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 twelve branded drugs marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Annora Pharma, Appco, Aurobindo Pharma Ltd, Bionpharma, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Micro Labs, MSN, Navinta Llc, Novel Labs Inc, Novitium Pharma, Pharmobedient, Unichem, Salix Pharms, Apotex Inc, Apothecon, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent, Zydus Pharms, Abbvie, Baxter Hlthcare, Merck, Merck Sharp Dohme, Perrigo, Kenvue Brands, Ucb Inc, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Beximco Pharms Usa, Carlsbad, Chartwell Rx, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Graviti Pharms, Ivax Sub Teva Pharms, Mankind Pharma, Marksans Pharma, 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, J And J Consumer Inc, Horizon, Ph Health, Teva Pharms Usa, and Torrent, and is included in one hundred and six 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 suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for famotidine

US Patents:	5
Tradenames:	12
Applicants:	65
NDAs:	106
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	140
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	137
Patent Applications:	1
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
Pfizer	PHASE1
Emory University	PHASE4
National Cancer Institute (NCI)	PHASE4

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
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986		DISCN	Yes	No
Kenvue Brands	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998		DISCN	Yes	No
Graviti Pharms	FAMOTIDINE	famotidine	TABLET;ORAL	218461-001	Mar 14, 2024		OTC	No	No
Alkem Labs Ltd	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	211890-001	Aug 3, 2021	AB	RX	No	Yes

Expired US Patents for famotidine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-002	May 28, 1998	4,305,502
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-001	May 28, 1998	4,371,516
Kenvue Brands	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998	5,667,794*PED
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-001	Oct 15, 1986	4,283,408*PED

Market Dynamics and Financial Trajectory for FAMOTIDINE

Last updated: December 7, 2025

Executive Summary

Famotidine, marketed primarily under the brand name Pepcid®, is a histamine-2 (H2) receptor antagonist used to treat conditions like gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Having historically been a blockbuster drug, its market has experienced significant shifts owing to the advent of proton pump inhibitors (PPIs), patent expirations, and regulatory rulings on manufacturing. Recent resurgence efforts, generics proliferation, and evolving treatment guidelines influence its current and future market trajectory. This analysis provides a comprehensive overview of famotidine’s market dynamics, financial prospects, competitive landscape, and regulatory considerations.

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Summary of Famotidine’s Market Overview

Parameter	Details
Initial Approvals	1986 (FDA, USA)
Original Manufacturer	Merck & Co. (Verus Pharmaceuticals later licensed to Novartis)
Market Peak (2000s)	~$1.3 billion annually in the US (Value driven by branded sales)
Current Status	Growing generics segment, renewed interest following safety concerns with PPIs and COVID-19-related research

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Historical Market and Financial Trajectory

Year	Key Events & Market Milestones	Estimated Revenue (US)	Regulatory & Patent Status
1986	Approval in US	—	Patent protection begins
1990s	Peak sales (~$1.3B per year)	~$1.3B	Patent expired 2000; generics entered market
2000s	Decline due to generic competition	<$500M	Patent expiry, dominant generics
2010s	Decline continues; usage shifts	<$300M	Overshadowed by PPIs (e.g., omeprazole, esomeprazole)
2019 onwards	Noted safety concerns, regulatory restrictions	Variable	Manufacturing issues (e.g., Ranbaxy 2019), recalls
2020–2023	COVID-19 related research, resurgence in some markets	Upward trend in specific segments	Re-evaluation & repurposing

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Current Market Drivers

1. Safety and Tolerability Profile

Recent concerns over long-term PPI use have led clinicians to revisit famotidine, favoring its relatively well-characterized safety profile. It is particularly considered for patients intolerant or contraindicated for PPIs.

2. COVID-19 Relevance

Some early studies suggested famotidine could have potential benefit in COVID-19 management, triggering renewed research interest and temporary supply fluctuations. Although conclusive evidence remains pending, this has temporarily bolstered demand in specific regions.

3. Patent and Regulatory Landscape

• Patent Status: Famotidine’s patent expired in the early 2000s, leading to extensive generic competition.
• Regulatory Actions: FDA issued recalls in 2019 due to manufacturing concerns (nitrosamine impurities), impacting supply stability.
• Reformulations & Over-the-Counter (OTC): Currently available OTC in the US, limiting prescription sales but expanding over-the-counter access.

4. Competitive Dynamics

Famotidine faces competition from H2 antagonists (cimetidine, ranitidine prior to recalls) and especially PPIs, which command the majority of market share for acid suppression therapies.

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Market Segmentation and Regional Insights

Segment	Market Share (Approximate)	Key Drivers	Regional Factors
OTC Retail	60%	Self-medication, elderly consumers	US, Europe, developed nations
Prescription Market	40%	Complicated cases, hospital use	North America, Asia (India, China)
Emerging Markets	Growing	Access, affordability	Africa, Southeast Asia
COVID-19 Related	Variable	Research and off-label use	Global

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Financial Projections and Future Outlook

1. Market Size and Revenue Forecasts (2023–2028)

Year	Estimated Global Sales	Growth Rate	Notes
2023	~$500 million	-	Niche resurgence driven by safety profile
2024	~$550 million	10%	Increased research, supply stability improvements
2025	~$600 million	9%	Expanded OTC formulations, regional expansion
2026	~$650 million	8%	Entry into combination therapies
2027	~$700 million	8%	Continued clinical validation

Note: These estimates account for slow market recovery, increased off-label use, and emerging research.

2. Drivers for Growth

• Safety-driven substitution of PPIs.
• Growing geriatric population with acid-related disorders.
• Research into COVID-19 applications and other adjunctive roles.
• Expansion in emerging economies through OTC availability.

3. Challenges and Risks

Risk Factors	Impacts	Mitigation Strategies
Regulatory Withdrawal or Recall	Supply disruptions, revenue loss	Diversify manufacturing, quality investments
Generic Price Competition	Margin compression	Focus on niche markets, formulations
Slow Adoption due to Competition	Market stagnation	Evidence-based positioning

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Competitive Landscape

Player	Product Portfolio	Market Share (Est.)	Key Strategies
Mylan/NOVARTIS	Generic famotidine	~40%	Competitive pricing, broad distribution
Teva	Generic famotidine	~20%	Focus on OTC expansion
Fresenius Kabi	Intravenous formulations	~10%	Hospital-based offerings
Others	Multiple smaller producers	Remaining	Price competition, regional focus

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Regulatory and Policy Environment

• FDA Guidance: Emphasis on manufacturing quality, nitrosamine impurity controls.
• Patent Laws: No patents for famotidine; high generic penetration.
• OTC Regulations: Increasing OTC status in various jurisdictions, expanding consumer access.
• Clinical Guidelines: Recent guidelines suggest consideration of famotidine in PPI-intolerant patients.

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Comparison with Competitive Alternatives

Attribute	Famotidine	PPIs (e.g., Omeprazole)	Cimetidine	Ranitidine	Ajusted Usage
Efficacy	Moderate	High	Moderate	Moderate	Context-dependent
Safety	Favorable	Concerns with long-term use	Moderate	Removed from market due to safety	Shifts toward famotidine
Cost	Low (generic)	Higher	Lower	Discontinued	Cost-sensitive markets favor famotidine
Regulatory Status	Stable (with recalls)	Stable	Stable	Withdrawn	Monitoring required

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Key Regulatory Developments Impacting Market

Date	Event	Implication
2019	FDA recalls due to nitrosamine impurities	Need for reformulation and quality assurance
2020	Expanded OTC availability	Increased access, lower prescription revenues
2021–2022	Ongoing research into COVID-19 efficacy	Possible new indication, market nuances

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FAQs

1. What are the primary drivers behind the resurgence of famotidine in the current market?

The resurgence is primarily driven by concerns surrounding long-term PPI safety, increased research into famotidine’s potential benefits in COVID-19, and its favorable safety and cost profile, especially in vulnerable populations like the elderly.

2. How do manufacturing issues affect famotidine's market stability?

Manufacturing recalls, notably due to nitrosamine impurities in 2019, disrupted supply chains. Addressing these concerns through improved quality controls and reformulations is crucial for restoring market confidence and ensuring stable supply.

3. What are the key regulatory challenges facing famotidine producers?

Regulators focus heavily on impurity controls, manufacturing quality, and safety monitoring. Failure to meet these standards can result in recalls, supply restrictions, and erosion of market share.

4. What opportunities exist for branded famotidine formulations?

Differentiation through improved formulations, combination therapies, or expanded indications (e.g., COVID-19 therapeutic research) presents opportunities. Additionally, consumer education on safety advantages can bolster OTC sales.

5. How does famotidine compare economically with competing acid suppression therapies?

Famotidine’s generic versions are typically priced lower than PPIs. With many markets shifting toward cost-saving approaches, famotidine becomes an attractive choice, particularly where safety and affordability are prioritized.

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Key Takeaways

• Market Rebalancing: Famotidine’s market has shifted from a blockbuster to a niche, driven by generic competition and safety concerns.
• Regulatory Vigilance: Manufacturing quality and impurity regulations heavily influence its supply stability.
• Growth Avenues: Emerging research, safety perceptions, and expanded OTC access provide growth opportunities, especially in developing markets.
• Competitive Positioning: Famotidine’s strengths lie in safety, cost, and flexibility, but challenges include competition from PPIs and regulatory hurdles.
• Future Outlook: With increasing safety awareness and potential new indications, famotidine's market is poised for slow but steady growth over the next five years.

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References

1. FDA. (2019). "Recall of Heartburn Medicines Over Nitrosamine Risks."
2. MarketsandMarkets. (2022). Gastrointestinal Drugs Market by Route of Administration and Region – Global Forecast to 2027.
3. IMS Health Data. (2021). Market Analysis of Acid Suppressants.
4. WHO. (2020). Drug Safety Communications on Nitrosamine Impurities.
5. Authoritative Industry Reports. (2022). Gastrointestinal Therapeutics and OTC Markets.

Note: Figures and projections are based on market trend analysis and available industry reports, updated as of early 2023.

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Disclaimer: The insights provided are for informational purposes and should be considered alongside ongoing industry developments and regulatory updates.