PEPCID AC Drug Patent Profile

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

Pepcid Ac is a drug marketed by Kenvue Brands and J And J Consumer Inc and is included in three NDAs.

The generic ingredient in PEPCID AC 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 Ac

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

Summary for PEPCID AC

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	35
What excipients (inactive ingredients) are in PEPCID AC?	PEPCID AC excipients list
DailyMed Link:	PEPCID AC at DailyMed

Recent Clinical Trials for PEPCID AC

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 AC clinical trials

Pharmacology for PEPCID AC

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

US Patents and Regulatory Information for PEPCID AC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kenvue Brands	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998		DISCN	Yes	No
Kenvue Brands	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995		OTC	Yes	No
Kenvue Brands	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-002	Dec 17, 2007		OTC	Yes	Yes
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999		DISCN	No	No
Kenvue Brands	PEPCID AC	famotidine	TABLET;ORAL	020325-002	Sep 23, 2003		OTC	Yes	Yes

Expired US Patents for PEPCID AC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999
Kenvue Brands	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995
Kenvue Brands	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999
Kenvue Brands	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995

International Patents for PEPCID AC

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

Country	Patent Number	Title	Estimated Expiration
Spain	489222
Spain	2075341
Netherlands	7909321
Denmark	0448231
Australia	639334

Market Dynamics and Financial Trajectory for Peptic Acid Drug: PEPCID AC

Last updated: August 1, 2025

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Introduction

Peptic acid suppression remains a key therapeutic sector within gastrointestinal (GI) medicine, addressing conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Among the longstanding medications, Pepto-Bismol, Omeprazole, and Pepcid AC (famotidine) occupy prominent market positions. This analysis concentrates on Pepcid AC, an over-the-counter (OTC) formulation of famotidine, elucidating its market dynamics and projected financial trajectory amid evolving consumer preferences, regulatory shifts, and competitive landscapes.

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Product Overview and Historical Context

Pepcid AC is an antacid and H2 receptor antagonist (H2RA), widely used for relief of heartburn, indigestion, and acid reflux. Introduced in the 1980s, famotidine distinguished itself from proton pump inhibitors (PPIs) through rapid onset and favorable safety profile, particularly for OTC use. Its popularity persisted due to minimal drug interactions and affordability, historically capturing a significant market share.

However, the landscape changed with the advent of PPIs, which exhibit higher potency for acid suppression. Notwithstanding, famotidine maintained relevance due to its OTC status, safety profile, and recent resurgence driven by safety concerns associated with PPIs.

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Market Dynamics

a. Regulatory Landscape and Safety Concerns

The safety profile of famotidine faced scrutiny after reports of potential carcinogenic impurities—N-nitrosodimethylamine (NDMA)—detected in some formulations. Regulatory agencies, notably the U.S. Food and Drug Administration (FDA), issued recalls and guidance, prompting reformulation and increased quality control measures. This regulatory awakening temporarily constrained market growth but also created opportunities for manufacturers to innovate safer, compliant formulations.

Additionally, the withdrawal or restriction of certain PPIs due to long-term safety concerns has shifted consumer preference back towards H2RAs like famotidine. The FDA’s 2020 recall of ranitidine (Zantac) due to NDMA contamination further bolstered famotidine's position as a safer alternative.

b. Consumer Preferences and Market Trends

Consumer demand has evolved toward trusted and proven medications, especially amid heightened health awareness. The increasing incidence of GERD related to obesity, dietary habits, and the COVID-19 pandemic-induced lifestyle shifts has sustained demand for acid-suppressing drugs. OTC availability enhances accessibility and drives sales growth, especially in retail pharmacies, supermarkets, and online platforms.

Nevertheless, competition from PPIs (e.g., omeprazole, esomeprazole) remains intense due to their superior potency. Still, famotidine’s value proposition—cost-effectiveness, safety, OTC access—preserves its market niche.

c. Competitive Landscape

Market players include Johnson & Johnson (with initial PEPCID formulations), MediNatura, and various generics manufacturers. Patent expirations have facilitated a proliferation of generic famotidine products, intensifying price competition and pressuring margins.

Recent innovations include higher-dose formulations and combination OTC products aimed at addressing broader GI symptoms. The COVID-19 pandemic has accelerated virtual health consultations influencing prescription and OTC sales channels.

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Financial Trajectory and Market Forecast

a. Revenue Trends and Market Size

The global peptic ulcer and reflux disorder drugs market was valued at approximately $14 billion in 2022, with H2RAs like famotidine constituting a substantial segment (~$2–3 billion). OTC famotidine products, including Pepcid AC, account for a significant share of this segment owing to their widespread OTC availability.

Post-2019, the market experienced a modest decline attributable to the competition from PPIs and safety concerns. However, Revitalization in demand has been observed since 2021, driven by increased consumer confidence and safety reassurance measures.

b. Impact of Patent Expirations and Generics

Patent expiration of branded Pepcid in the early 2000s prompted generic proliferation, significantly reducing prices and margins but expanding volume sales. The entrance of multiple generics has sustained overall revenue streams, although profit margins for manufacturers have flattened.

c. Projected Growth Drivers

• Increased prevalence of GI disorders: Rising obesity rates, dietary habits, and aging populations will sustain demand.
• Regulatory easing: Changes favoring OTC availability and the elimination of safety concerns could boost sales.
• Digital health channels: Online pharmacies and telemedicine services facilitate OTC sales, especially among younger demographics.
• Product reformulation and innovation: Safer, higher-dose, or combination products could unlock new revenue streams.

d. Challenges and Risks

• Shift toward PPIs: The superior efficacy of PPIs restricts famotidine growth, especially in prescription segments.
• Safety recalls: Potential NDMA contamination questions necessitate rigorous testing, potentially increasing costs.
• Regulatory restrictions: Further limitations on OTC sales could hinder demand.

e. Financial Outlook (2023–2028)

Considering current trends, the market for OTC famotidine is expected to grow at a compound annual growth rate (CAGR) of 2-4% over the next five years. This moderate growth reflects stabilization after past declines and resilience driven by safety perceptions and consumer preferences.

New formulations and expanded indications could marginally accelerate revenue growth, but notable gains depend on regulatory environments and competitive innovations.

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Strategic Implications for Stakeholders

• Manufacturers should prioritize quality assurance and safety compliance to maintain consumer trust.
• Pharmaceutical companies may explore formulation enhancements to differentiate products.
• Distributors should leverage digital channels to capitalize on rising OTC sales.
• Regulatory agencies will influence market behavior through ongoing safety monitoring and guidelines.

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Key Takeaways

• Market resilience: Pepcid AC remains a resilient OTC GI therapy amidst PPI dominance and safety concerns.
• Competitive pressure: Generics and new formulations constrain margins but expand market size.
• Regulatory impact: Safety recalls and reformulation requirements influence product availability and consumer confidence.
• Growth opportunities: Driven by increasing GI disorder prevalence, product innovation, and digital sales channels.
• Risk mitigation: Ensuring compliance with quality standards is critical to sustain market share.

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Conclusion

Pepcid AC, as a leading famotidine-based OTC medication, exhibits a stable yet competitive market trajectory. While challenges from lower-cost generics and potent PPIs persist, safety concerns and shifting consumer preferences favor famotidine's continued relevance. The future landscape hinges on regulatory developments, innovation in formulation, and strategic positioning within the GI therapeutics sector.

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FAQs

1. How does Pepcid AC compete with proton pump inhibitors (PPIs)?
Pepcid AC (famotidine) offers rapid relief with a favorable safety profile but is less potent than PPIs. Its OTC availability and safety appeal sustain its niche, especially for mild to moderate symptoms. PPIs dominate in severe cases requiring potent acid suppression.

2. What regulatory issues have influenced Pepcid AC's market?
Concerns over NDMA contamination led to recalls and reformulations, impacting supply chains. Regulatory agencies' emphasis on safety standards may further influence future formulations and over-the-counter accessibility.

3. Will OTC availability of famotidine increase in the future?
Likely, especially with safety confidence restored and innovations in formulations. Regulatory agencies recognizing its safety profile could facilitate broader OTC access.

4. How has the COVID-19 pandemic impacted paiid acid medication sales?
The pandemic heightened health awareness and increased demand for OTC medications, including Pepcid AC, to manage acid-related discomfort during prolonged indoor stays and dietary changes.

5. What are the key growth areas for famotidine?
Innovation in safer formulations, leveraging digital sales channels, and expanding indications for GI-related symptoms present growth opportunities.

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References

[1] Market Data Forecast. (2022). Gastrointestinal Drugs Market Size & Share.

[2] FDA. (2020). Recall of Ranitidine (Zantac) due to Nitrosamine impurities.

[3] Grand View Research. (2023). Gastrointestinal Therapeutics Market Analysis.

[4] IQVIA. (2023). OTC Gastrointestinal Medications Sales Data.

[5] BCG. (2022). Impact of Safety Concerns on Acid Suppression Therapy.