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.

Sixteen 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:	16
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
Aurobindo Pharma Ltd	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	219538-001	Jun 30, 2025		DISCN	No	No
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No			Y
Ph Health	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	203658-001	Mar 22, 2024	AB	RX	No	No
Teva Pharms Usa	IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	211278-001	Oct 29, 2021		DISCN	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	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)
European Patent Office	2043637	PROCÉDÉS ET MÉDICAMENTS DESTINÉS À L'ADMINISTRATION D'IBUPROFÈNE (METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN)
World Intellectual Property Organization (WIPO)	2007012022
Canada	2657928
Austria	E539747

FAMOTIDINE; IBUPROFEN Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for Famotidine and Ibuprofen?

Famotidine and ibuprofen operate within distinct segments of the pharmaceutical market, driven by differing therapeutic areas, patent statuses, and competitive landscapes.

Famotidine Market Overview

Famotidine, a histamine-2 (H2) receptor antagonist, treats gastroesophageal reflux disease (GERD) and peptic ulcers. Once dominant, its market has shifted following patent expirations and the emergence of proton pump inhibitors (PPIs).

• Market Size (2022): Estimated at $1.2 billion globally [1].
• Key Players: Multiple generics manufacturers with low barriers post-patent expiry.
• Market Trends: Declining demand due to the dominance of PPIs like omeprazole, which offer better efficacy.
• Regulatory Environment: Several formulations are off-patent, leading to increased generic competition.
• Supply Chain: Matures with established manufacturing networks; supply disruptions rare but possible due to ingredient sourcing issues.

Ibuprofen Market Overview

Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), is widely used for pain, inflammation, and fever.

• Market Size (2022): Estimated at over $8 billion globally [2].
• Key Players: Several multinational manufacturers, including Johnson & Johnson, Meda, and Teva.
• Market Trends: Steady growth driven by over-the-counter (OTC) demand; increasing use in low- and middle-income countries.
• Patent Status: Patents have long expired; market is dominated by generics.
• Regulatory Environment: Over-the-counter availability in many markets simplifies access; some countries impose regulations on dosage and packaging to mitigate safety risks.
• Supply Chain: High capacity with multiple manufacturing hubs; raw material sourcing is diversified.

Competitive Factors Impacting Market Dynamics

• Patent Expirations: Reduced barriers for generics have led to price erosion.
• Product Innovation: Limited scope for innovation in these established drugs; formulation enhancements focus near-term on improving bioavailability or reducing side effects.
• Pricing Pressures: Increased competition in both drugs has driven prices down, especially in OTC sectors.
• Healthcare Policies: Emphasis on cost-effectiveness influences prescribing patterns, favoring generics.
• Regulatory Approvals: Ease of approval for generics accelerates market entry and fosters saturation.

What Is the Financial Trajectory for These Drugs?

Famotidine

• Revenue Trend: Sharp decline from a peak of $1.4 billion in 2013, post-patent expiry [1].
• Current Revenue Sources: Generic sales dominate, with limited branded sales.
• Profitability: Margins compressed due to intense competition, with typical generic margins around 10–15%.
• Future Outlook: Market expected to decline further as PPIs maintain dominance; minimal new formulation development planned.

Ibuprofen

• Revenue Trend: Demonstrates consistent growth; OTC sales benefit from broad consumer access.
• Revenue Share: Dominated by generics with single-digit profit margins; top-selling brands contribute significant volumes.
• Profitability: Approximately 8–12% margins; high-volume generic production sustains profitability.
• Future Outlook: Sustained growth expected, especially in emerging markets. New formulations or combination products may stimulate incremental revenue.

Factors Influencing Financial Trajectories

• Patent statuses and regulatory changes impact pricing and market share.
• Generic competition limits pricing power.
• Consumer demand remains a primary driver; OTC accessibility influences sales volume.
• Price erosion and saturation levels pose long-term challenges.

How Do External Factors Affect Market and Financial Dynamics?

Regulatory Policies

• Stricter regulations on manufacturing quality and labeling can raise costs.
• Policies promoting generic substitution can increase sales volumes but suppress prices.
• Approvals for new formulations are rare for these drugs but could alter the competitive landscape if introduced.

Healthcare Insurance & Reimbursement

• Reimbursement policies favor low-cost generics for both drugs.
• Insurance coverage impacts consumer purchasing decisions, especially in OTC contexts.

Global Market Variability

• Developing countries exhibit growing demand due to increased disease prevalence and access.
• Competition from local manufacturers can create price pressures.
• Supply chain electrification is necessary to meet the rising demand sustainably.

Market Risks

• Potential shift towards alternative therapies could reduce demand.
• Supply disruptions or ingredient shortages may temporarily impact production.

Key Takeaways

• Famotidine's market has contracted due to generics and competition from PPIs; revenues declined significantly since patent expiry.
• Ibuprofen remains a high-volume OTC drug with steady growth. Generic competition limits margins but sustains profitability.
• External influences, including regulations and healthcare policies, shape future market and financial trajectories.
• Ongoing demand in emerging markets supports growth potential for ibuprofen; famotidine faces obsolescence risk unless repositioned.

FAQs

1. What are the main drivers for the decline of famotidine?

Patent expiration in 2008 and competition from more effective PPIs led to market share erosion. The shift in prescribing practices toward PPIs reduced demand for famotidine.

2. How sustainable is the growth of ibuprofen in the OTC segment?

High consumer demand and global accessibility make ibuprofen's OTC market sustainable. Growth may slow in mature markets but remains positive due to expanding health awareness and access in emerging countries.

3. Are there significant opportunities for innovation in these drugs?

Limited. Formulation improvements are incremental; major innovations would likely involve combination therapies or delivery methods rather than core molecules.

4. How do regulatory changes influence market competition?

Reduced barriers and approvals for generics facilitate market entry, intensifying competition and pressuring prices.

5. Will these drugs regain market share or revenues in the future?

Unlikely for famotidine unless repositioned or reformulated. Ibuprofen's demand outlook remains stable, with incremental growth driven by expanding markets and potential new formulations.

References

[1] IQVIA, "Global Medicine Sales Data," 2022.

[2] Statista, "Ibuprofen Market Revenue," 2022.