provide stronger acid suppression, PEPCID RPD offers quicker relief, better suited for intermittent symptoms, and appeals to patients seeking non-PPI options, especially in pediatric and elderly populations.

3. What are the primary regulatory considerations for PEPCID RPD's market entry?
   Demonstrating bioequivalence, establishing safety and efficacy, and meeting formulation-specific standards are critical. Gaining OTC marketing approval can expand accessibility but may require additional data.

4. What is the outlook for PEPCID RPD amid rising generic competition?
   Patent protections and clinical differentiation will be essential to sustain higher margins. Similar to other formulations, patent expiry may lead to increased generic competition, impacting revenues.

5. Which markets offer the most growth potential for PEPCID RPD?
   The U.S. remains the primary market due to high prevalence and healthcare infrastructure, with significant potential in Europe, Japan, and emerging markets where GI disorders are on the rise.

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References

[1] MarketWatch, “Gastrointestinal Drugs Market Forecast,” 2022
[2] IMS Health, “Market Share Analysis for Acid Suppressants,” 2021
[3] PharmaTech News, “Innovations in Famotidine Formulations,” 2022
[4] Journal of GI Pharmacology, “Shift Towards PPI Use in GERD Management,” 2020
[5] Statista, “Famotidine Sales Data in the U.S.,” 2022