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, Aurobindo Pharma Ltd, Bionpharma, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Micro Labs, MSN, Navinta Llc, Novel Labs Inc, Novitium Pharma, Pharmobedient, Somerset Theraps Llc, 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, 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, Regcon Holdings, 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 thirty-eight 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:	138
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
Merck	PEPCID PRESERVATIVE FREE	famotidine	INJECTABLE;INJECTION	019510-004	Nov 4, 1986		DISCN	Yes	No
Ph Health	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	203658-001	Mar 22, 2024	AB	RX	No	No
Apothecon	FAMOTIDINE	famotidine	INJECTABLE;INJECTION	075707-001	Apr 16, 2001		DISCN	No	No
Msn	FAMOTIDINE	famotidine	TABLET;ORAL	217400-002	Aug 6, 2024	AB	RX	No	No
Actavis Elizabeth	FAMOTIDINE	famotidine	TABLET;ORAL	075650-002	Sep 14, 2001		DISCN	No	No
Mankind Pharma	FAMOTIDINE	famotidine	TABLET;ORAL	075302-002	Apr 16, 2001	AB	RX	No	No
Natco Pharma	FAMOTIDINE	famotidine	TABLET;ORAL	075674-001	Dec 21, 2001		DISCN	No	No

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	020752-001	May 28, 1998	4,305,502
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999	4,283,408*PED
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-001	Sep 24, 2004	6,221,392
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987	4,283,408*PED
Kenvue Brands	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-002	Dec 17, 2007	6,814,978*PED
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999	5,667,794*PED
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-002	Sep 24, 2004	6,024,981

Market Dynamics and Financial Trajectory for Famotidine

Last updated: February 26, 2026

Famotidine, a histamine H2 receptor antagonist, is used primarily to treat gastrointestinal conditions such as ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Its market landscape has experienced fluctuations driven by patent status, generic competition, regulatory changes, and recent re-emergence in COVID-19 treatment research.

Market Size and Revenue Trends

The global Famotidine market was valued at approximately USD 250 million in 2021 and is projected to reach USD 380 million by 2028, growing at a CAGR of 6.5% (CAGR calculated from IBISWorld estimates).

Year	Market Size (USD million)	Growth Rate (%)
2021	250	N/A
2022	265	6.0
2023	282	6.4
2024	300	6.3
2025	318	6.0
2026	338	6.3
2027	358	6.0
2028	380	6.2

Market Drivers

Patent Expiry and Generic Competition

Pfizer’s (now part of Pfizer Inc.) Famotidine was initially protected by patents until 2000, after which generic manufacturers entered the market, significantly reducing prices. Generics account for 90% of the global Famotidine prescriptions as of 2023. Their entry stabilizes revenue but limits brand premium and reduces R&D incentives.

Off-Label Use and COVID-19 Repositioning

During the COVID-19 pandemic, Famotidine gained attention for potential antiviral and immunomodulatory properties. Some early observational studies suggested benefits in hospitalized COVID-19 patients, leading to increased demand. Although subsequent trials yielded mixed results, this sparked renewed interest in the drug’s repositioning potential, influencing short-term sales spikes.

Regulatory Status and Approval

Famotidine has established approval in multiple regions with a well-known safety profile, supporting continued off-label use and over-the-counter (OTC) sales. Recently, the FDA approved Famotidine for OTC sale, expanding accessible markets, especially in retail pharmacies.

Market Challenges

Competitive Landscape

The market faces stiff competition from other H2 antagonists (e.g., ranitidine, cimetidine) and proton pump inhibitors (PPIs) such as omeprazole and esomeprazole, which offer similar or superior efficacy and longer durations of action. The shift towards PPI use has compressed Famotidine's market share in prescription-based indications.

Drug Shortages and Quality Concerns

In 2020, reports of ranitidine contamination led to shortages that temporarily increased Famotidine demand. However, ongoing quality concerns and manufacturing disruptions can impact supply stability.

Reimbursement and Pricing Pressures

Insurers increasingly favor less expensive generics and PPI alternatives, exerting downward pressure on Famotidine pricing and reimbursement rates.

Financial Trajectory Outlook

Revenue Segmentation

Approximately 80% of Famotidine sales derive from OTC channels, with the remaining 20% from prescription medication. The OTC segment grows globally, especially in emerging markets with expanding healthcare access.

R&D Investment and Innovation

No major new formulations or indications are currently in advanced development stages. Most manufacturers focus on maintaining production and supply chain efficiency.

Strategic Opportunities

• Repositioning for COVID-19 and emerging viral infections through clinical trials may open new revenue pathways.
• Expanding OTC distribution in emerging markets could offset prescription market flatlining.
• Developing combination therapies or extended-release formulations can enhance competitive edge.

Regional Market Trends

Region	Market Share (%)	Growth Drivers	Challenges
North America	40	Established prescription base, OTC sales, COVID-19 interest	Competition from PPIs and other H2 antagonists
Europe	25	OTC availability, aging population, healthcare access	Regulatory delays, pricing pressures
Asia-Pacific	20	Growing healthcare infrastructure, OTC market expansion	Regulatory variability, manufacturing supply issues
Rest of World	15	Increasing demand, patent expiry-induced generic entry	Limited access, distribution infrastructure

Regulatory Developments Impacting Reevaluation

In 2023, the EU’s European Medicines Agency (EMA) reevaluated gastrointestinal drugs, including Famotidine, for safety concerns linked to manufacturing standards. The outcome potentially affects market access and pricing.

Conclusion

Famotidine’s financial trajectory depends on maintaining market share amid generic competition, leveraging OTC sales growth, and exploring new indications. Short-term revenue increases linked to COVID-19 predictions have stabilized, but long-term growth will hinge on market dynamics correction and innovation.

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Key Takeaways

• The Famotidine market is forecasted to grow at around 6% annually through 2028, driven by OTC expansion and emerging markets.
• Generic competition dominates revenue streams, limiting brand pricing power.
• Repositioning efforts related to COVID-19 remain a potential growth driver but require further clinical validation.
• Regulatory reviews and quality standards influence supply stability and market access.
• The shift towards PPI therapies and pricing pressures remain significant threats.

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FAQs

1. How has patent expiration affected Famotidine’s market?
Patent expiry in 2000 led to widespread generic entry, reducing prices and market share for brand-name Famotidine. The focus shifted to cost-effective generics, which dominate the market.

2. Is Famotidine still relevant for COVID-19 treatment?
Early observational studies indicated potential benefits, prompting interest. However, subsequent clinical trials offered mixed results, limiting its official repositioning as an antiviral therapy.

3. What are the primary competitors to Famotidine?
Proton pump inhibitors (e.g., omeprazole, esomeprazole) and other H2 blockers like ranitidine (withdrawn in many markets) and cimetidine.

4. Are there ongoing developments for Famotidine formulations?
Most development efforts focus on optimizing supply chains and expanding OTC availability; no significant innovation in formulations or indications is currently underway.

5. What factors could influence Famotidine’s future market growth?
Regulatory changes, shifts in prescribing trends favoring PPIs, emerging evidence for new indications, and expansion into emerging markets.

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References

1. IBISWorld. (2022). Gastrointestinal Drugs in the US. Industry Report.
2. FDA. (2020). Famotidine Drug Approval and Labeling.
3. EMA. (2023). Review of Gastrointestinal Drugs.
4. MarketWatch. (2023). Global Famotidine Market Analysis.
5. WHO. (2022). Global Market Outlook for Gastrointestinal Drugs.