PEPCID Drug Patent Profile

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

Pepcid is a drug marketed by Salix Pharms, Merck, Bausch, Kenvue Brands, J And J Consumer Inc, and Merck Sharp Dohme. and is included in nine NDAs.

The generic ingredient in PEPCID is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for PEPCID

US Patents:	0
Applicants:	6
NDAs:	9
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	35
Drug Prices:	Drug price information for PEPCID
What excipients (inactive ingredients) are in PEPCID?	PEPCID excipients list
DailyMed Link:	PEPCID at DailyMed

See drug prices for PEPCID

Recent Clinical Trials for PEPCID

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 clinical trials

US Patents and Regulatory Information for PEPCID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987		DISCN	Yes	No
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999		DISCN	No	No
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986		DISCN	Yes	No

Expired US Patents for PEPCID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-001	Oct 15, 1986

International Patents for PEPCID

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

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

Market Dynamics and Financial Trajectory for PEPCID

Last updated: July 30, 2025

Introduction

PEPCID, known generically as famotidine, is a histamine-2 (H2) receptor antagonist primarily prescribed for managing gastroesophageal reflux disease (GERD), peptic ulcer disease, and Zollinger-Ellison syndrome. Launched by major pharmaceutical companies in the early 1980s, PEPCID has historically been a significant player in the over-the-counter (OTC) and prescription drug markets. Over recent years, the landscape for famotidine and the PEPCID brand has experienced notable shifts owing to evolving market trends, patent considerations, regulatory changes, and competitive pressures. This analysis evaluates the current market dynamics and projects PEPCID’s financial trajectory based on industry patterns and emerging trends.

Market Landscape and Key Drivers

Historical Market Position and Brand Significance

PEPCID established its dominance in the 1980s and 1990s as a leading H2 receptor antagonist, competing mainly against ranitidine and cimetidine. Its favorable safety profile and efficacy bolstered its widespread usage. As a prescription medication, PEPCID generated substantial revenues; later, the transition of famotidine to OTC status broadened its accessibility, significantly impacting market volume.

Impact of Patent Expiry and Generic Competition

Patent expiration for PEPCID's major formulations in the U.S. occurred in the early 2000s. The flood of generic famotidine products commoditized the market, reducing the brand’s market share and profit margins for branded PEPCID. Generic manufacturers captured a large segment due to lower pricing, rendering PEPCID increasingly dependent on brand loyalty and marketing to preserve revenue streams.

Shifts in Regulatory and Public Health Dynamics

A pivotal development was the outbreak of NDMA (N-Nitrosodimethylamine) contamination concerns in ranitidine (Zantac), which collectively elevated famotidine’s prominence as a safer alternative. This temporarily boosted PEPCID’s market share as consumers and providers shifted preferences. Consequently, regulatory scrutiny on H2 antagonists heightened, influencing formulation safety and manufacturing standards.

Emergence of Proton Pump Inhibitors (PPIs)

PPIs, such as omeprazole and esomeprazole, have gained dominance over H2 antagonists owing to superior efficacy in acid suppression. The heightened adoption of PPIs has encroached upon the PEPCID market, especially for chronic conditions requiring potent acid suppression, leading to a gradual decline in PEPCID’s prescription volumes.

COVID-19 Pandemic and Market Disruptions

The pandemic induced significant disruptions in supply chains, elective procedures, and routine prescribing behaviors. However, during COVID-19, famotidine garnered interest due to preliminary hypotheses about possible therapeutic effects against SARS-CoV-2. While subsequent research did not substantiate these claims broadly, initial market speculation temporarily influenced demand dynamics for famotidine-based products.

Current Market Dynamics

Market Share Resilience and Challenges

Despite increased competition, PEPCID sustains a niche in specific segments. Its over-the-counter positioning has facilitated continued consumer access, maintaining steady sales, especially among patient populations seeking low-cost, proven therapies. Nevertheless, the brand faces stiff competition from low-cost generics and PPI alternatives, pressing margins.

Regulatory Environment and Patent Landscape

Legal challenges regarding formulation patents and exclusivity rights present both risks and opportunities. Patent expirations continue to open markets to generics, compressing prices. Conversely, emerging formulations or delivery methods—such as extended-release or combination therapies—could offer patentability advantages.

Emerging Therapeutic Innovations

R&D efforts targeting G-protein-coupled receptor pathways or novel acid-suppressing agents could redefine treatment paradigms, further impacting PEPCID’s long-term viability. The pill's position is also influenced by personalized medicine trends and targeted therapy developments for GERD and related conditions.

Financial Trajectory

Revenue Trends and Forecast

Historical data reveals a peak in PEPCID’s revenues during the late 1990s to early 2000s, with subsequent decline due to generics and increased competition (ref. [1]). Currently, the brand generates modest but stable revenue streams primarily from OTC sales, with estimates placing annual sales in the range of hundreds of millions USD globally.

Forecasts suggest a gradual decline in PEPCID revenues over the next five years if no new formulations or indications are developed. However, strategic repositioning, such as through marketing, new patent filings, or formulations, could mitigate declines.

Profitability and Market Valuation

Profit margins for PEPCID have narrowed, burdened by intense price competition among generics and regulatory costs. Nevertheless, the brand remains a valuable asset within large pharmaceutical portfolios, with valuation heavily influenced by potential pipeline innovations and market share stabilization.

Future Growth Opportunities

Potential avenues include:

• OTC Market Expansion: Capitalizing on consumer interest in affordable, safe acid reducers.
• New Indications: Securing approval for additional gastrointestinal or systemic conditions.
• Formulation Innovation: Developing long-acting or combination products to secure patent protection and differentiate from generic competitors.
• Strategic Alliances: Partnering for global distribution or co-development initiatives.

Strategic Considerations and Risks

• Patent and Exclusivity Risks: Loss of exclusivity accelerates commoditization.
• Competitive Pressure: PPIs continue to erode the market share of H2 antagonists.
• Regulatory Challenges: Safety concerns and label revisions may impact sales.
• Market Access: Shifts towards personalized medicine and alternative therapies could limit PEPCID’s utility.

Conclusion: Future Outlook for PEPCID

The pharmaceutical landscape for PEPCID is characterized by maturation and competitive pressures, with revenues likely to decline modestly unless proactive repositioning occurs. Innovation, strategic formulation development, and expansion into emerging markets could offer resilience. The brand’s value will increasingly depend on its ability to adapt through patent protections, shifts in consumer preferences, and regulatory compliance. For stakeholders and investors, ongoing monitoring of patent statuses, regulatory rulings, and market access initiatives is essential for informed decision-making.

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Key Takeaways

• Market share has declined significantly since patent expirations, with fierce generic competition and the rise of PPIs.
• PEPCID’s OTC sales provide stability, but overall revenues are expected to gradually diminish without innovation.
• Emerging formulations and repositioning strategies are critical for extending the brand’s financial viability.
• Regulatory and patent landscapes remain pivotal; patent expirations could accelerate commoditization.
• Aligning with evolving consumer preferences and exploring new indications will be vital for future growth.

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FAQs

1. What is the primary competition for PEPCID in current markets?
The main competitors are generic famotidine products and proton pump inhibitors such as omeprazole and esomeprazole, which offer more potent acid suppression.

2. How does patent expiration affect PEPCID’s market position?
Patent expiration allows generic manufacturers to produce lower-cost versions, significantly reducing branded PEPCID’s market share and profit margins.

3. Are there new formulations or indications in development for famotidine?
As of now, no major new formulations have been approved. Innovators are exploring extended-release versions and combination therapies, which could provide patent protections and market differentiation.

4. What role did COVID-19 play in PEPCID’s recent market dynamics?
Initial interest in famotidine as a potential COVID-19 treatment temporarily increased demand, but subsequent research did not confirm significant antiviral effects, leading to stabilization or decline in these speculative sales.

5. What strategic moves can preserve PEPCID’s market relevance?
Innovating new formulations, expanding indications, leveraging OTC channels, and securing patent protections are key to maintaining its market presence amid intense competition.

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Sources:

1. IMS Health (now IQVIA). Pharmaceutical Market Data Analysis.
2. U.S. Food and Drug Administration (FDA). ANDA Approvals and Patent Data.
3. Market research reports on gastrointestinal therapeutics.
4. Peer-reviewed studies on famotidine efficacy and safety profiles.