Cefdinir - Generic Drug Details

What are the generic sources for cefdinir and what is the scope of patent protection?

Cefdinir is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Anda Repository, Aurobindo Pharma, Chartwell Rx, Lupin, Teva Pharms, and Abbvie, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for cefdinir. Twenty-seven suppliers are listed for this compound.

Summary for cefdinir

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	14
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	27
Patent Applications:	7,658
Drug Prices:	Drug price trends for cefdinir
Drug Sales Revenues:	Drug sales revenues for cefdinir
What excipients (inactive ingredients) are in cefdinir?	cefdinir excipients list
DailyMed Link:	cefdinir at DailyMed

See drug prices for cefdinir

See drug sales revenues for cefdinir

Recent Clinical Trials for cefdinir

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 4
Northeast Ohio Medical University	Phase 2
Mercy Health Ohio	Phase 2

See all cefdinir clinical trials

Pharmacology for cefdinir

Drug Class

Cephalosporin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for cefdinir

J01DD	Third-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for cefdinir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	CEFDINIR	cefdinir	FOR SUSPENSION;ORAL	065473-002	Dec 14, 2007	AB	RX	No	Yes
Chartwell Rx	CEFDINIR	cefdinir	FOR SUSPENSION;ORAL	065337-002	Apr 6, 2007	AB	RX	No	No
Anda Repository	CEFDINIR	cefdinir	FOR SUSPENSION;ORAL	065429-002	Jul 18, 2007	AB	RX	No	No
Alkem Labs Ltd	CEFDINIR	cefdinir	FOR SUSPENSION;ORAL	210534-001	Feb 19, 2021	AB	RX	No	No

Expired US Patents for cefdinir

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

Market Dynamics and Financial Trajectory for Cefdinir

Last updated: August 19, 2025

Introduction

Cefdinir, a third-generation orally administered cephalosporin antibiotic, has become a prominent asset within the antimicrobial pharmacopeia. Its broad-spectrum activity against a variety of bacterial pathogens, along with its favorable dosing profile, has cemented its role in treating respiratory tract infections, otitis media, and skin infections. This analysis examines the current market dynamics and future financial trajectory of Cefdinir, considering competitive landscape shifts, regulatory factors, epidemiological trends, and evolving prescribing behaviors.

Pharmacological Profile and Clinical Positioning

Cefdinir, marketed under brand names such as Omnicef and generic formulations, exhibits potent activity against Gram-positive bacteria, including Streptococcus pneumoniae, and select Gram-negative pathogens like Haemophilus influenzae. Its once-daily oral dosing enhances patient compliance, contributing to its widespread use in outpatient settings. The drug's safety profile is well-established, supporting broad prescribing across pediatric and adult populations.

The clinical adoption of Cefdinir is largely driven by the increasing prevalence of upper respiratory infections and the rising resistance to older agents like amoxicillin. Its versatility in empirical therapy has fostered consistent demand, although its utilization is influenced by clinical guidelines and antimicrobial stewardship initiatives.

Market Size and Segmentation

The global antibiotics market is projected to surpass USD 53 billion annually by 2027, with cephalosporins accounting for a significant share—estimated at approximately 18% [1]. Cefdinir's segment primarily comprises pediatric prescriptions, with the United States being the dominant market due to high childhood infection rates and established prescribing protocols. Emerging markets in Asia-Pacific and Latin America are experiencing rapid growth, driven by expanding healthcare infrastructure and antibiotic availability.

Segment-specific demand is influenced by factors such as:

• Age demographics: Pediatric populations substantially contribute to Cefdinir's sales.
• Infection prevalence: Seasonal spikes in respiratory infections affect sales cycles.
• Prescribing practices: Preference shifts toward topical and targeted therapies impact oral cephalosporin usage.

Competitive Landscape

Cefdinir faces competition from both branded and generic antibiotics, including amoxicillin-clavulanate, azithromycin, and other third-generation cephalosporins such as cefdinir's close cousin, cefixime. The generic manufacturing sector’s expansion has intensified price competition, exerting downward pressure on margins.

Notably, emerging oral antibiotics such as lefamulin and omadacycline are entering the market with potential to challenge traditional agents like Cefdinir in specific indications. Additionally, the increasing adoption of rapid diagnostic tools influences prescriber preferences towards narrow-spectrum agents, potentially impacting Cefdinir's market share.

Regulatory and Safety Considerations

Regulatory bodies like the U.S. Food and Drug Administration (FDA) require ongoing safety monitoring, especially concerning adverse effects like diarrhea, hypersensitivity, and potential for Clostridioides difficile infections. Recent updates emphasizing antimicrobial stewardship aim to mitigate overprescription, affecting Cefdinir's demand.

Furthermore, resistance development warrants close surveillance. While Cefdinir remains effective against many pathogens, increasing resistance among certain bacterial strains necessitates cautious use and influences prescribing guidelines.

Epidemiological Trends and Impact

The rising incidence of respiratory infections—both viral and bacterial—in pediatric and adult populations sustains Cefdinir demand. However, viral etiology predominates many respiratory illnesses, leading to potential misuse of antibiotics. The awareness campaigns and guidelines emphasizing judicious antibiotic use are gradually shaping prescribing behavior, which could modulate Cefdinir's market growth.

The COVID-19 pandemic further impacted demand dynamics, with a temporary decline in outpatient prescriptions during lockdowns, followed by a resurgence driven by unmet bacterial infection needs post-pandemic.

Financial Trajectory

Historical Performance

Over the past decade, Cefdinir has experienced stable demand, primarily in developed markets. Revenue figures align closely with antibiotic market trends, with growth driven by increased access to healthcare and pediatric vaccination programs reducing the incidence of complex infections. Generic availability has suppressed pricing, but volume-based growth has maintained revenue streams.

Projected Growth

The global Cefdinir market is expected to grow at a Compound Annual Growth Rate (CAGR) of approximately 3.2% from 2023 to 2028, with key growth contributors including:

• Emerging markets: Rapid urbanization and healthcare infrastructure development will expand access.
• Expanded indications: Off-label uses and longer treatment courses in certain infections could boost demand.
• Regulatory approvals: New formulations or combinations may extend patent life or open new segments.

Potential Risks to Financial Trajectory

• Antimicrobial stewardship policies: Stricter guidelines could limit Cefdinir prescribing, particularly for conditions where it is not first-line.
• Resistance patterns: Growing resistance could diminish efficacy, necessitating shifts to alternative therapies and impacting revenue.
• Competitive innovations: Introduction of newer antibiotics with improved efficacy or safety profiles may erode Cefdinir’s market share.

Strategic Implications

Pharmaceutical companies operating in this space should prioritize:

• Investing in surveillance and stewardship programs to preserve Cefdinir’s efficacy.
• Developing formulations that meet patient and clinician preferences, including pediatric-friendly options.
• Engaging with regulators and health authorities to align on guidelines that sustain appropriate Cefdinir use.
• Expanding geographic reach via partnerships and local manufacturing to capitalize on emerging market growth.

Conclusion

Cefdinir’s market remains resilient, supported by its clinical profile and ongoing demand in outpatient settings. Nevertheless, its future financial trajectory faces challenges from evolving prescribing practices, resistance, and competition from emerging antibiotics. Strategic adaptation—focused on stewardship, innovation, and geographic expansion—will determine long-term profitability.

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Key Takeaways

• The global Cefdinir market is projected to grow modestly at 3.2% CAGR through 2028, driven by emerging markets and expanding indications.
• Competitive pressures, resistance development, and antimicrobial stewardship are the primary risks influencing Cefdinir’s market size and profitability.
• Patent expirations and generic proliferation exert downward pricing pressure but are offset by maintained volume demand.
• Regulatory focus on appropriate antibiotic use supports sustained demand in compliant markets, though overuse remains a concern.
• Strategic investments in formulation innovation, surveillance, and geographic expansion are critical for maintaining market relevance.

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FAQs

1. What factors influence Cefdinir’s market growth?
   Demand is primarily driven by the prevalence of bacterial respiratory infections, pediatric healthcare access, and prescribing habits. Emerging markets and expanding indications also contribute to growth.

2. How does antibiotic resistance impact Cefdinir?
   Increasing resistance among key pathogens can reduce Cefdinir’s efficacy, leading to decreased prescribing and potential development of new formulations or combination therapies.

3. What regulations affect Cefdinir’s market?
   Authorities emphasize antimicrobial stewardship, safety monitoring, and appropriate prescribing practices, all of which can influence market access and demand.

4. Are there upcoming competitors to Cefdinir?
   Yes. Newer oral antibiotics like lefamulin and omadacycline could compete for certain indications, potentially affecting Cefdinir’s market share.

5. What strategies can pharmaceutical companies adopt to sustain Cefdinir’s market?
   Emphasize stewardship programs, develop patient-friendly formulations, expand to emerging markets, and monitor resistance trends to adapt usage guidelines proactively.

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References

[1] MarketsandMarkets. (2022). Antibiotics Market by Type, Application, and Region — Global Forecast to 2027.