FAMOTIDINE - Generic Drug Details

What are the generic drug sources for famotidine and what is the scope of freedom to operate?

Famotidine is the generic ingredient in fourteen branded drugs marketed by Ajanta Pharma Ltd, Akorn, Alkem Labs Ltd, Amneals Pharms, Annora Pharma, Carnegie, Epic Pharma Llc, Lupin Ltd, Micro Labs, Navinta Llc, Novel Labs Inc, Novitium Pharma, Unichem, Upsher Smith Labs, Salix Pharms, Apotex Inc, Apothecon, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent, Zydus Pharms, Abbvie, Baxter Hlthcare, Merck, Merck Sharp Dohme, Perrigo, J And J Consumer Inc, Ucb Inc, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Carlsbad, Chartwell Rx, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Graviti Pharms, Ivax Sub Teva Pharms, Mankind Pharma, Marksans Pharma, MSN, Mylan Pharms Inc, Natco Pharma, P And L, Perrigo R And D, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Bausch, Horizon, Torrent, Endo Operations, and Teva Pharms Usa, and is included in ninety-eight NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for famotidine. One hundred and forty-four suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for FAMOTIDINE

US Patents:	5
Tradenames:	14
Applicants:	62
NDAs:	98
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	144
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	118
Patent Applications:	7,350
Drug Prices:	Drug price trends for FAMOTIDINE
Drug Sales Revenues:	Drug sales revenues for FAMOTIDINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FAMOTIDINE
What excipients (inactive ingredients) are in FAMOTIDINE?	FAMOTIDINE excipients list
DailyMed Link:	FAMOTIDINE at DailyMed

See drug prices for FAMOTIDINE

See drug sales revenues for FAMOTIDINE

Recent Clinical Trials for FAMOTIDINE

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

Sponsor	Phase
University of Miami	Phase 3
Celgene	Phase 1
CURE Drug Repurposing Collaboratory (CDRC)	Phase 3

See all FAMOTIDINE clinical trials

Generic filers with tentative approvals for FAMOTIDINE

Applicant	Application No.	Strength	Dosage Form
		10MG/ML	Injectable; Injection
		10MG/ML	Injectable; Injection
		10MG/ML	Injectable; Injection

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for FAMOTIDINE

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

Medical Subject Heading (MeSH) Categories for FAMOTIDINE

Anti-Ulcer Agents

Histamine H2 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for FAMOTIDINE

A02BA	H2-receptor antagonists
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for FAMOTIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	FAMOTIDINE	famotidine	TABLET;ORAL	075062-001	Apr 16, 2001		DISCN	No	No
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987		DISCN	Yes	No
Endo Operations	FAMOTIDINE; IBUPROFEN	famotidine; ibuprofen	TABLET;ORAL	203658-001	Mar 22, 2024	AB	RX	No	No
Perrigo R And D	FAMOTIDINE	famotidine	TABLET;ORAL	077351-001	Sep 25, 2006		OTC	No	No
Mankind Pharma	FAMOTIDINE	famotidine	TABLET;ORAL	075302-001	Apr 16, 2001	AB	RX	No	No
Aurobindo Pharma Ltd	FAMOTIDINE	famotidine	TABLET;ORAL	206530-001	Dec 22, 2015	AB	RX	No	No

Expired US Patents for FAMOTIDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-002	Dec 17, 2007
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-001	May 28, 1998
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-002	Sep 24, 2004

FAMOTIDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Famotidine

Introduction to Famotidine

Famotidine, an H2 receptor antagonist, is widely used for treating various gastrointestinal disorders, including gastroesophageal reflux disease (GERD), peptic ulcer disease, Zollinger-Ellison syndrome, heartburn, and indigestion. The market for famotidine is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The famotidine market was valued at USD 6.7 billion in 2023 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 Incidence of Gastrointestinal Disorders

The rising incidence of GERD, ulcers, and other acid-related disorders is a major driver of the famotidine market. As the population ages and lifestyle choices contribute to higher rates of digestive diseases, the demand for effective treatments like famotidine increases[1][5].

Technological Advancements

Advancements in pharmaceutical formulations and delivery systems enhance the effectiveness and practicality of famotidine products. This includes the development of new formulations and the expansion of distribution channels, such as online pharmacies, which improve accessibility for patients[1][5].

Growing Awareness and Self-Medication

The trend toward self-medication and the growing awareness of gastrointestinal health are significant drivers. Patients are increasingly seeking over-the-counter remedies for acid-related ailments, and famotidine's availability in various formulations caters to this demand[1][5].

Affordability and Efficacy

Famotidine is known for its affordability and efficacy compared to other treatments. Its strong safety profile and broad approval for various conditions further fuel its market growth[5].

Market Segmentation

By Application

The market is segmented based on applications such as GERD, peptic ulcer disease, Zollinger-Ellison syndrome, heartburn, and indigestion. Each of these segments is experiencing growth due to the increasing prevalence of these conditions[1].

By Product

Famotidine is available in various forms, including tablets, injections, and oral suspensions. The demand for these products is driven by their ease of use and the specific needs of different patient groups[1].

By Geography

Geographically, the market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America, particularly the United States and Canada, is a significant player due to its robust economy and strong consumer base. The Asia-Pacific region is also experiencing rapid growth due to a large population, rising disposable income, and increasing urbanization[1][5].

Competitive Landscape

The famotidine market is competitive, with key players including Merck & Co., Johnson & Johnson, Teva Pharmaceuticals, Novartis, Mylan, Hikma Pharmaceuticals, Glenmark Pharmaceuticals, Lupin, Perrigo, and Sun Pharmaceutical. These companies are focusing on innovation, commercial strategies, and expanding their product portfolios to maintain market share[1].

Financial Performance and Investments

The pharmaceutical industry, which includes the famotidine market, has seen significant financial performance in recent years. For instance, major pharmaceutical companies have reported solid financial results, with operational sales growth and substantial investments in research and development. In 2022, one major pharmaceutical company invested nearly $15 billion in R&D and deployed over $17 billion towards acquisitions, indicating the industry's commitment to innovation and growth[2].

Challenges and Opportunities

Challenges

Despite the growth, the famotidine market faces challenges such as patent expirations, which can lead to the introduction of generic products and result in revenue and market share losses. Additionally, the market is subject to regulatory approvals, health plan coverage, and customer access, which can impact its growth[2].

Opportunities

The market presents several opportunities, including the potential for new indications and transformative regimens. Ongoing research and development initiatives to enhance famotidine formulations and delivery systems offer avenues for growth. The expanding global healthcare infrastructure and the increasing awareness of gastrointestinal health also present significant opportunities[1][3].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the famotidine market. While it presented challenges in terms of supply chain disruptions and changes in consumer behavior, it also accelerated the demand for over-the-counter medications as people sought to manage health issues at home. The market has adapted to these changes, and the long-term outlook remains positive[4].

Famotidine API Market

The Famotidine Active Pharmaceutical Ingredient (API) market is also experiencing significant growth. This market is segmented by type (purity ≥98%, purity <98%) and application (famotidine tablets, others). The API market is driven by the same factors as the overall famotidine market, including the increasing demand for effective treatments for gastrointestinal disorders and advancements in pharmaceutical formulations[3].

Regional Market Dynamics

North America

North America, particularly the United States and Canada, dominates the famotidine market due to strong product demand and a robust economy. The region's high purchasing power and well-established healthcare infrastructure support the market's growth[1][5].

Europe

Europe is another major region, characterized by a mature market with well-established infrastructure and consumer preferences. Countries such as the UK, Germany, France, and Italy contribute significantly to the European market[5].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth driven by countries like China, Japan, India, and South Korea. The large population, rising disposable income, and increasing urbanization in this region are key factors contributing to the market's expansion[1][5].

Key Takeaways

• The famotidine market is projected to grow significantly, driven by the increasing incidence of gastrointestinal disorders and advancements in pharmaceutical formulations.
• The market is segmented by application, product form, and geography, with North America and the Asia-Pacific region being key contributors.
• Major pharmaceutical companies are investing heavily in R&D and expanding their product portfolios to maintain market share.
• Despite challenges such as patent expirations, the market presents several opportunities for growth, including new indications and transformative regimens.

Frequently Asked Questions (FAQs)

Q: What is the projected growth rate of the famotidine market from 2024 to 2031? A: The famotidine market is expected to grow at a CAGR of 7.6% from 2024 to 2031[1].

Q: Which regions are the major contributors to the famotidine market? A: North America, particularly the United States and Canada, and the Asia-Pacific region are the major contributors to the famotidine market[1][5].

Q: What are the key drivers of the famotidine market growth? A: The key drivers include the increasing incidence of gastrointestinal disorders, technological advancements in pharmaceutical formulations, and growing awareness and self-medication trends[1][5].

Q: Which companies are the key players in the famotidine market? A: Key players include Merck & Co., Johnson & Johnson, Teva Pharmaceuticals, Novartis, Mylan, Hikma Pharmaceuticals, Glenmark Pharmaceuticals, Lupin, Perrigo, and Sun Pharmaceutical[1].

Q: How has the COVID-19 pandemic impacted the famotidine market? A: The COVID-19 pandemic has had a mixed impact, presenting challenges but also accelerating the demand for over-the-counter medications as people sought to manage health issues at home[4].

Cited Sources:

1. Market Research Intellect, "Famotidine Market Size, Share and Trends [2024-2031]".
2. 2022 Annual Report, Johnson & Johnson.
3. Market Research Intellect, "Global Famotidine API Market Size, Scope And Forecast Report".
4. Contrive Datum Insights, "Famotidine Market - Global Industry Analysis, Size, Share, Growth Opportunities, Future Trends, Covid-19 Impact, SWOT Analysis, Competition and Forecasts 2023 to 2030".
5. OpenPR, "Famotidine Tablets Market Size, Share and Forecast By Key".