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Last Updated: December 12, 2025

CEPHAPIRIN SODIUM Drug Patent Profile


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When do Cephapirin Sodium patents expire, and what generic alternatives are available?

Cephapirin Sodium is a drug marketed by Abraxis Pharm and Hikma and is included in two NDAs.

The generic ingredient in CEPHAPIRIN SODIUM is cephapirin sodium. There are seven drug master file entries for this compound. Additional details are available on the cephapirin sodium profile page.

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Summary for CEPHAPIRIN SODIUM
Drug patent expirations by year for CEPHAPIRIN SODIUM
Recent Clinical Trials for CEPHAPIRIN SODIUM

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SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

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Medical Subject Heading (MeSH) Categories for CEPHAPIRIN SODIUM

US Patents and Regulatory Information for CEPHAPIRIN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abraxis Pharm CEPHAPIRIN SODIUM cephapirin sodium INJECTABLE;INJECTION 062723-002 Nov 17, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hikma CEPHAPIRIN SODIUM cephapirin sodium INJECTABLE;INJECTION 062720-003 Jul 2, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Abraxis Pharm CEPHAPIRIN SODIUM cephapirin sodium INJECTABLE;INJECTION 062723-005 Nov 17, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hikma CEPHAPIRIN SODIUM cephapirin sodium INJECTABLE;INJECTION 062720-004 Jul 2, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Cephapirin Sodium

Last updated: July 27, 2025

Introduction

Cephapirin sodium, a first-generation cephalosporin antibiotic, plays a critical role in veterinary medicine and certain human applications. Its market has evolved significantly due to regulatory changes, antimicrobial stewardship policies, and the rising demand for effective veterinary antibiotics. This analysis explores the current market landscape, drivers, challenges, and forecasted financial trajectory, providing insights for stakeholders and investors.

Overview of Cephapirin Sodium

Cephapirin sodium, chemically known as cephalosporin C sulfide, is utilized primarily for intramammary infusions in dairy cows to prevent and treat mastitis, a prevalent dairy industry concern [1]. Its spectrum of action and safety profile have cemented its role in veterinary therapeutics. Historically produced by major pharmaceutical manufacturers, cephapirin sodium's formulation and indications have remained relatively stable, though recent shifts in regulations and market dynamics are influencing its trajectory.

Market Size and Segmentation

The global veterinary antibiotics market was valued at approximately USD 7.5 billion in 2020, with cephapirin sodium commanding a modest yet significant share in the intramammary antibiotic segment [2]. The market is segmented by:

  • Application: Mastitis treatment in dairy cattle, other veterinary infections
  • End-user: Veterinary clinics, dairy farms, pharmaceutical companies
  • Region: North America, Europe, Asia-Pacific, Latin America, MEA

North America and Europe constitute mature markets, driven by advanced veterinary infrastructure and strict regulations. Asia-Pacific exhibits high growth potential driven by expanding dairy farming and increasing livestock disease incidences.

Market Drivers

Regulatory Environment and Veterinary Practices

Stringent regulations aiming to control antimicrobial use directly influence cephapirin sodium’s market. Agencies like the FDA’s Center for Veterinary Medicine (CVM) have implemented guidelines to limit antibiotic residues in dairy products, affecting approvals and usage protocols [3].

Rising Prevalence of Mastitis

The global increase in dairy herd sizes and the prevalence of mastitis make antibiotics like cephapirin sodium essential. Mastitis causes significant economic losses—estimated at USD 2 billion annually in the US alone [4]—prompting continued demand for effective intramammary treatments.

Antimicrobial Stewardship and Resistance Concerns

While stewardship initiatives aim to reduce antibiotic use, they simultaneously emphasize the importance of targeted treatments. Cephapirin sodium’s traditional role remains relevant due to its narrow spectrum and efficacy, aligning with these initiatives to reduce broader-spectrum antibiotic use.

Technological Advancements

Innovation in drug formulation, such as sustained-release preparations, enhances efficacy and compliance, fostering market stability.

Market Challenges

Regulatory Restrictions

Recent bans and restrictions on certain antibiotics, including cephapirin derivatives, in various jurisdictions pose a threat. For instance, the European Union has banned the use of antibiotics as growth promoters, although this pertains more to feed additives than direct therapeutics [5].

Antimicrobial Resistance (AMR) Concerns

Global efforts to combat AMR have led to tighter regulations. Reduced approval pathways for certain antibiotics and increased monitoring impact market access and profitability.

Competition from Alternative Therapies

Emerging therapies, including vaccine-based prevention of mastitis and non-antibiotic treatments, threaten long-term demand for traditional antibiotics like cephapirin sodium.

Financial Trajectory and Forecast

Current Revenue Streams

In 2021, the segment of veterinary intramammary antibiotics was estimated at USD 1 billion globally, with cephapirin sodium representing a notable proportion owing to its established efficacy [2].

Projection Through 2030

The market for cephapirin sodium is projected to grow at a compound annual growth rate (CAGR) of approximately 3-4% over the next decade, driven by rising dairy farm sizes in emerging markets and incremental replacements of older antibiotics with newer formulations.

However, growth may be tempered by regulatory tightening and alternative treatment modalities. The Asia-Pacific region is expected to lead growth, with CAGR reaching up to 5%, owing to expanding dairy industries and less stringent regulatory frameworks initially [6].

Impact of Regulatory Changes

Anticipated bans or phase-outs of specific antibiotics would negatively impact revenue. Conversely, adoption of approved, residue-free formulations and improved export standards could sustain revenues.

Market Entry and Investment Opportunities

Pharmaceutical firms investing in novel, resistant-defying formulations of cephapirin sodium or expanding authorized indications could enhance financial trajectories. Strategic partnerships with veterinary distributors are vital to penetrate emerging markets.

Strategic Outlook

To capitalize on future opportunities, stakeholders must:

  • Align with evolving regulations, emphasizing safety and residue-free products.
  • Invest in R&D to develop advanced formulations, such as sustained-release or combination therapies.
  • Expand presence in high-growth regions, leveraging local dairy industry growth.

Key Market Trends

  • Shift Toward Responsible Antibiotic Use: Trends favor targeted, limited-duration therapies.
  • Regulatory Harmonization: Increasing international standards for veterinary antibiotics promote product standardization.
  • Increased Focus on Animal Welfare: Demand for effective, safe therapeutics increases market stability.
  • Innovation in Delivery Methods: Development of gel, infusion, or sustained-release formats elevates treatment adherence and efficacy.

Conclusion

The market for cephapirin sodium is characterized by incremental growth, moderated by regulatory scrutiny and technological evolution. Stakeholders who adapt to these dynamics—through innovation, regulatory compliance, and expansion into high-growth markets—will favorably influence their financial trajectories.


Key Takeaways

  • Cephapirin sodium remains vital in veterinary mastitis management, with a stable yet evolving market landscape.
  • Market growth is steady, with a CAGR of approximately 3-4%, driven primarily by emerging markets and technological innovations.
  • Regulatory changes, especially antimicrobial stewardship initiatives, pose both challenges and opportunities for product development.
  • Opportunities exist in developing advanced formulations and expanding geographic footprint, notably in Asia-Pacific.
  • Vigilance regarding antimicrobial resistance policies and alternative therapies is essential for strategic planning.

FAQs

1. How does regulatory pressure affect the future market for cephapirin sodium?
Regulatory agencies' increasingly stringent policies on antibiotic use aim to curb antimicrobial resistance, potentially limiting market access and usage of cephapirin sodium. However, compliant formulations and residue-free products can mitigate impact, enabling continued market presence.

2. What are the main competitors to cephapirin sodium in veterinary mastitis treatment?
Competitors include other first-generation cephalosporins, penicillins, and non-antibiotic alternatives like vaccines and teat sealants designed for mastitis prevention. The choice depends on regional approval status, efficacy, cost, and residue considerations.

3. Is the demand for cephapirin sodium expected to decline due to alternative therapies?
While emerging alternatives may reduce long-term reliance, cephapirin sodium's proven efficacy ensures it remains relevant, especially where regulatory and economic factors favor traditional antibiotics. Its niche in approved, residue-free formulations sustains demand.

4. Which regions present the most growth opportunities for cephapirin sodium?
Asia-Pacific offers significant growth potential owing to expanding dairy industries and less restrictive regulations. Latin America and parts of Africa also provide opportunities driven by increasing livestock populations.

5. What strategic moves should pharmaceutical companies consider to maximize profitability?
Investing in improved formulations, ensuring compliance with local regulations, expanding into high-growth markets, and establishing collaborations with veterinary service providers are key strategies for maximizing profitability.


Sources Cited

[1] American Veterinary Medical Association. Veterinary Uses of Cephalosporins. 2021.

[2] MarketsandMarkets. Veterinary Antibiotics Market by Product, Application, and Region. 2022.

[3] U.S. Food and Drug Administration. Draft Guidance for Industry: Antimicrobial Use in Veterinary Medicine. 2021.

[4] USDA. Economic Impact of Mastitis in Dairy Cattle. 2019.

[5] European Commission. Regulation (EC) No 1831/2003 on additives for use in animal nutrition. 2003.

[6] Grand View Research. Veterinary Drugs Market Size, Share & Trends. 2021.

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