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 thirty-nine 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

International Patents for PEPCID AC

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

Country	Patent Number	Title	Estimated Expiration
South Korea	830002478
Japan	H01207068	DOUBLE IMMERSION OF GELATIN COATED TABLET
Yugoslavia	42966
Japan	H06316536	TASTE-MASKING AND SUSTAINED-RELEASE FILM FOR MEDICINE

PEPCID AC (famotidine): Market dynamics and financial trajectory

Last updated: April 25, 2026

What is PEPCID AC and where does it sit in the market?

PEPCID AC is the over-the-counter (OTC) brand of famotidine, an oral H2-receptor antagonist (H2RA) for the treatment of heartburn and other symptoms of acid indigestion (GERD-related symptoms). The drug’s competitive set is dominated by:

• PPIs (e.g., omeprazole/esomeprazole/lansoprazole), which generally deliver stronger acid suppression for frequent GERD
• H2 blockers (famotidine vs. cimetidine and other H2 brands, where present)
• Antacids and combination products (calcium carbonate, aluminum/magnesium hydroxides, alginates in some markets)

Implication for market structure: OTC acid-suppression is a scale and retail-visibility business. Famotidine’s market position typically tracks (1) consumer preference for fast symptom relief, (2) substitution toward PPIs for frequent or persistent symptoms, and (3) pricing and promotional intensity in mass retail and pharmacy channels.

How do consumer behavior and competitor actions drive demand?

1) Symptom severity drives switching between H2RA and PPI

OTC consumers self-select based on perceived frequency and intensity:

• Occasional heartburn tends to favor H2RA products like famotidine.
• Frequent or persistent symptoms tend to push consumers toward OTC PPIs after early use of H2RA or antacids.

This generates a typical dynamic: famotidine demand is more sensitive to “occasional use” cohorts, while PPIs capture more of the “ongoing control” cohort once consumers trade up.

2) Promotion and shelf strategy determine short-cycle performance

OTC acid products face high turnover per retail planogram and frequent price changes. Execution variables that move unit share:

• Shelf presence in pharmacy and mass channels
• Couponing and multi-buy promotions
• Pack-size strategy (day supply, tablet count)
• Margin allocation between manufacturer, retailer, and wholesalers

Famotidine’s market outcomes typically reflect brand spending and trade strategy more than differentiation, because H2RA products deliver broadly comparable pharmacology across labeled indications.

3) Generics pressure is structurally persistent

Famotidine is widely available as a generic. For OTC brand owners, the financial trajectory is shaped by:

• Brand-to-generic price gap
• Ability to hold retail share through promotions
• Substitution away from branded SKUs when consumer value perception shifts

In this segment, branded OTC performance tends to flatten when generics compress the price differential, unless the brand sustains strong trade spending and consumer loyalty.

What market tailwinds and headwinds are present for famotidine OTC?

Tailwinds

• Large base of patients using OTC for episodic symptoms (broad demographic coverage)
• Familiarity and long-term brand recognition (brand-led choice over time)
• Broad tolerance profile for OTC self-management, supporting repeat use

Headwinds

• PPI substitution for frequent GERD symptoms
• Generic pricing pressure
• Market maturity: limited new differentiation once generic availability is established

How does PEPCID AC typically move through the year in revenue terms?

OTC acid products often show:

• Higher sales during periods when consumers stock up and promotions run (retail calendar effects)
• Seasonal uplift in some years tied to travel, diet changes, and holiday food patterns
• Steady baseline from chronic “occasional reflux” use even when seasonal demand moderates

For a mature OTC category, the key variable is not new patient adoption; it is share of symptom-experienced consumers at the point of purchase.

What is the financial trajectory you should expect for PEPCID AC?

A precise multi-year revenue curve requires company segment reporting, retail scanner data, and brand-level financial disclosures. Those specifics are not provided here. What can be stated from category mechanics is the typical trajectory shape for a long-standing branded OTC H2RA once generic penetration is entrenched:

1. Mid-cycle share stabilization driven by brand trade programs
2. Gradual margin compression as generics narrow the price gap
3. Revenue growth that is mostly volume and trade-driven, not price-driven
4. Volatility around promotion intensity, with periods of share gains followed by normalization

In investor terms, the segment’s financial model is usually:

• Revenue: depends on maintaining retail share versus PPI substitution and generics
• Gross margin: pressured by trade spending and competitive pricing
• Operating performance: benefits when promotional intensity can be optimized without losing share

Where are the risk points to the PEPCID AC revenue outlook?

The main risk vectors map to category substitution and trade economics:

• If OTC PPI share gains persist, H2RA unit demand faces structural pressure.
• If retail price competition escalates, branded PEPCID AC faces faster margin erosion.
• If trade spend increases without net share gains, profits compress faster than revenue.

How do regulatory and labeling realities affect OTC performance?

OTC acid products are shaped by:

• Labeled indication boundaries and consumer expectations
• Advertising restrictions and compliance requirements
• Claims standardization across competitors

In practice, PEPCID AC’s financial trajectory is driven less by regulatory discontinuities and more by competitive substitution and retail economics.

What actions matter most for forecasting PEPCID AC performance?

For a brand like PEPCID AC, near-to-mid-term forecasting centers on these measurable levers:

• Retail share versus PPI and antacids
• Price per unit (net of trade) vs. generic and PPI alternatives
• Promo cadence and depth (events per quarter, discount structure)
• Pack mix shifts (day-supply, tablet count, value packs)

A model built from those variables typically explains category outcomes better than assumptions about medical innovation, since the drug’s role is established and differentiation is limited.

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Key Takeaways

• PEPCID AC (famotidine) operates in a mature OTC acid-suppression market where demand tracks occasional heartburn cohorts and is pressured by PPI substitution and generic price competition.
• Revenue trajectory is trade- and share-led, with margin compression risk when branded price premiums shrink.
• The most material forecast inputs are retail share, net price after trade, promo intensity, and pack mix, not changes in clinical utility.

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FAQs

1) What class of drug is PEPCID AC?

PEPCID AC is famotidine, an H2-receptor antagonist (H2RA).

2) Who are PEPCID AC’s main OTC competitors?

The primary OTC competitive set is OTC PPIs, other acid-suppression options, and antacids in retail channels.

3) Does generic famotidine affect PEPCID AC?

Yes. Generic availability compresses pricing power and increases substitution risk.

4) What drives short-term PEPCID AC sales?

Short-cycle results mostly reflect retail execution and promotional strategy, including price, coupons, and pack mix.

5) Is PEPCID AC positioned for frequent GERD symptoms?

OTC behavior typically pushes frequent or persistent symptoms toward PPIs, while H2RA products like famotidine tend to capture more occasional use.

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References

[1] U.S. Food and Drug Administration. OTC Drug Facts Labeling: Antacids, Acid Reducers, and Protectants. FDA. https://www.fda.gov/ (accessed via publicly available FDA OTC labeling resources).
[2] U.S. National Library of Medicine. Famotidine drug information (MedlinePlus). https://medlineplus.gov/ (accessed via publicly available drug monographs).