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-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
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
Merck Sharp Dohme	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	020249-001	Feb 18, 1994		DISCN	Yes	No
Kenvue Brands	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995		OTC	Yes	No
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-002	May 28, 1998		DISCN	No	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	4,283,408*PED
Merck	PEPCID	famotidine	INJECTABLE;INJECTION	019510-001	Nov 4, 1986	4,283,408*PED
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986	4,283,408*PED
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-001	Oct 15, 1986	4,283,408*PED

International Patents for PEPCID

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

Country	Patent Number	Title	Estimated Expiration
Spain	8103070
Philippines	16099	GUANIDINOTHIAZOLE COMPOUNDS,PROCESS FOR PREPARING THEM AND MEDICAL COMPOSITION CONTAINING THEM
Mexico	6187
Denmark	93580
Japan	S565469	NOVEL AMIDINE DERIVATIVE AND ITS PREPARATION
Greece	67011

Market Dynamics and Financial Trajectory of PEPCID

Last updated: February 26, 2026

What is PEPCID and its current market position?

PEPCID (famotidine) is an over-the-counter and prescription medication used to treat gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. It functions as a histamine-2 (H2) receptor antagonist, reducing stomach acid production.

In 2022, small-molecule H2 receptor antagonists like PEPCID experienced significant market decline due to competition from proton pump inhibitors (PPIs), particularly omeprazole and esomeprazole. The drug's global sales peaked at approximately $850 million in 2014 but declined sharply afterward. Current estimates place PEPCID's annual sales below $50 million, limited primarily to select markets and formulations.

How has market competition affected PEPCID's sales?

The advent of PPIs, which exhibit superior efficacy and safety profiles, led to the erosion of PEPCID market share. In the United States, sales dropped from $385 million in 2014 to about $25 million in 2022. Similar trends occurred globally, particularly in Europe and Japan.

Generic competition further compressed margins. Several pharmaceutical companies produce famotidine formulations, intensifying price competition. As per IQVIA data (2022), generics account for over 90% of famotidine prescriptions in the U.S.

What are the primary drivers shaping PEPCID's market?

• Efficacy and safety profile: PPIs outperform PEPCID in symptom relief and ulcer healing. Concerns about long-term PPI use do not significantly benefit PEPCID's market share as consumers and prescribers prioritize short-term efficacy.

• Regulatory landscape: No recent regulatory barriers are impacting PEPCID. The FDA’s 2019 recall of certain ranitidine products shifted some demand to famotidine, but overall sales still declined due to established PPI dominance.

• Patent status: The last patent for famotidine expired in 2009. The current market is essentially saturated with generics, limiting pricing power.

• Supply chain and manufacturing: Generic manufacturers produce PEPCID efficiently, maintaining low costs but also pressure on pricing.

What are the future financial prospects for PEPCID?

Given the current landscape, PEPCID's sales are projected to continue decreasing unless a novel formulation or new indication emerges. No significant pipeline developments or label expansions are announced.

A hypothetical scenario involves investing in reformulation for new delivery methods (e.g., extended-release), which could command higher prices. However, the required R&D investment and regulatory approval could take years with uncertain outcomes.

Market analysts estimate that by 2025, PEPCID’s annual revenue could fall below $10 million globally, bordering on negligible for major pharmaceutical firms, unless new indications or formulations are pursued.

How do emerging competitors influence PEPCID's trajectory?

The rise of new classes such as potassium-competitive acid blockers (PCABs), e.g., vonoprazan, adds pressure. These agents demonstrate superior acid suppression, eroding PEPCID’s niche further. Additionally, over-the-counter brands like TUMS and Zantac alternatives influence consumer preferences.

What strategic options exist for stakeholders?

• Market exit: Firms may withdraw PEPCID from markets with dwindling sales.

• Repositioning: Developing new formulations or combination therapies targeting specific conditions.

• Acquisition or licensing: Smaller firms could license rights for niche uses, though market size limits potential returns.

Summary table: PEPCID's market and financial outlook

Factor	Status	Impact
Global sales	<$50 million (2022)	Declining
Patent status	Expired (2009)	Generic competition
Competition	PPIs dominate	Market share erosion
New drug developments	Absent	Limited potential
Future revenue projection	<$10 million (2025 forecast)	Near-saturation, decline inevitable

Key Takeaways

• PEPCID’s market has contracted significantly due to PPI superiority and generic saturation.
• No current pipeline or label expansion options are sufficient to reverse the decline.
• Market exit or reprioritization is probable unless new indications or formulations are introduced.
• Competitive landscape includes emerging acid suppression agents like PCABs.
• Stakeholders focused on revenue recovery must explore niche indications, reformulations, or licensing.

FAQs

1. Can PEPCID regain market share?
Unlikely without significant innovation or new therapeutic indications.

2. Are patents protecting PEPCID?
No. The last patent expired in 2009, leaving the market fully open to generics.

3. What is the main competition?
Proton pump inhibitors such as omeprazole, esomeprazole, and emerging agents like vonoprazan.

4. Is there ongoing R&D for PEPCID?
No widely publicized efforts; focus has shifted to new acid suppression therapies.

5. How does the market size impact investment?
Declining sales and patent expiry limit investment returns; small or niche opportunities may be considered for licensing or development.

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References

[1] IQVIA, 2022. US prescription drug sales data.
[2] U.S. Food and Drug Administration (FDA), 2019. Ranitidine recall.
[3] MarketWatch, 2022. Acid Suppressants Market Trends.