PEPCID Drug Patent Profile

Which patents cover Pepcid, 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-six 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

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
Merck Sharp Dohme	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	020249-001	Feb 18, 1994		DISCN	Yes	No

International Patents for PEPCID

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

Country	Patent Number	Title	Estimated Expiration
Denmark	93580
Netherlands	8001361
Finland	70890
Germany	2951675

PEPCID (Famotidine): Investment Scenario and Fundamentals Analysis

Last updated: February 3, 2026

Executive Summary

Famotidine, marketed as PEPCID, is a histamine-2 (H2) receptor antagonist used in the treatment of gastric ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. The drug's global market faces declining sales due to generic erosion and evolving treatment standards, but the potential for niche resurgence and pipeline developments sustains investor interest.

Market Overview and Revenue Trends

PEPCID's peak revenues occurred in the mid-2000s, with annual sales exceeding $1.2 billion worldwide. Recent years have seen a contraction to approximately $200 million globally, primarily due to patent expiration, generic competition, and regulatory challenges. The product remains a staple in specific markets like the US, where generic famotidine dominates.

Key Market Dynamics

• Patent Expiry and Generic Competition: The original patent expired in 2009. Multiple generics now hold market share, reducing branded PEPCID revenues.

• Pricing Pressure: Increased commoditization impacts margins. US prices for PEPCID generics have declined approximately 85% since 2010.

• Regulatory Environment: FDA approvals for alternative formulations and indications are limited. PEPCID's label has not expanded substantially since its initial approval.

• Therapeutic Shift: PPIs (proton pump inhibitors) like omeprazole have replaced H2 blockers in many indications, halting growth of PEPCID's main markets.

Pipeline and Developmental Potential

• New Formulations: Some companies explore sustained-release or combination products, but none have achieved major market penetration.

• Novel Indications: Research into famotidine’s antiviral properties (notably in COVID-19) has garnered attention but lacks definitive clinical validation and regulatory approval.

• Market Resuscitation Strategies: Limited potential exists for PEPCID to regain significant market share unless repositioned or combined with innovative delivery systems.

Financial Fundamentals

• Revenue: Estimated global revenues of PEPCID declined from a high of over $1.2 billion (2005-2007) to roughly $200 million in recent reported periods.

• Profitability: Contraction in sales has led to decreased gross margins and limited profitability for branded formulations; margins for generics are highly competitive.

• Research & Development (R&D): Minimal current R&D investment is reported for PEPCID; focus shifts toward pipeline and alternative drugs.

• Regulatory Costs: Limited, due to widespread generic approval and low regulatory overhead.

Competitive Landscape

Company	Market Position	Key Assets	Focus & Strategies
Johnson & Johnson	Original patent holder	PEPCID, other H2 antagonists	Patents expired, market decline
Pfizer	Generic manufacturer	Famotidine brands	Price competition, generic dominance
Mylan, Teva	Leading generics providers	Famotidine formulations	Market share in generics

Investment Considerations

• Downside Risks: Market decline, regulatory hurdles, diminished therapeutic relevance, and patent expirations reduce long-term growth prospects.

• Upside Cases: Potential niche resurgence via reformulation, new indications, or synergy with other therapies.

• Volatility: PEPCID's valuation remains sensitive to regulatory decisions, pricing trends in generics, and shifting clinical guidelines.

Regulatory and Patent Status

• Patent Status: Patents protecting PEPCID's formulations expired in the US (2009) and Europe (2010). No new patents are pending that significantly extend exclusivity.

• Regulatory Approvals: US FDA approvals support generic markets. No recent approvals for new indications or formulations.

Conclusion

PEPCID remains a mature product with declining revenues and limited growth prospects. Investment interest hinges on therapeutic repositioning potential, pipeline activity (which is presently negligible), and the ability of competitors and generic manufacturers to erode margins further. The drug’s fundamental decline suggests decreasing valuation unless new opportunities emerge.

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Key Takeaways

• Peak revenues exceeded $1.2 billion; current revenues hover around $200 million.
• Patent expiries and generic competition dominate revenue erosion.
• No substantial pipeline or new indications support future growth.
• Market share is primarily among generic manufacturers, with minimal branded activity.
• Investment risk remains high due to declining relevance and competitive pressure.

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FAQs

1. What is the primary driver of PEPCID's revenue decline?
   Loss of patent protection has led to increased generic competition, significantly reducing the drug's profitability and market share.

2. Are there any current efforts to reformulate PEPCID or develop new indications?
   No significant ongoing R&D efforts target PEPCID specifically. Some research investigates potential antiviral effects, but these are not near commercialization.

3. Can PEPCID regain market share in the future?
   Unlikely without substantial repositioning, new formulations, or indications that differentiate it from cheaper generics or alternative therapies.

4. What is the risk profile for investing in PEPCID?
   High risk due to market contraction, limited growth potential, and the absence of active development pipelines.

5. How does PEPCID compare to other H2 antagonists?
   It is comparable in mechanism and efficacy with other drugs like ranitidine (now withdrawn in some markets) but has seen the largest market erosion among H2 blockers.

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Sources

1. [1] EvaluatePharma, "Famotidine Market Trends," 2022.
2. [2] USFDA, "Drug Approvals and Label Updates," 2022.
3. [3] IMS Health, "Generic Market Share Data," 2021.
4. [4] Company Financial Reports, Johnson & Johnson, Pfizer, Mylan, 2010–2022.
5. [5] MarketWatch, "Pharmaceutical Industry Outlook," 2022.