You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 17, 2025

CEPHRADINE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


Summary for CEPHRADINE
US Patents:0
Tradenames:6
Applicants:8
NDAs:15
Drug Master File Entries: 10
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 8,183
DailyMed Link:CEPHRADINE at DailyMed
Medical Subject Heading (MeSH) Categories for CEPHRADINE

US Patents and Regulatory Information for CEPHRADINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva CEPHRADINE cephradine FOR SUSPENSION;ORAL 062693-001 Jan 9, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Apothecon VELOSEF cephradine INJECTABLE;INJECTION 061976-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Apothecon VELOSEF '125' cephradine FOR SUSPENSION;ORAL 061763-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Apothecon VELOSEF cephradine INJECTABLE;INJECTION 061976-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Apothecon VELOSEF cephradine INJECTABLE;INJECTION 061976-005 Approved Prior to Jan 1, 1982 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 the Pharmaceutical Drug: Cephradine

Last updated: July 27, 2025


Introduction

Cephradine, a first-generation cephalosporin antibiotic, has historically played a foundational role in antimicrobial therapy. Its efficacy against a broad spectrum of bacterial pathogens, combined with favorable pharmacokinetics, made it a staple in clinical settings during the late 20th century. While advancements in antibiotic development have shifted prescribing patterns, understanding its market dynamics and financial trajectory remains vital for stakeholders navigating the evolving pharmaceutical landscape.


Historical Context and Clinical Utility

Cephradine, introduced in the 1970s, marked a significant point in the evolution of β-lactam antibiotics. Its mechanism involves inhibiting bacterial cell wall synthesis, which confers broad antibacterial activity. Its affordability and efficacy initially led to widespread adoption across hospital and outpatient settings globally. The drug was typically prescribed for respiratory tract infections, urinary tract infections, and soft tissue infections.

However, the rise of resistance, particularly extended-spectrum β-lactamases (ESBLs) and other resistant strains, began to limit its clinical utility by the late 2000s. Despite this, cephradine remains in use, especially in markets where newer agents are either unavailable or cost-prohibitive.


Market Dynamics

Global Market Overview

The global antibiotic market stood at approximately USD 47 billion in 2021, with cephalosporins accounting for a significant share of this volume[1]. First-generation cephalosporins like cephradine represent a smaller segment within this, mainly driven by regional prescribing habits, generic manufacturing, and antimicrobial stewardship programs.

The core markets include:

  • Asia-Pacific: High prevalence of infectious diseases and large patient populations sustain demand. Countries like India, China, and Southeast Asian nations still rely heavily on older antibiotics due to cost factors and widespread use in outpatient settings.

  • Europe and North America: Stricter antimicrobial stewardship initiatives, evolving treatment guidelines favoring newer agents, and concern over resistance have curtailed growth for cephradine.

Market Drivers

  • Cost Effectiveness: Cephradine remains a low-cost antibiotic, crucial for low- and middle-income countries (LMICs). Governments and healthcare providers prioritize affordable therapies, supporting continued use.

  • Regulatory Approvals: Generic labeling and regulatory approvals in multiple countries have kept the product accessible, albeit with declining prescriptions.

  • Infection Patterns: The persistent burden of bacterial infections, particularly where resistance is less widespread, sustains demand in specific regions.

Market Constraints

  • Antimicrobial Resistance (AMR): The negative impact of AMR has led to reduced prescriptions of broad-spectrum and older antibiotics like cephradine.

  • Emergence of Newer Antibiotics: Fourth- and fifth-generation cephalosporins, carbapenems, and combination therapies are often preferred due to better efficacy profiles and resistance management.

  • Stringent Guidelines: Updated clinical guidelines discourage the routine use of first-generation cephalosporins for many indications, favoring more targeted agents.


Financial Trajectory

Growth Trends

Historically, cephradine experienced consistent growth during the late 20th century, primarily driven by the expansion of global healthcare infrastructure and high demand for affordable antibiotics. From the early 2000s onward, this trajectory plateaued and subsequently declined in markets with advanced healthcare systems.

  • Regional Variations: The drug's residual demand persists in LMICs. For instance, in India, cephradine remains one of the commonly prescribed antibiotics, supporting a steady revenue stream for local generics manufacturers.

Pricing Dynamics

The commoditized nature of cephradine, compounded by the availability of multiple generic manufacturers, has resulted in highly competitive pricing. The average wholesale price (AWP) declines further as patent protections have long expired, leading to razor-thin margins for producers.

Market Penetration and Revenue Potential

In high-income markets, the revenue contribution from cephradine is diminishing. Conversely, in LMICs, it remains a cost-effective option, making it attractive for local producers expanding in these regions. Current estimates suggest its global market share in antibiotics has decreased by approximately 15–20% over the past decade[2].

Pipeline and Future Outlook

No significant new formulations or indications are under active development for cephradine. Its role is progressively replaced by agents with better resistance profiles and pharmacokinetics. Nevertheless, its presence in the formulary persists through existing generics, sustaining minimal but stable revenue streams.


Regulatory and Commercial Challenges

  • Antibiotic Stewardship Policies: Growing emphasis on responsible antibiotic use advocates for limiting the use of older antibiotics. This trend accelerates the decline in cephradine prescriptions.

  • Resistance Monitoring: Rising resistance diminishes clinical efficacy, prompting healthcare providers to favor newer, broader-spectrum antibiotics.

  • Generic Market Saturation: Intense competition among generics providers results in commoditization, pressuring prices downward and reducing profit margins.


Opportunities and Strategic Outlook

  • Focus on LMIC Markets: Manufacturers utilizing cost-effective production can leverage demand stability in emerging markets.

  • Combination Therapies: Potential exists to develop fixed-dose combinations with other antibiotics to extend utility.

  • Niche Indications: Limited indications, such as specific skin infections or prophylactic use in surgeries, may continue supporting niche markets.


Key Takeaways

  • Cephradine's market landscape is characterized by decreasing global demand, primarily due to rising antimicrobial resistance, evolving clinical guidelines, and the emergence of newer agents.

  • The drug remains economically vital for LMICs given its affordability, sustaining a segmented but stable market segment.

  • Competition among generics has driven prices to minimal levels, constraining profit margins for producers.

  • Strategic focus on emerging markets and niche indications may prolong cephradine’s commercial viability.

  • The overall financial trajectory suggests a gradual decline, with future growth prospects limited without significant innovation or repositioning.


FAQs

1. Is cephradine still widely used today?
While its use has declined in high-income countries due to resistance and newer alternatives, cephradine remains in use primarily in LMICs where cost considerations dominate prescribing practices.

2. What are the primary competitors to cephradine?
Other first-generation cephalosporins like cephalexin and cefadroxil, along with broader-spectrum antibiotics, compete with cephradine, further diminishing its market share.

3. How does antimicrobial resistance impact cephradine’s market?
Rising resistance reduces clinical efficacy, leading to decreased prescriptions and increased reliance on newer antibiotics, thereby negatively influencing market stability.

4. Are there ongoing efforts to develop derivatives or formulations of cephradine?
Currently, no significant development pipeline exists for cephradine derivatives, reflecting the broader shift away from first-generation cephalosporins toward more advanced agents.

5. What strategic approaches can manufacturers adopt to sustain cephradine sales?
Focusing on emerging markets, exploring niche therapeutic indications, and developing combination formulations are potential strategies to prolong market relevance.


References

[1] Grand View Research. Antibiotics Market Analysis, 2022.
[2] IQVIA. Global Antibiotic Market Report, 2021.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.