FAMOTIDINE; IBUPROFEN - Generic Drug Details

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

Famotidine; ibuprofen is the generic ingredient in two branded drugs marketed by Horizon, Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Ph Health, Teva Pharms Usa, Torrent, and Zydus Pharms, and is included in eight NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Famotidine; ibuprofen has twenty-five patent family members in fifteen countries.

Fifteen suppliers are listed for this compound.

Summary for FAMOTIDINE; IBUPROFEN

International Patents:	25
US Patents:	5
Tradenames:	2
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	15
Clinical Trials:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FAMOTIDINE; IBUPROFEN
DailyMed Link:	FAMOTIDINE; IBUPROFEN at DailyMed

Recent Clinical Trials for FAMOTIDINE; IBUPROFEN

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

Sponsor	Phase
Texas Scottish Rite Hospital for Children	PHASE2
Duke University	Phase 4
Pediatric Rheumatology Collaborative Study Group	Phase 4

See all FAMOTIDINE; IBUPROFEN clinical trials

Pharmacology for FAMOTIDINE; IBUPROFEN

Drug Class	Histamine-2 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for FAMOTIDINE; IBUPROFEN

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

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for FAMOTIDINE; IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DUEXIS	Tablets	famotidine; ibuprofen	800 mg/26.6 mg	022519	1	2011-12-06

US Patents and Regulatory Information for FAMOTIDINE; IBUPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	211278-001	Oct 29, 2021	AB	RX	No	No
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No	8,318,202		Y
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No	8,309,127		Y
Torrent	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	215925-001	Mar 18, 2024		DISCN	No	No
Zydus Pharms	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	218684-001	Feb 20, 2025	AB	RX	No	No

International Patents for FAMOTIDINE; IBUPROFEN

Country	Patent Number	Title	Estimated Expiration
Portugal	2043637
China	101257800
Australia	2007275360
European Patent Office	1919288	MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME)
Japan	2009543885

Market Dynamics and Financial Trajectory for the Pharmaceutical Drugs: Famotidine and Ibuprofen

Last updated: July 29, 2025

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Introduction

The pharmaceutical landscape for over-the-counter (OTC) and prescription medications is shaped by evolving market dynamics driven by clinical innovation, regulatory shifts, consumer demand, and geographic expansion. Among the most widely used drugs are famotidine, an H2 receptor antagonist primarily prescribed for acid-related gastrointestinal conditions, and ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) extensively used for pain, inflammation, and fever. Understanding their market trajectories requires analyzing historical trends, current challenges, emerging opportunities, regulatory influences, and competitive forces.

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Market Overview and Historical Context

Famotidine

Famotidine has historically served as a cornerstone for managing gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. It gained popularity in the 1980s after Food and Drug Administration (FDA) approval, competing against earlier agents like cimetidine.

The market experienced a significant shift in 2019 following reports linking certain ranitidine formulations to contamination with N-Nitrosodimethylamine (NDMA), prompting recalls and a surge in famotidine demand as a safer alternative. This event accentuated the drug’s importance in the GI therapy landscape and increased public and clinician reliance on famotidine options [1].

Ibuprofen

As a cornerstone NSAID, ibuprofen’s origins trace back to the 1960s. It became a household name for pain relief and anti-inflammatory treatment due to its efficacy, safety profile, and affordability. Over decades, ibuprofen's market expanded globally, aided by the broad OTC availability and continual product innovations, such as formulations with extended release or combined with other agents.

The advent of prescription-strength formulations and the emergence of combination therapies positioned ibuprofen as a core multinational drug with high brand and generics availability.

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Current Market Dynamics

Famotidine

• Market Resurgence and Demand Fluctuations: The NDMA contamination crisis that led to rappelerfamotidine marked a turning point. While initially disruptive, it catalyzed a resurgence of demand for proven safe alternatives in the H2 antagonists class [2].

• Biosimilars and Generics: Patent expirations in the early 2000s catalyzed the proliferation of generics, driving price competition and expanding access. Recent years have seen tightening margins but increased volumes.

• COVID-19 Dynamics: Some preliminary studies suggested famotidine's potential role in COVID-19 management, leading to a brief spike in interest and research funding. Though results remain inconclusive, these efforts could influence future demand and positioning within antiviral research landscapes [3].

• Regulatory and Patent Considerations: Currently, famotidine faces no significant patent barriers, facilitating competition but limiting premium pricing. Regulatory agencies have also mandated clearer safety data, influencing ongoing formulation updates.

Ibuprofen

• Market Penetration and Competition: The OTC market for ibuprofen remains highly competitive, with major pharmaceutical companies and numerous generics offering cost-effective alternatives. The global demand sustains stable growth in developed and developing markets.

• Innovations and Formulations: Extended-release formulations, combination products, and targeted dosing improve patient compliance and opening new therapeutic niches. For example, low-dose formulations targeting chronic pain management are gaining prominence.

• Regulatory Challenges: The NSAID class, including ibuprofen, faces heightened scrutiny regarding adverse effects like gastrointestinal bleeding and cardiovascular risks. These safety concerns influence prescribing patterns and consumer perceptions, prompting manufacturer investments in safer formulations [4].

• Impact of the COVID-19 Pandemic: Early controversy regarding NSAIDs and COVID-19 potentially affecting immune response created market hesitation; however, subsequent evidence diminished these fears, maintaining consumer and clinician trust.

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Emerging Trends and Opportunities

Famotidine

• Repurposing and Research: Ongoing clinical trials investigating famotidine's potential for COVID-19 treatment could establish new therapeutic niches, possibly restoring demand in antiviral indications.

• Formulation and Delivery Innovations: Enhanced delivery systems, such as extended-release tablets or novel delivery mechanisms, serve to improve patient compliance and therapeutic efficacy, potentially commanding premium pricing.

• Market Expansion: Emerging markets in Asia and Africa present growth opportunities due to increasing incidences of GI diseases and expanding healthcare infrastructure.

Ibuprofen

• Personalized Medicine: Advances in pharmacogenomics offer prospects for tailored NSAID therapy, reducing adverse effects and enhancing efficacy.

• Combination Therapies: Pairing ibuprofen with gastroprotective agents or other analgesics responds to safety concerns while broadening therapeutic applications.

• Sustainable Production: Environmental concerns prompt innovations in green manufacturing, reducing environmental footprint and aligning with eco-conscious consumer values.

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Regulatory and Competitive Forces

Both drugs operate in highly regulated environments, with continuous monitoring of safety profiles influencing market access and formulations. Patent expiration timelines and the rise of biosimilars further intensify competitive pressures, ushering in price competition and innovation in formulations.

Regulators are increasingly demanding real-world evidence of safety and efficacy, influencing R&D investments and market strategies. Digital health integration, such as pharmacovigilance platforms and telemedicine, reshapes how these medications are prescribed and monitored.

Financial Trajectory and Investment Outlook

Famotidine

In the near term, famotidine’s market growth hinges on research outcomes related to COVID-19 repurposing and the expansion of accessible formulations. The global gastrointestinal therapeutics market is projected to grow at a compounded annual growth rate (CAGR) of approximately 4.5% through 2028, with famotidine playing an integral role [5].

Ibuprofen

The global NSAID market, including ibuprofen, is expected to reach USD 9.4 billion by 2027, with a CAGR of 3.9%, driven by aging populations and increasing prevalence of chronic pain conditions. Innovations in safer formulations and combination therapies are anticipated to bolster growth [6].

Market Barriers and Risks

For both drugs, safety concerns, regulatory hurdles, and competitive pricing pressure remain critical risks. The potential for adverse event restrictions or new safety warnings could dampen market expansion.

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Conclusion

Famotidine and ibuprofen occupy pivotal spaces within the global pharmaceutical market, with distinct yet overlapping trajectories driven by safety profiles, regulatory landscapes, and technological innovations. While famotidine benefits from ongoing research and a resurgence in demand due to safety concerns over related drugs, ibuprofen's broad-spectrum utility sustains its steady growth amidst safety-related challenges. Both drugs' future success depends on proactive innovation, regulatory agility, and strategic market expansion.

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Key Takeaways

• Famotidine’s market growth is increasingly linked to safety perceptions, regulatory developments, and potential antiviral applications.
• Ibuprofen’s global demand remains resilient, driven by innovation, aging populations, and evolving formulation strategies.
• Competition from generics, biosimilars, and new formulations will shape pricing and market share.
• Regulatory scrutiny over safety profiles necessitates ongoing product innovation and pharmacovigilance.
• Emerging markets present significant growth opportunities for both drugs, contingent upon regulatory and healthcare infrastructure development.

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FAQs

1. How has the NDMA contamination crisis impacted famotidine's market?
   It led to recalls and a shift in consumer preference toward safer alternatives, boosting demand for verified safe formulations and generics, while also prompting regulatory agencies to reinforce safety standards [1].

2. What are the primary safety concerns associated with ibuprofen?
   Gastrointestinal bleeding, cardiovascular risks, and renal impairment are key safety issues. These concerns influence prescribing patterns and have led to the development of safer formulations and dosing strategies [4].

3. Are there ongoing clinical trials exploring famotidine’s use in COVID-19?
   Yes, multiple clinical trials are investigating famotidine’s potential for COVID-19 management, which could influence future demand if outcomes demonstrate efficacy [3].

4. How does patent expiration affect the ibuprofen market?
   Patent expirations facilitate widespread generics, leading to price competition but also prompting innovation in formulations. This dynamic sustains affordability and access but pressures profit margins [6].

5. What are the future opportunities for innovation in these drugs?
   In famotidine, advancements include novel delivery systems and repurposing for viral illnesses. For ibuprofen, opportunities lie in personalized dosing, combination therapies, and safer formulations to mitigate adverse effects.

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References

[1] Food and Drug Administration (FDA). (2019). Ranitidine drugs: Recall due to NDMA contamination.
[2] MarketWatch. (2021). Famotidine market analysis post-NDMA crisis.
[3] ClinicalTrials.gov. (2022). Studies on famotidine for COVID-19 treatment.
[4] European Medicines Agency (EMA). (2020). NSAID safety updates.
[5] Grand View Research. (2022). Gastrointestinal therapeutics market outlook.
[6] Fortune Business Insights. (2023). NSAID market analysis and forecasts.

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