PEPCID COMPLETE Drug Patent Profile

When do Pepcid Complete patents expire, and when can generic versions of Pepcid Complete launch?

Pepcid Complete is a drug marketed by Kenvue Brands and is included in one NDA.

The generic ingredient in PEPCID COMPLETE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for PEPCID COMPLETE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	35
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PEPCID COMPLETE
What excipients (inactive ingredients) are in PEPCID COMPLETE?	PEPCID COMPLETE excipients list
DailyMed Link:	PEPCID COMPLETE at DailyMed

Recent Clinical Trials for PEPCID COMPLETE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 2/Phase 3
United States Department of Defense	Phase 2
Leidos Life Sciences	Phase 2

See all PEPCID COMPLETE clinical trials

Pharmacology for PEPCID COMPLETE

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

Paragraph IV (Patent) Challenges for PEPCID COMPLETE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PEPCID COMPLETE	Chewable Tablets	calcium carbonate; famotidine; magnesium hydroxide	800 mg/10 mg/ 165 mg (OTC)	020958	1	2004-11-01

US Patents and Regulatory Information for PEPCID COMPLETE

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 COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000		OTC	Yes	Yes

Expired US Patents for PEPCID COMPLETE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	4,283,408*PED
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	5,989,588*PED
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	5,817,340*PED
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	5,075,114*PED

International Patents for PEPCID COMPLETE

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

Country	Patent Number	Title	Estimated Expiration
Spain	8103070
Spain	8100281
South Korea	830002478
Spain	2088550

Supplementary Protection Certificates for PEPCID COMPLETE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2957286	1990003-4	Sweden		PRODUCT NAME: PATRIOMER SORBITEX CALCIUM; REG. NO/DATE: EU/1/17/1179 20170721
2957286	2018/046	Ireland		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	2018C/047	Belgium		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
2957286	122018000145	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719

Market Dynamics and Financial Trajectory for PEPCID COMPLETE

Last updated: July 29, 2025

Introduction

PEPCID COMPLETE, a combination over-the-counter (OTC) medication designed to treat gastroesophageal reflux disease (GERD), heartburn, and acid indigestion, occupies a significant niche within the broader gastrointestinal (GI) therapeutics market. Its formulation merges famotidine—a potent H2 receptor antagonist—with antacids such as calcium carbonate and magnesium hydroxide, providing rapid and sustained relief. Analyzing its market dynamics and financial trajectory involves understanding consumer behavior, regulatory environment, competitive landscape, manufacturing considerations, and macroeconomic influences shaping its growth prospects.

Market Overview and Consumer Demographics

The global GI therapeutics market, valued at approximately $18 billion in 2022, is driven by increasing prevalence of GERD, rising incidences of acid-related disorders, and consumer preference for OTC solutions. PEPCID COMPLETE benefits from a broad demographic profile, serving both adult populations seeking quick relief and older adults managing chronic reflux issues.

The shift from prescription to OTC formulations for acid suppression therapy has expanded accessibility, fostering an uptick in consumer adoption. Notably, the United States remains the largest market, owing to high awareness, flexible healthcare policies, and established OTC channels, followed by Europe and parts of Asia.

Competitive Landscape

PEPCID COMPLETE operates amidst a competitive environment featuring:

• Brand Competitors: Ranitidine, omeprazole (proton pump inhibitors—PPIs), and other H2 blockers like cimetidine.
• Generic Alternatives: A proliferation of generic famotidine and antacid products offering similar relief.
• Emerging Players: Newer formulations, including combination products with additional buffering agents and dietary supplements, aimed at differentiation.

The dominance of PPIs in recent years, driven by their longer-lasting acid suppression, has exerted pressure on H2 receptor antagonists like famotidine, although PEPCID COMPLETE retains a niche through its rapid-onset formulation and combination approach.

Regulatory and Patent Considerations

PEPCID COMPLETE gained OTC status following its initial prescription approvals. Patent expiration and the entry of generics have historically influenced pricing strategies and market share. Notably, the recall of ranitidine in 2019 due to carcinogenic impurities prompted consumers to shift toward famotidine-based products like PEPCID, benefiting its market position.

Regulatory pathways continue to evolve, with agencies prioritizing safety and efficacy. The potential for new formulations or indications requires close monitoring to forecast future approvals or restrictions.

Market Drivers

• Growing Incidence of GERD and Acid-related Disorders: Lifestyle factors, obesity, and aging populations contribute to increasing demand.
• Consumer Preference for OTC Medications: Preference for readily accessible, self-managed treatments bolsters sales.
• Product Innovation: Combination formulations addressing immediate and sustained relief are attractive to consumers.
• Healthcare Cost Savings: OTC options reduce healthcare burdens by decreasing prescription reliance.

Market Challenges

• Competition from PPIs: Longer-lasting acid suppression from PPIs like omeprazole limits lubrification for H2 antagonists.
• Generic Price Erosion: The entry of generics compresses margins.
• Regulatory Changes: Stricter safety assessments could impact formulations or marketing.
• Consumer Perception and Education: Misinformation about efficacy and safety may hinder growth.

Financial Trajectory and Revenue Trends

PEPCID COMPLETE's revenue trajectory reflects robustness amid competitive pressures. Market analysts project a compound annual growth rate (CAGR) of approximately 4-6% for the OTC gastrointestinal segment over the next five years.

• Revenue Drivers:

  • Steady consumer demand for safe, effective OTC solutions.
  • Rapid market penetration in emerging economies through strategic partnerships.
  • Launch of new formulations or flavors to boost consumer appeal.

• Revenue Risks:

  • Price erosion from generic entries.
  • Regulatory hurdles delaying new product launches.
  • Market saturation in mature regions.

In terms of financial performance, PEPCID COMPLETE's manufacturer can expect margins to compress marginally, but volume growth driven by rising GERD prevalence and OTC acceptance mitigates this. Strategic investments in marketing, consumer education, and pipeline diversification will be critical for sustained growth.

Manufacturing and Supply Chain Dynamics

Ensuring product availability hinges on efficient manufacturing and robust supply chains:

• Raw Material Security: Sourcing of famotidine and antacids must navigate price fluctuations and geopolitical risks.
• Quality Assurance: Maintaining high-quality standards aligns with regulatory demands and consumer trust.
• Distribution Networks: Expanding global OTC distribution channels enhances access, especially in emerging markets.

Technological investments in formulation stability and packaging innovations further underpin supply chain resilience.

Macro and Microeconomic Influences

• Economic Conditions: Inflations and shifts in healthcare reimbursement policies impact consumer purchasing power and product affordability.
• Public Health Trends: The rising awareness of acid-related disorder management sustains demand, while COVID-19 pandemic disruptions temporarily affected supply chains but also heightened focus on self-care products.
• Digital Commerce: E-commerce growth facilitates direct-to-consumer sales, widening PEPCID COMPLETE's reach.

Strategic Outlook and Future Opportunities

To amplify revenue growth, manufacturers are exploring:

• Product Line Extensions: Introducing digestive health supplements and novel combination products.
• Global Expansion: Tailoring formulations and branding for Asian and Latin American markets.
• Data-Driven Marketing: Leveraging digital platforms to educate consumers about safety and efficacy.

Anticipated regulatory approvals for new indications or formulations could open additional revenue streams, especially in niche markets such as pregnancy-related reflux treatments.

Conclusion

PEPCID COMPLETE’s market influence is poised for steady growth, driven by demographic trends, consumer preferences for OTC solutions, and ongoing innovation. Challenges from generics and alternative therapies necessitate strategic product differentiation and market expansion initiatives. Continued focus on quality, consumer education, and global distribution will underpin its financial trajectory in the evolving GI therapeutics landscape.

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Key Takeaways

• The OTC GI market, valued at around $18 billion, provides a solid foundation for PEPCID COMPLETE’s growth prospects.
• Consumer demand driven by GERD prevalence, coupled with the shift toward OTC solutions, sustains revenue momentum.
• Competition from PPIs and generics remains a significant challenge, necessitating differentiation through innovation and marketing.
• Strategic global expansion and product pipeline diversification are vital for maintaining leadership in the evolving landscape.
• Regulatory developments and macroeconomic factors will shape future growth trajectories, emphasizing adaptability and operational agility.

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FAQs

1. How does PEPCID COMPLETE differentiate itself in the OTC GI market?
PEPCID COMPLETE combines famotidine with antacids, offering rapid symptom relief and sustained acid suppression, appealing to consumers seeking an all-in-one solution. Its formulation caters to those desiring immediate relief without the longer onset times associated with PPIs.

2. What are the main market risks for PEPCID COMPLETE?
Key risks include increased competition from generic products and PPIs, regulatory hurdles affecting formulation approvals, and pricing pressures from market saturation.

3. How significant is the role of emerging markets in the future growth of PEPCID COMPLETE?
Emerging markets represent substantial growth opportunities due to rising GERD prevalence, increasing healthcare awareness, and expanding OTC distribution channels.

4. What strategic actions can boost PEPCID COMPLETE’s market share?
Implementing product innovation, expanding global footprint, engaging in targeted consumer education, and leveraging digital sales channels are effective strategies.

5. What regulatory considerations could impact PEPCID COMPLETE’s trajectory?
Safety concerns, patent expirations, and approvals for new indications or formulations could influence its market presence and sales performance.

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Sources

1. MarketsandMarkets. Gastrointestinal Therapeutics Market Report, 2022.
2. Statista. Over-the-counter (OTC) gastrointestinal drugs market size, 2022.
3. FDA. Historical regulatory decisions related to famotidine and OTC drug approvals, 2021–2023.
4. IBISWorld. Gastroenterology pharmaceuticals global industry report, 2022.
5. Deloitte. Over-the-counter healthcare products: Trends and forecasts, 2022.