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-seven 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
The Cleveland Clinic	Phase 4
St. Joseph's Hospital and Medical Center, Phoenix	Phase 4
Thomas Jefferson University	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
Abbvie	OMNICEF	cefdinir	FOR SUSPENSION;ORAL	050749-002	Jul 29, 2004
Abbvie	OMNICEF	cefdinir	FOR SUSPENSION;ORAL	050749-001	Dec 4, 1997

International Patents for OMNICEF

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

Country	Patent Number	Title	Estimated Expiration
Japan	H01250384	NOVEL CRYSTAL OF 7-(2-(2-AMINOTHIAZOL-4-YL)-2-HYDROXYIMINOACETAMIDO)-3-VINYL-3-CEPHEM-4-CARBOXYLIC ACID (SYN ISOMER)
South Korea	970008126
Ireland	67348	Novel crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer)

Market Dynamics and Financial Trajectory for OMNICEF

Last updated: July 27, 2025

Introduction

OMNICEF, a widely utilized broad-spectrum antibiotic primarily containing cephalexin, holds a significant position in the bacterial infection treatment landscape. The drug’s market trajectory is influenced by evolving healthcare needs, antibiotic resistance trends, regulatory shifts, and competitive dynamics. This analysis dissects the current market environment and projects the financial outlook for OMNICEF over the next five years.

Market Overview

Global Pharmaceutical Market Context

The global antibiotic market was valued at approximately USD 48 billion in 2022, with an anticipated compound annual growth rate (CAGR) of around 3.5% through 2028 [1]. While the market faces challenges related to antimicrobial resistance (AMR) and regulatory scrutiny, demand persists driven by rising infection prevalence, aging populations, and expanding healthcare infrastructure, especially in emerging economies.

OMNICEF’s Position and Indications

OMNICEF (cephalexin) is indicated for respiratory tract infections, skin and soft tissue infections, otitis media, and urinary tract infections. Its established efficacy, oral bioavailability, and affordability consolidate its status in outpatient settings. The drug's patents typically expired in many jurisdictions, making it vulnerable to generic competition, which significantly impacts pricing and revenue.

Market Drivers

Growing Incidence of Bacterial Infections

An uptick in bacterial infections, especially in aging populations and immunocompromised patients, sustains demand for broad-spectrum antibiotics. According to WHO data, antibiotic use increased globally by an average of 14% over the past decade, underpinning a steady need for drugs like OMNICEF [2].

Antibiotic Prescribing Trends and Stewardship

While antibiotic stewardship programs aim to curtail overuse, the necessity for effective oral antibiotics like OMNICEF remains high. Its role as a first-line therapy in uncomplicated infections bolsters continued demand.

Expanding Markets in Emerging Economies

Countries such as India, China, and Brazil are witnessing rapid healthcare infrastructure expansion and increased antibiotic consumption. The burgeoning middle class and improved access to healthcare services propel the market for generic cephalexin formulations, positively influencing OMNICEF's sales.

Regulatory Environment and Patent Expiry

The expiration of patents in key markets catalyzes generic manufacturing, intensifying price competition. While generics reduce consumer costs, it compresses profit margins for original manufacturers, shifting focus to volume-based sales.

Market Challenges

Antimicrobial Resistance (AMR)

AMR remains the most significant threat to OMNICEF’s future. The development of beta-lactamase producing bacteria diminishes cephalexin’s efficacy, prompting regulatory agencies to tighten approval standards and discourage inappropriate use.

Regulatory Scrutiny and Restricted Use

Governments are implementing stricter guidelines to prevent overprescription of antibiotics. Such measures can constrain sales volumes and shift prescribing patterns toward newer, more targeted agents.

Competition from Advanced Antibiotics

Emerging antibiotics with broader spectra or improved safety profiles, such as ceftaroline or linezolid, provide clinicians with alternatives, especially in resistant infections, challenging OMNCEF’s market share.

Financial Trajectory Projection (2023-2028)

Revenue Trends

In mature markets, post-patent expiry, OMNICEF’s revenue is expected to plateau or decline marginally due to generic competition. However, in emerging markets, where generic penetration is growing and healthcare infrastructure is expanding, revenues are projected to sustain a CAGR of approximately 2-3%, driven by increased volume sales.

Pricing Dynamics

Global pricing pressures will continue, especially in high-income countries, where governments negotiate tighter reimbursement rates. Conversely, in emerging economies, pricing remains relatively stable, benefiting volume-driven growth.

Investment in R&D and New Formulations

While traditional cephalexin formulations are near generic saturation, future revenue growth may stem from new delivery forms (e.g., formulations with extended half-life), or combination therapies targeting resistant bacteria, although such innovations are currently limited.

Merger and Acquisition (M&A) Impacts

Strategic partnerships and acquisitions by generic manufacturers in emerging economies could further expand OMNICEF's market presence. Conversely, patent litigations or regulatory barriers could hinder growth.

Key Financial Indicators

• Short-term (2023-2025): Revenue stabilization with slight decline in developed markets; moderate growth in emerging regions.
• Medium-term (2025-2028): Possible decline in mature markets; increased volume sales in expanding markets.
• Profitability: Margins will compress in mature markets but may be bolstered by high-volume sales in emerging regions.

Strategic Opportunities and Risks

Opportunities

• Market Diversification: Expanding into new geographic regions with growing healthcare access.
• Formulation Innovation: Developing extended-release or combination formulations to combat resistant strains.
• Regulatory Navigation: Engaging proactively with regulatory bodies to maintain market access.

Risks

• Antimicrobial Resistance: Diminished efficacy leading to reduced prescription rates.
• Pricing Pressures: Policy-driven price reductions impacting margins.
• Competitive Pressure: Entry of newer antibiotics and generics eroding market share.

Conclusion

OMNICEF’s market dynamics are intricately linked to general antibiotic consumption patterns, resistance trends, and regulatory landscapes. While the drug maintains stable demand in various regions, intensifying generic competition and rising AMR threaten long-term growth. Financial forecasts indicate a plateauing trajectory with limited upside unless innovations or market expansions are successfully executed.

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Key Takeaways

• OMNICEF remains a critical first-line antibiotic, especially in outpatient settings, but faces declining margins due to generic competition and pricing pressures.
• Emerging markets provide growth opportunities driven by healthcare infrastructure expansion and increased antibiotic consumption.
• Antimicrobial resistance threatens to undermine OMNICEF’s efficacy, prompting a need for innovation and stewardship.
• Strategic expansion and formulation development may buffer revenue declines, but risks related to AMR and regulatory changes persist.
• Business decision-makers should prioritize diversification, R&D investments, and regional market penetration to sustain long-term profitability.

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FAQs

1. How will antimicrobial resistance impact OMNICEF’s market share?
AMR diminishes cephalexin’s effectiveness against resistant bacteria, potentially reducing its prescription rates. Sustained resistance trends could lead to decreased market share unless formulations adapted to resistant strains are developed.

2. What are the main growth markets for OMNICEF?
Emerging economies, notably India, China, and Brazil, represent primary growth markets, benefiting from expanding healthcare access, increasing antibiotic demand, and the prevalence of affordable generic options.

3. Are there any new formulations of OMNICEF in development?
Currently, no significant new formulations are publicly announced. Future growth may depend on innovation strategies, such as combination therapies or formulations with extended half-lives.

4. How do regulatory policies influence OMNICEF’s market?
Regulatory bodies’ tightening of antibiotic approval and use restrictions, coupled with anti-antibiotic stewardship efforts, limit overprescription, influencing sales volumes and margins.

5. What strategic moves can manufacturers make to sustain OMNICEF’s profitability?
Manufacturers should focus on market diversification, formulating innovative delivery methods, engaging in strategic alliances, and expanding into regions with rising healthcare infrastructure.

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References

[1] MarketsandMarkets. "Antibiotics Market by Product Type, Route of Administration, and Region — Global Forecast to 2028." 2023.

[2] WHO. "Antimicrobial Resistance Fact Sheet," 2022.