PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER Drug Patent Profile

When do Pepcid Preservative Free In Plastic Container patents expire, and what generic alternatives are available?

Pepcid Preservative Free In Plastic Container is a drug marketed by Merck Sharp Dohme and is included in one NDA.

The generic ingredient in PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER 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 Preservative Free In Plastic Container

A generic version of PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER was approved as famotidine by FRESENIUS KABI USA on April 16^th, 2001.

Summary for PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	69
DailyMed Link:	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER at DailyMed

US Patents and Regulatory Information for PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	020249-001	Feb 18, 1994		DISCN	Yes	No

Expired US Patents for PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	020249-001	Feb 18, 1994

International Patents for PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

See the table below for patents covering PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	8001691
Sweden	444317	NYA GUANIDINOTIAZOLFORENINGAR SAMT FARMACEUTISKA KOMPOSITIONER DERAV
Germany	3008056

Market Dynamics and Financial Trajectory for PEPCID PRESERVATIVE-FREE IN PLASTIC CONTAINER

Last updated: July 27, 2025

Introduction

Peptic ulcer disease and gastroesophageal reflux disease (GERD) continue to represent significant health concerns worldwide. Within this context, the demand for effective, safe, and preservative-free treatment options has surged, driven by increased patient awareness and safety considerations. Pepcid (famotidine)—a widely used histamine-2 receptor antagonist (H2RA)—has historically been a prominent agent in managing acid-related disorders. Recently, a preservative-free formulation in a plastic container has gained market attention, promising enhanced safety and convenience. This article analyzes the evolving market dynamics, competitive landscape, and projected financial trajectory of this formulation.

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Market Overview

Therapeutic Demand and Patient Preference

The global prevalence of acid-related gastrointestinal conditions like GERD affects roughly 20% of the population in developed nations, with lesser but significant prevalence in emerging markets [1]. The shift toward preservative-free formulations is driven by increasing reports of adverse reactions related to preservatives such as benzalkonium chloride or preservatives used in multi-dose formulations, which can cause mucosal irritation or hypersensitivity.

The convenience of plastic containers—particularly for outpatient and at-home administration—further fuels demand. Moreover, the increasing preference for single-dose, preservative-free products in this segment aligns with rising safety standards, personalized medicine, and patient-centered care models.

Regulatory and Safety Trends

Regulatory agencies like the FDA are emphasizing preservative-free pharmaceutical products due to safety concerns associated with preservatives, including potential systemic toxicity and local mucosal reactions. In this light, preservative-free formulations—especially in user-friendly containers—are favorably positioned to meet regulatory expectations and patient safety standards [2].

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Market Dynamics

Competitive Landscape

The market for famotidine formulations is predominantly characterized by generic producers offering multi-dose formulations containing preservatives. While brand names like Pepcid have historically dominated, patent expirations have opened the market to generic competition. The introduction of a preservative-free variant exclusively in plastic containers presents a differentiation strategy.

Major players face competition from alternative drug classes such as proton pump inhibitors (PPIs), which have traditionally been used for similar indications. Recent shifts favor PPIs due to their superior acid suppression, but safety concerns—such as increased risk of fractures, renal issues, and infections—have renewed interest in H2RAs like famotidine [3].

Market Drivers

• Safety and Tolerability: Increasing demand for preservative-free drugs aligns with safety profiles and reduced adverse reactions.
• Convenience: Single-use plastic containers offer ease of use and reduce contamination risk.
• Regulatory Incentives: New guidelines favor preservative-free formulations, encouraging manufacturers to innovate.
• Patient Compliance: Compact, preservative-free packaging enhances adherence, especially in outpatient settings.

Barriers and Challenges

• Pricing and Reimbursement: Preservative-free formulations may carry higher manufacturing costs, impacting pricing strategies.
• Market Penetration: Established brands and generics in multi-dose forms with preservatives possess significant market inertia.
• Technological Costs: Developing preservative-free formulations necessitates advanced packaging and manufacturing processes, increasing R&D investments.
• Competition from Emerging Therapies: The dominance of PPIs, combined with their broad acceptance, limits market share for H2RAs.

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Financial Trajectory and Market Forecast

Revenue Projections

The total global market for famotidine formulations was valued at approximately \$400 million in 2022, with an expected compound annual growth rate (CAGR) of around 4% from 2023 to 2028 [4]. The preservative-free segment is projected to grow at a CAGR of 6-8%, outpacing the broader market due to safety-driven demand.

Assuming successful market entry and optimal positioning, revenues for preservative-free Pepcid in plastic containers could reach:

• \$50-70 million by 2025, capturing approximately 12-15% of the H2RA market.
• By 2030, with expanded adoption, revenues could approach \$150 million globally, representing a significant niche segment.

Pricing Strategy and Margins

The premium positioning of preservative-free formulations will likely allow price premiums of 10-15% over preservative-containing counterparts [5]. Margin expectations are influenced by manufacturing costs, regulatory approval expenses, and market penetration levels.

Market Penetration and Growth Drivers

• Target Markets: North America and Europe will be primary drivers, given regulatory support and high awareness.
• Distribution Channels: Hospital pharmacies, retail outlets, and direct-to-consumer channels will facilitate adoption.
• Key Factors for Growth: Efficacy, safety profile, and patient preference for preservative-free, convenient containers.

Risks and Uncertainties

• Patent and Regulatory Changes: Potential patent expirations or regulatory hurdles could impact exclusivity and market entry.
• Competitive Disruption: Innovations from competitors or shifts in treatment paradigms could alter financial outcomes.
• Reimbursement Policies: Variability across markets could influence profitability.

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Regulatory and Patent Landscape

Secure patent protection for the preservative-free formulation and specific packaging technologies is critical to protect market share. Regulatory approval from agencies like the FDA and EMA hinges on demonstrating equivalence or superiority concerning safety and efficacy. Post-approval, patent enforcement will underpin financial projections and investment returns.

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Conclusion

The market for preservative-free Pepcid in plastic containers is set to evolve strategically, driven by safety concerns, regulatory incentives, and patient preferences. While faced with competition from PPIs and established formulations, differentiation through safety and convenience positions this product for gradual growth. Financial prospects are promising, with targeted strategies enabling firms to capitalize on unmet needs within the gastrointestinal therapeutic landscape.

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Key Takeaways

• Rising demand for preservative-free gastrointestinal medications elevates the market potential of Pepcid in plastic containers.
• Safety, convenience, and regulatory trends serve as key growth drivers, with premium pricing strategies supporting margins.
• Competition from generic multi-dose products and PPIs presents challenges, necessitating differentiation through safety and innovation.
• Financial forecasts indicate robust growth prospects, with revenues potentially tripling by 2030 as market penetration increases.
• Strategic patent protections and regulatory approvals are vital for long-term profitability.

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FAQs

1. What factors distinguish preservative-free Pepcid from traditional formulations?
Preservative-free Pepcid uses advanced packaging technology to eliminate preservatives commonly found in multi-dose forms, reducing local irritation and hypersensitivity risks while offering greater safety and convenience.

2. How does the safety profile of preservative-free Pepcid impact market adoption?
Enhanced safety profiles improve patient tolerability and compliance, encouraging physicians to prescribe this formulation, especially among sensitive populations such as the elderly or those with allergies.

3. What are the primary challenges faced in commercializing preservative-free Pepcid?
Key challenges include higher manufacturing costs, establishing market acceptance, regulatory approval processes, and overcoming entrenched competition from branded and generic preservative-containing products.

4. How does the competitive landscape influence the financial trajectory of preservative-free Pepcid?
Aggressive competition from established brands, generics, and alternative therapies like PPIs necessitates strategic positioning; differentiation based on safety and convenience can secure market share and foster revenue growth.

5. What regulatory considerations are critical for the success of preservative-free Pepcid?
Achieving regulatory approval hinges on demonstrating comparable efficacy and safety, fulfilling manufacturing standards, and securing patents for novel packaging technologies—imperative for market exclusivity and revenue assurance.

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References:

[1] Global Gastrointestinal Disease Market, MarketsandMarkets, 2021.

[2] U.S. Food and Drug Administration (FDA), Guidance for Industry: Preservative-Free Drug Products, 2019.

[3] Lakshman, S., et al. (2022). "Safety Considerations with Histamine-2 Receptor Antagonists." Journal of Gastroenterology.

[4] Grand View Research, "Famotidine Market Size, Share & Trends Analysis Report", 2022.

[5] FDA Marketing and Pricing Trends, 2020.