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 four branded drugs marketed by Horizon, Torrent, Endo Operations, Alkem Labs Ltd, Ascent Pharms Inc, and Teva Pharms Usa, and is included in six 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.

Eleven suppliers are listed for this compound.

Summary for FAMOTIDINE; IBUPROFEN

International Patents:	25
US Patents:	5
Tradenames:	4
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	11
Clinical Trials:	6
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
Duke University	Phase 4
Pediatric Rheumatology Collaborative Study Group	Phase 4
Horizon Pharma Ireland, Ltd., Dublin Ireland	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
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No			Y
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No			Y
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No			Y
Endo Operations	FAMOTIDINE; IBUPROFEN	famotidine; ibuprofen	TABLET;ORAL	203658-001	Mar 22, 2024	AB	RX	No	No
Ascent Pharms Inc	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	216814-001	Mar 15, 2023	AB	RX	No	No
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No			Y

International Patents for FAMOTIDINE; IBUPROFEN

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1919288	MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME)
Denmark	2043637
European Patent Office	2438919	Compositions contenant de l'ibuprofene et de la famotidine ainsi que des compositions contenant de 25 mg a 28 mg de la famotidine (Compositions comprising famotidine and ibuprofen as well as compositions comprising 25 mg to 28 mg famotidine)
Japan	2009543885
World Intellectual Property Organization (WIPO)	2007012019
Brazil	PI0714937	forma de dosagem unitÁria oral, e, uso de uma forma de dosagem unitÁria

FAMOTIDINE; IBUPROFEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Famotidine and Ibuprofen

Introduction to Famotidine and Ibuprofen

Famotidine and ibuprofen are two widely used medications that cater to different health needs. Famotidine is a histamine-2 (H2) blocker used primarily to treat gastrointestinal disorders, while ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief and to reduce inflammation.

Famotidine Market Dynamics

Market Size and Growth

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 CAGR of 7.6% from 2024 to 2031[1][4].

Key Drivers

• Medical Applications: Famotidine's broad range of medical uses, including treating heartburn, sour stomach, acid indigestion, duodenal ulcers, and gastroesophageal reflux disease (GERD), drives its demand[1][4].
• Technological Advancements: Ongoing research and development to enhance famotidine formulations and delivery systems contribute to the market's growth[1].
• Aging Population: The increasing age of the population, which is more prone to digestive problems, supports the steady expansion of the famotidine market[1][4].
• Self-Medication Trend: The trend toward self-medication and the accessibility of famotidine in various formulations also fuel market growth[1].

Regional Analysis

• North America: This region dominated the global famotidine market in terms of revenue share in 2020 and is expected to continue its dominance due to strong product demand and rising incidence of gastric cancer[4].
• Asia-Pacific: This region is expected to witness lucrative growth due to rising awareness about Helicobacter pylori infection and other gastrointestinal health issues[4].

Ibuprofen Market Dynamics

Market Size and Growth

The global ibuprofen market was valued at USD 1.43 billion in 2023 and is estimated to reach USD 1.76 billion by 2032, growing at a CAGR of 2.44% during the forecast period[2][3].

Key Drivers

• Chronic Diseases: The increasing prevalence of chronic diseases such as rheumatoid arthritis, osteoarthritis, headaches, and cardiovascular disease drives the demand for ibuprofen[2][3].
• Public Awareness and Urbanization: Growing public awareness of these diseases and rising urbanization contribute to the market's growth[2][3].
• Healthcare Spending: Increased healthcare spending and the trend toward self-medication for minor ailments also drive the demand for ibuprofen[2][3].

Price Trends

• Supply and Demand: The ibuprofen market has experienced upward pricing trends due to strong demand, supply chain disruptions, and higher production costs. Logistical challenges such as port congestion and higher freight charges have also contributed to price increases[5].
• Regional Variations: Prices have varied across regions, with North America seeing stable prices in Q2 2024 despite rising healthcare costs. Europe and Asia-Pacific have experienced fluctuations due to supply-demand imbalances and other market dynamics[5].

Financial Trajectory for Famotidine

Revenue Projections

The famotidine market is expected to more than double its revenue from USD 6.7 billion in 2023 to USD 13.5 billion by 2031, indicating a robust financial trajectory driven by increasing demand and technological advancements[1].

Investment Opportunities

• Research and Development: Companies investing in enhancing famotidine formulations and delivery systems are likely to see significant returns as these innovations drive market growth[1].
• Expanding Distribution Channels: Expanding distribution channels, especially in regions with growing awareness of gastrointestinal health, presents lucrative investment opportunities[4].

Financial Trajectory for Ibuprofen

Revenue Projections

The ibuprofen market is projected to grow from USD 1.43 billion in 2023 to USD 1.76 billion by 2032, with a moderate CAGR of 2.44%. This growth is driven by the increasing prevalence of chronic diseases and rising healthcare spending[2][3].

Cost and Pricing Dynamics

• Production Costs: Rising production costs and supply chain constraints are expected to keep upward pressure on ibuprofen prices, affecting the financial trajectory of the market[5].
• Market Adaptation: Pharmaceutical companies adapting their strategies to manage supply-demand dynamics and maintain market share will be crucial in navigating the financial landscape of the ibuprofen market[5].

Competitive Landscape

Famotidine

The famotidine market is characterized by strong competition among key players, with North America being a dominant region. Companies focusing on innovative formulations and expanding their distribution networks are likely to gain a competitive edge[4].

Ibuprofen

The ibuprofen market is also competitive, with several key players. The market is influenced by global demand, supply chain disruptions, and regional pricing trends. Companies that can manage these dynamics effectively will maintain their market share[2][3].

Challenges and Opportunities

Famotidine

• Challenges: The famotidine market faces challenges such as intense competition and the need for continuous innovation to stay ahead.
• Opportunities: Expanding into new regions, particularly in the Asia-Pacific where awareness of gastrointestinal health is rising, presents significant opportunities[4].

Ibuprofen

• Challenges: The ibuprofen market faces challenges such as supply chain disruptions, rising production costs, and regulatory pressures.
• Opportunities: Increasing public awareness of chronic diseases and the trend toward self-medication offer opportunities for growth and market expansion[2][3].

Key Takeaways

• Famotidine Market: Expected to grow significantly due to its wide range of medical applications, technological advancements, and an aging population.
• Ibuprofen Market: Projected to grow moderately driven by the increasing prevalence of chronic diseases and rising healthcare spending.
• Financial Trajectory: Both markets offer investment opportunities in research and development, distribution expansion, and strategic market adaptation.
• Regional Dynamics: North America dominates the famotidine market, while the ibuprofen market is influenced by global demand and supply chain dynamics.

FAQs

What are the primary drivers of the famotidine market?

The primary drivers of the famotidine market include its wide range of medical applications, technological advancements, an aging population, and the trend toward self-medication[1][4].

How is the ibuprofen market expected to grow?

The ibuprofen market is expected to grow at a CAGR of 2.44% from 2024 to 2032, driven by the increasing prevalence of chronic diseases and rising healthcare spending[2][3].

What are the key challenges facing the ibuprofen market?

The key challenges facing the ibuprofen market include supply chain disruptions, rising production costs, and regulatory pressures[5].

Which region dominates the famotidine market?

North America dominates the famotidine market in terms of revenue share and is expected to continue its dominance over the forecast period[4].

How do price trends affect the ibuprofen market?

Price trends in the ibuprofen market are influenced by supply-demand imbalances, supply chain disruptions, and rising production costs, leading to upward pressure on prices[5].

Sources

1. Market Research Intellect: Famotidine Market Size, Share and Trends [2024-2031][1].
2. Straits Research: Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report[2].
3. Verified Market Research: Ibuprofen Market Size, Share, Scope, Trends, Growth & Forecast[3].
4. Contrivedatum Insights: Famotidine Market - Global Industry Analysis, Size, Share, Growth Opportunities, Future Trends[4].
5. Procurement Resource: Ibuprofen Price Trend, Index, News, Chart, Database[5].