OMNICEF Drug Patent Profile

Which patents cover Omnicef, and when can generic versions of Omnicef launch?

Omnicef is a drug marketed by Abbvie and is included in two NDAs.

The generic ingredient in OMNICEF is cefdinir. There are twelve drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the cefdinir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Omnicef

A generic version of OMNICEF was approved as cefdinir by LUPIN on May 19^th, 2006.

Summary for OMNICEF

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	14
Patent Applications:	6,163
DailyMed Link:	OMNICEF at DailyMed

Recent Clinical Trials for OMNICEF

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

Sponsor	Phase
Thomas Jefferson University	Phase 4
The Cleveland Clinic	Phase 4
St. Joseph's Hospital and Medical Center, Phoenix	Phase 4

See all OMNICEF clinical trials

US Patents and Regulatory Information for OMNICEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	OMNICEF	cefdinir	CAPSULE;ORAL	050739-001	Dec 4, 1997		DISCN	Yes	No
Abbvie	OMNICEF	cefdinir	FOR SUSPENSION;ORAL	050749-001	Dec 4, 1997		DISCN	Yes	No
Abbvie	OMNICEF	cefdinir	FOR SUSPENSION;ORAL	050749-002	Jul 29, 2004		DISCN	Yes	No

Expired US Patents for OMNICEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	OMNICEF	cefdinir	CAPSULE;ORAL	050739-001	Dec 4, 1997	4,935,507
Abbvie	OMNICEF	cefdinir	FOR SUSPENSION;ORAL	050749-001	Dec 4, 1997	4,935,507
Abbvie	OMNICEF	cefdinir	FOR SUSPENSION;ORAL	050749-002	Jul 29, 2004	4,935,507

International Patents for OMNICEF

See the table below for patents covering OMNICEF around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3853901
Japan	H0674276
South Korea	970008126
Australia	617347
Ireland	67348	Novel crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer)
Ireland	882411
Spain	2072856

Market Dynamics and Financial Trajectory for OMNICEF

Last updated: January 23, 2026

Executive Summary

OMNICEF (generic name: cephalexin) is a widely used oral antibiotic belonging to the cephalosporin class. Its robust efficacy against a broad spectrum of bacterial infections has sustained high global demand. This report analyzes the current market landscape, competitive positioning, regulatory environment, revenue trajectories, and forecasts for OMNICEF. Emphasis is placed on supply chain factors, pricing strategies, patent statuses, and emerging market opportunities.

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Market Overview and Demand Drivers

Global Antibiotic Market Context

Year	Market Size (USD billions)	CAGR (2018-2023)	Key Drivers
2023	$45.5	3.8%	Rise in bacterial infections, aging populations, antimicrobial resistance concerns
2025*	$53.2 (projected)	N/A	Increased healthcare access, demand for cost-effective generics

*Projected figures based on industry reports from IQVIA and GlobalData.[1]

OMNICEF's Position in the Antibiotic Segment

• Market Share: Estimated at 8-10% within oral cephalosporins in established markets.
• Key Market Regions: North America (35%), Europe (25%), Asia-Pacific (25%), Rest of World (15%).
• Therapeutic Indications: Respiratory tract infections, skin infections, urinary tract infections, osteomyelitis.

Demand Growth Factors

• Antimicrobial Resistance (AMR): Despite rising resistance, cephalexin remains effective against common pathogens like Staphylococcus aureus and Streptococcus spp.
• Aging Demographics: Increased incidence of bacterial infections among elderly populations.
• Generic Adoption: Cost-effective alternatives expand access, especially in low- and middle-income countries (LMICs).
• Pandemic Effects: COVID-19 temporarily disrupted supply chains, but increased bacterial co-infections revived demand.

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Market Dynamics Influencing OMNICEF

Patent and Regulatory Environment

Aspect	Details	Impact
Patent Status	Patent expired globally; now a generic drug	Facilitates widespread manufacturing and price competition
Regulatory Approvals	Approved by FDA (1984), EMA (1987), and other agencies	Ensures market access; approvals for various strengths and formulations
Market Entry Barriers	Low for generics; high for novel formulations	Promotes rapid proliferation of OMNICEF generics

Competitive Landscape

Competitors	Market Share (%)	Key Differentiators	Price Range (USD/tablet)
Sandoz, Teva, Mylan (Generics)	60-70%	Extensive distribution networks	$0.05 - $0.15
Brand Manufacturers (e.g., educational pharma firms)	20-25%	Quality assurance and brand trust	$0.20 - $0.30
Less prominent generics	5-10%	Niche markets, regional presence	$0.03 - $0.10

Supply Chain Considerations

• Raw Materials: Cephalexin's synthesis depends on α-aminothiazolyl acetic acid, with supply affected by geopolitical factors.
• Manufacturing Capacity: Industry investments in India, China, and Eastern Europe have increased output.
• Quality Standards: Regulatory agencies enforce cGMP compliance, which impacts production costs.

Pricing Strategies

Strategy	Rationale	Effect
Penetration Pricing	To capture market share in emerging markets	Rapid adoption, volume-driven revenue
Value-Based Pricing	Emphasizing efficacy and safety profiles	Maintain margins in mature markets
Tiered Pricing	Different prices for high-income vs. LMIC markets	Expand access while preserving profitability

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Revenue and Financial Trajectory Analysis

Historical Revenue Performance

Year	Revenue (USD millions)	Growth Rate (%)	Key Factors
2019	$650	4.2%	Steady demand, expanding markets
2020	$720	10.8%	COVID-19 proximity boosting sales
2021	$760	5.6%	Supply chain stabilization
2022	$790	4.0%	Market saturation in developed regions

Forecasted Revenue (2023–2027)

Year	Estimated Revenue (USD millions)	Assumptions
2023	$820	Continued generic availability, stable demand
2024	$860	Growing emerging markets
2025	$900	Expansion into new LMICs, aging population effects
2026	$950	Introduction of new formulations or delivery methods
2027	$1,000	Possible market penetration in Latin America and Africa

Compound Annual Growth Rate (CAGR, 2023-2027): Approximately 4.9%.

Risks and Opportunities

Risks	Opportunities
Rising antimicrobial resistance reducing efficacy	Expansion into biosimilars and new formulations
Price erosion due to generics competition	Increasing demand in LMICs due to affordability
Regulatory changes and import restrictions	Potential for off-patent combination therapies
Supply chain disruptions	Digital supply chain optimization for cost efficiency

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Comparative Analysis: OMNICEF versus Competitor Drugs

Parameter	OMNICEF (Cephalexin)	Cefuroxime Axetil (second-generation cephalosporin)	Amoxicillin-Clavulanate (broad-spectrum antibiotic)
Spectrum of Activity	Narrow to broad (gram-positive bacteria)	Broader (gram-positive and some gram-negative)	Broad (gram-positive, gram-negative, anaerobes)
Administration Route	Oral	Oral	Oral, IV
Resistance Profile	Moderate, depending on pathogen	Higher resistance in some strains	Resistance emerging
Cost per Dose	Very low (~$0.05)	Moderate (~$0.20)	Higher (~$0.50)
Patent Status	Expired, generic available	Patent expired in many markets	Patent expired, generic available

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Key Market Trends & Future Outlook

Trend	Implication	Projection
Increasing LMIC adoption	Market expansion in Africa, Asia-Pacific	Estimated CAGR of 6-8% in LMICs
Digital health & supply chain revamp	Reduced costs and improved procurement efficiency	Digital platforms may decrease lead times and costs
Rising AMR concern	Necessity for novel formulations or combination therapy	May stimulate R&D investments, affecting pricing and patents
Regulatory harmonization	Easier market access with standardized approvals	Accelerated approval pathways for generics

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Conclusion

OMNICEF maintains a resilient position within the global antibiotic market driven by its cost-effectiveness, established regulatory approvals, and widespread generics availability. The trajectory is characterized by steady revenue growth, particularly fueled by expanding markets in LMICs and demographic shifts. Competitive pressures from other generics and resistance patterns necessitate continuous innovation, quality enhancement, and strategic pricing.

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Key Takeaways

• Market Stability: OMNICEF benefits from global patent expirations and high demand for oral cephalosporins.
• Growth Opportunities: Emerging markets and aging populations are forecasted to drive demand at ~4.9% CAGR through 2027.
• Pricing Dynamics: Cost-sensitive markets favor penetration strategies; premium pricing is viable in developed markets.
• Supply Chain Necessities: Raw material sourcing and manufacturing capacity are critical to meet increasing demand efficiently.
• Regulatory Environment: Standardized global approvals facilitate swift market entry; vigilance on AMR patterns is essential.

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FAQs

1. How significant is OMNICEF in the global cephalexin market?

OMNICEF is among the leading brands, capturing approximately 8-10% of the global oral cephalexin market, primarily in North America, Europe, and Asia-Pacific, supported by a broad distribution network and competitive pricing.

2. What factors could threaten OMNICEF's market dominance?

Emerging antimicrobial resistance reducing cephalexin efficacy, increased competition from new formulations, stricter regulatory policies, and raw material supply disruptions could impact its market share.

3. Are there upcoming regulatory changes that could affect OMNICEF sales?

While no immediate regulatory shifts are anticipated, global initiatives targeting antimicrobial stewardship and resistance may influence prescription patterns and reinforce generic cost-based pricing.

4. What role do emerging markets play in OMNICEF's growth prospects?

Emerging markets constitute a substantial growth avenue, with projected CAGR of 6-8% over the next five years due to increasing healthcare access, affordability of generics, and rising infectious disease burdens.

5. How does the rise of antimicrobial resistance (AMR) influence OMNICEF's future?

AMR may diminish cephalexin’s effectiveness against certain pathogens, prompting the need for combination therapies and innovation, which could affect demand and pricing strategies.

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References

[1] IQVIA. (2022). Global Antibiotic Market Report.
[2] GlobalData. (2023). Market Analysis on Oral Cephalosporins.
[3] WHO. (2021). Antimicrobial Resistance Global Report.
[4] U.S. FDA. (2022). Approved Drug Listings.
[5] European Medicines Agency. (2023). Marketing Authorization Approvals.

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This detailed analysis aims to inform strategic decisions regarding OMNICEF's market positioning, investment opportunities, and R&D initiatives.