Last Updated: August 3, 2026

PEPCID AC Drug Patent Profile


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Which patents cover Pepcid Ac, and when can generic versions of Pepcid Ac launch?

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-six 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 16th, 2001.

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Summary for PEPCID AC
US Patents:0
Applicants:2
NDAs:3

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Kenvue Brands PEPCID AC famotidine TABLET;ORAL 020325-001 Apr 28, 1995 OTC Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Kenvue Brands PEPCID AC famotidine TABLET, CHEWABLE;ORAL 020801-002 Dec 17, 2007 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: April 25, 2026

PEPCID AC (famotidine) Investment Scenario and Fundamentals Analysis

What is PEPCID AC and how does it fit the branded and OTC market?

PEPCID AC is a brand of famotidine, an oral H2-receptor antagonist (H2RA) used for heartburn/acid indigestion and related symptoms. The product is sold both as OTC (notably in the US as PEPCID AC) and historically under prescription branded channels in some markets. Investment relevance comes from whether the brand is positioned as (1) a durable OTC cash flow asset and (2) a defensible platform against competitive OTC acid-reduction options.

Core drug class economics

  • Mechanism: competitive inhibition of histamine H2 receptors on gastric parietal cells, reducing gastric acid secretion.
  • Competitive set:
    • OTC PPIs (e.g., omeprazole, esomeprazole, lansoprazole where available OTC)
    • OTC H2 blockers (famotidine competitors, different brands/generics)
    • OTC antacids (calcium carbonate, magnesium/aluminum hydroxide)
  • Category dynamic: OTC acid reducers face substitution pressure. Long-term value tends to come from distribution strength, formulation and brand loyalty, and incremental line extensions (dose forms, pack configurations), not from pipeline differentiation.

What does the supply-and-cost structure imply for margins?

Famotidine is an established small-molecule with long patent history behind it in many jurisdictions. The investment case for a specific brand therefore depends on brand-level pricing power and trade spend discipline rather than API scarcity or technology barriers.

Typical brand economics for mature OTC

  • Cost of goods: dominated by generic-grade or commoditized API and packaging.
  • Gross margin: supported by brand and channel pricing, but constrained by OTC category competitive intensity and retailer promotions.
  • Operating levers: marketing investment, pharmacy and mass channel placement, pack architecture, and trade terms.

Business implication

  • PEPCID AC functions less like a “drug discovery asset” and more like an OTC brand/consumer product. Predictability is tied to category demand stability and share maintenance, not to regulatory milestones.

How does the OTC competitive landscape affect expected demand?

OTC heartburn and acid indigestion treatments are a volume market with multiple substitutes.

Competitive substitution map for investor modeling

  • H2RA vs PPI: PPIs tend to be preferred for frequent or persistent symptoms; H2RAs often retain share for intermittent use, tolerability, and price positioning.
  • H2RA vs antacids: antacids capture breakthrough relief use cases; H2RAs capture longer symptom control.
  • Brand vs generic H2RA: the central risk is OTC generics of famotidine compressing pricing and increasing promotion intensity.

What to monitor

  • Shelf share and planogram presence by channel (drugstores vs mass vs online).
  • Promotion cadence (couponing, multi-pack discounts).
  • Net revenue per unit vs volume trends, which reveal whether PEPCID AC holds value or sells mainly through price.

What is the investment scenario for PEPCID AC under mature-drug fundamentals?

A realistic scenario set for PEPCID AC is driven by four fundamentals:

1) Category size stability

  • Heartburn prevalence is persistent, but treatment patterns shift across PPIs/H2RAs. 2) Share retention vs erosion to generics and PPIs
  • Brand performance is sensitive to retailer switching to lower-priced famotidine options. 3) Trade spend and compliance costs
  • OTC brands face ongoing marketing requirements to defend share. 4) Product lifecycle
  • Without new patent-protected formulation improvements, long-term upside is limited to incremental line extensions and efficiency gains.

Base-case logic

  • Mature OTC small molecules usually deliver steady cash flows with limited upside.
  • Upside requires either (a) sustained brand premium vs generic famotidine, or (b) a favorable mix shift (higher dose strength usage, value packs, or stronger online sales).

Downside logic

  • Net revenue declines can occur even if unit volume holds, if promotions increase or if consumers trade to cheaper generics or stronger-perceived PPIs.

What are the key fundamentals to build an investment model around?

For a brand like PEPCID AC, build the model around brand-level operating metrics rather than pipeline KPIs.

Demand and share

  • OTC category volume for acid reducers
  • PEPCID AC unit share across key channels
  • Average selling price (ASP) vs promotional intensity
  • Online sales mix (often higher margin or different cost structure)

Pricing and margin drivers

  • Net revenue per pack under retailer contracts
  • Gross margin after trade deductions
  • Marketing efficiency (spend per incremental unit)
  • COGS per unit and packaging cost inflation

Regulatory and labeling stability

  • H2RA OTC labeling changes can shift marketing effectiveness and consumer guidance.
  • Label clarity affects conversion from “symptom awareness” to “brand purchase.”

Does PEPCID AC face any specific clinical or safety narrative risk?

Famotidine’s clinical history is long. For investment analysis, the main issue is whether consumer and prescriber perception changes due to safety narratives, recalls, or formulation disputes. Such events typically influence short-term demand and retailer willingness to stock.

Operational risk categories

  • Supply disruptions (API or finished product)
  • Retail recall or packaging issues
  • Safety communications that change consumer trust

Investor use

  • Treat these as event-risk overlays on otherwise stable OTC demand rather than structural impairment unless sustained.

What is the patent and exclusivity context that constrains upside?

Famotidine is off-patent in many markets, so a brand like PEPCID AC generally does not have ongoing exclusivity based on the active ingredient. Investment upside typically depends on:

  • brand trademark strength,
  • line extensions not covered by current competition intensity,
  • market-specific regulatory exclusivity for particular dosage forms only if present (rare for older actives at this stage),
  • and execution (trade, marketing, distribution).

Practical consequence

  • Traditional R&D-style value creation is limited. Returns rely on brand management and category positioning, not new intellectual property.

How should investors benchmark PEPCID AC against OTC acid reducer peers?

Use a like-for-like framework across the OTC category. The goal is to identify whether PEPCID AC outperforms on net revenue durability or share stability.

Peer benchmarks (conceptual)

  • H2RA leader brands vs private label famotidine
  • OTC PPI brands vs OTC H2RA brands on net revenue growth and promotional intensity
  • Antacid categories as a “fallback” for consumers seeking short relief

Metrics

  • Unit share trend (quarters)
  • Net revenue growth vs category growth
  • Promotional intensity impact on net pricing
  • Margin stability under trade pressure

What is the actionable investment thesis structure for PEPCID AC?

A grounded thesis for PEPCID AC in a mature OTC market should follow this template:

Thesis (base case)

  • PEPCID AC produces stable OTC cash flows supported by persistent heartburn demand.
  • The brand sustains revenue through channel distribution and brand trust.
  • Upside is modest and comes from mix improvement (pack formats, online strength) and trade spend efficiency.

Primary risks

  • Price erosion from OTC generics and private label.
  • Share loss to OTC PPIs and to antacid-driven purchase patterns.
  • Retail promotion escalation that compresses net pricing and margins.
  • Event-risk disruptions (supply or safety communications).

Catalysts (execution-based rather than scientific)

  • Measurable share gains in targeted channels.
  • Evidence that net pricing remains resilient versus generic competitors.
  • Improved gross margin through COGS stabilization and reduced promotional intensity.

Key Takeaways

  • PEPCID AC is a mature OTC H2-receptor antagonist brand where investment returns depend primarily on brand execution, pricing discipline, and share retention, not on new drug innovation.
  • In the acid-reducer OTC market, substitution pressure from PPIs and generics is structurally persistent; the decisive variable is whether PEPCID AC holds net revenue per unit without excessive promotion.
  • The most actionable model is a brand P&L view: units, ASP/net pricing after trade, gross margin after promotions, and marketing efficiency by channel.
  • Patent-driven upside is limited; the practical path to outperformance is channel and mix strength plus trade spend control.

FAQs

1) Is PEPCID AC primarily a growth story or a cash-flow story?

It is primarily a cash-flow and share-stability story in a mature OTC category, with growth constrained by generic substitution and PPI competition.

2) What drives PEPCID AC revenue most: unit volume or pricing?

Both matter, but in a promotional OTC environment, investors should weigh net pricing resilience heavily. Brand performance often hinges on holding value as promotions rise.

3) What are the main competitive threats to PEPCID AC?

The main threats are OTC PPIs, lower-priced famotidine generics/private label, and antacids that capture symptom-breakthrough purchases.

4) What investment metrics should be tracked quarterly?

Track unit share, net revenue per pack, promotional intensity, gross margin after trade, and marketing spend efficiency by channel.

5) What kind of “catalysts” apply to PEPCID AC?

Catalysts are typically execution-based: retailer contract outcomes, online mix shifts, pack format changes, and measurable reductions in promotion intensity that preserve net pricing.


References

[1] U.S. Food and Drug Administration (FDA). Drug Products and Information: Famotidine (labeling and references for active ingredient use). https://www.accessdata.fda.gov/scripts/cder/daf/
[2] National Library of Medicine (NLM), MedlinePlus. Famotidine: Information on uses and guidance for heartburn/acid indigestion. https://medlineplus.gov/

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