PEPCID Drug Patent Profile

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

Pepcid is a drug marketed by Salix Pharms, Merck, Bausch, J And J Consumer Inc, and Merck Sharp Dohme. and is included in nine NDAs.

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

Summary for PEPCID

US Patents:	0
Applicants:	5
NDAs:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	35
Patent Applications:	4,564
Drug Prices:	Drug price information for PEPCID
What excipients (inactive ingredients) are in PEPCID?	PEPCID excipients list
DailyMed Link:	PEPCID at DailyMed

See drug prices for PEPCID

Recent Clinical Trials for PEPCID

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 clinical trials

US Patents and Regulatory Information for PEPCID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987		DISCN	Yes	No
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995		OTC	Yes	No
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986		DISCN	Yes	No
Merck Sharp Dohme	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	020249-001	Feb 18, 1994		DISCN	Yes	No
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999		OTC	No	No

Expired US Patents for PEPCID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-001	Oct 15, 1986
Merck	PEPCID	famotidine	INJECTABLE;INJECTION	019510-001	Nov 4, 1986

International Patents for PEPCID

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

Country	Patent Number	Title	Estimated Expiration
Denmark	157132
U.S.S.R.	876056	METHOD OF PRODUCING GUANIDINOTHIAZOLE COMPOUNDS
Australia	5597580
Spain	8103070
Germany	3008056

PEPCID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Famotidine (PEPCID)

Introduction to Famotidine (PEPCID)

Famotidine, commonly known by the brand name PEPCID, is a widely used H2 receptor antagonist that plays a crucial role in treating various gastrointestinal disorders, including gastroesophageal reflux disease (GERD), peptic ulcer disease, Zollinger-Ellison syndrome, heartburn, and indigestion.

Market Size and Growth Projections

The famotidine market has been experiencing significant growth, driven by several key factors. As of 2023, the market size was valued at USD 6.7 billion and is projected to reach USD 13.5 billion by 2031, growing at a compound annual growth rate (CAGR) of 7.6% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Gastrointestinal Disorders

The rising incidence of gastrointestinal disorders such as GERD, peptic ulcers, and heartburn is a major driver of the famotidine market. These conditions are becoming more common due to lifestyle changes, increased stress, and the growing consumption of nonsteroidal anti-inflammatory drugs (NSAIDs)[3][4].

Preference for Over-the-Counter Remedies

There is a growing preference among consumers for efficient over-the-counter (OTC) remedies. Famotidine, being widely available in various formulations such as tablets, injections, and oral suspensions, caters to this demand effectively[1][5].

Advancements in Pharmaceutical Formulations

Ongoing research and development initiatives aimed at enhancing famotidine formulations and delivery systems are contributing to the market's growth. Innovations such as orally disintegrating tablets are making the drug more convenient and effective for patients[1][4].

Aging Population and Lifestyle Factors

The aging population is more prone to digestive problems, and the increasing awareness of gastrointestinal health among this demographic is driving the demand for famotidine. Additionally, lifestyle factors such as poor diet and increased stress levels are contributing to the rising incidence of gastrointestinal disorders[1][5].

Market Segmentation

The famotidine market is segmented based on application, product type, and geographical regions.

Application Segmentation

• Gastroesophageal Reflux Disease (GERD)
• Peptic Ulcer Disease
• Zollinger-Ellison Syndrome
• Heartburn
• Indigestion

These applications highlight the versatility and widespread use of famotidine in treating various gastrointestinal conditions[1].

Product Segmentation

• Famotidine Tablets
• Famotidine Injection
• Famotidine Oral Suspension

The availability of famotidine in different formulations caters to different patient needs and preferences[1].

Geographical Segmentation

The market is analyzed across various geographical regions including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The Asia-Pacific region is emerging as a significant market due to modernizing healthcare systems, rising healthcare spending, and the presence of prominent generic drug manufacturers in countries like India and China[1][4].

Competitive Landscape

The competitive environment of the famotidine market is characterized by several key players, including system integrators, middlemen, and end users. Major pharmaceutical companies such as AstraZeneca, GlaxoSmithKline (GSK), Pfizer Inc., Johnson & Johnson, and others are active in this market. The competitive dynamics are influenced by factors such as buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the level of competition[1][4].

Financial Performance and Investment

The financial performance of the famotidine market is robust, with significant investments in research and development. The market's growth is supported by the financial health of pharmaceutical companies, which invest heavily in R&D to enhance drug formulations and delivery systems. For instance, major pharmaceutical companies have invested nearly $15 billion in R&D and deployed more than $17 billion towards acquisitions, indicating a strong financial commitment to the sector[2].

Challenges and Opportunities

Challenges

• Generic Competition: The market faces challenges from generic versions of popular drugs going off-patent, leading to declining sales and profits for brand-name drugs[4].
• Proton Pump Inhibitors (PPIs): The development of PPIs has captured significant market share from H2 receptor antagonists, posing a competitive threat[4].
• Regulatory Processes: Strict regulatory processes increase the costs and time involved in drug development and approval, which can hinder market growth[4].

Opportunities

• Research and Development: Increased research and development activities to enhance famotidine formulations and explore new therapeutic areas present significant opportunities for growth[4].
• Emerging Markets: The Asia-Pacific region offers substantial growth opportunities due to its large patient population, modernizing healthcare systems, and rising healthcare spending[4].
• Generic Alternatives: The emergence of generic versions of famotidine contributes to market growth by increasing affordability and accessibility[5].

Market Trends

Shift Away from PPIs

There is a growing awareness of the long-term risks associated with PPIs, leading patients and medical providers to opt for famotidine due to its perceived safety profile and lower risk of side effects[5].

OTC Availability

The availability of famotidine as an OTC medication has significantly boosted its market demand, as it provides consumers with easy access to effective treatment for acid-related disorders[1][5].

Increasing Healthcare Spending

Rising healthcare spending and the prioritization of gastrointestinal disorders by both public and private healthcare players are driving the growth of the famotidine market, especially in the Asia-Pacific region[4].

Key Takeaways

• The famotidine market is expected to grow significantly, reaching USD 13.5 billion by 2031.
• The market is driven by the increasing prevalence of gastrointestinal disorders, preference for OTC remedies, and advancements in pharmaceutical formulations.
• The Asia-Pacific region is a key growth area due to modernizing healthcare systems and rising healthcare spending.
• Generic competition and the adoption of PPIs are significant challenges, but ongoing R&D and the emergence of generic alternatives present opportunities for growth.

FAQs

What is the projected market size of famotidine by 2031?

The famotidine market is expected to reach USD 13.5 billion by 2031, growing at a CAGR of 7.6% from 2024 to 2031[1].

What are the main drivers of the famotidine market?

The main drivers include the increasing prevalence of gastrointestinal disorders, preference for OTC remedies, advancements in pharmaceutical formulations, and the aging population[1][5].

Which region is expected to witness the highest growth in the famotidine market?

The Asia-Pacific region is expected to witness the highest growth due to modernizing healthcare systems, rising healthcare spending, and the presence of prominent generic drug manufacturers[1][4].

What challenges does the famotidine market face?

The market faces challenges from generic competition, the adoption of PPIs, and strict regulatory processes[4].

How is the shift away from PPIs affecting the famotidine market?

The shift away from PPIs due to their long-term risks is increasing the demand for famotidine, which is perceived to have a safer profile and lower risk of side effects[5].

Sources

1. Market Research Intellect: "Famotidine Market Size, Share and Trends [2024-2031]".
2. 2022 Annual Report: "2022-annual-report.pdf".
3. Managed Healthcare Executive: "Peptic Ulcer Disease Drug Pipeline: What You Need to Know".
4. Coherent Market Insights: "H2 Receptor Antagonist Market Size & Share Analysis - Growth Trends".
5. IMARC Group: "Famotidine (Pepcid) Manufacturing Plant Project Report 2024".