You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 15, 2025

ANCEF Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Ancef patents expire, and when can generic versions of Ancef launch?

Ancef is a drug marketed by Glaxosmithkline and Baxter Hlthcare and is included in three NDAs.

The generic ingredient in ANCEF is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ancef

A generic version of ANCEF was approved as cefazolin sodium by SANDOZ on December 9th, 1988.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ANCEF?
  • What are the global sales for ANCEF?
  • What is Average Wholesale Price for ANCEF?
Summary for ANCEF
US Patents:0
Applicants:2
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 70
Patent Applications: 4,006
DailyMed Link:ANCEF at DailyMed
Drug patent expirations by year for ANCEF

US Patents and Regulatory Information for ANCEF

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline ANCEF cefazolin sodium INJECTABLE;INJECTION 050461-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER cefazolin sodium INJECTABLE;INJECTION 050566-004 Jun 8, 1983 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Glaxosmithkline ANCEF cefazolin sodium INJECTABLE;INJECTION 050461-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare ANCEF IN PLASTIC CONTAINER cefazolin sodium INJECTABLE;INJECTION 063002-001 Mar 28, 1991 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Glaxosmithkline ANCEF cefazolin sodium INJECTABLE;INJECTION 050461-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Glaxosmithkline ANCEF cefazolin sodium INJECTABLE;INJECTION 050461-005 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER cefazolin sodium INJECTABLE;INJECTION 050566-003 Jun 8, 1983 DISCN Yes 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: ANCEF

Last updated: July 27, 2025

Introduction

Ancef (generic name: cefazolin) is a first-generation cephalosporin antibiotic extensively utilized in the prevention and treatment of bacterial infections. Approved by the FDA in the 1970s, Ancef remains a cornerstone in antimicrobial therapy, especially in surgical prophylaxis and for susceptible infections. Its market dynamics and financial trajectory are influenced by multifaceted factors, including regulatory landscapes, emerging antimicrobial resistance (AMR), competitive pressures, and evolving healthcare protocols.

Market Landscape and Demand Drivers

Global Antibiotics Market Overview

The global antibiotics market was valued at approximately USD 55 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 3.5% through 2030 [1]. Ancef's core market resides within this landscape, with dominant demand in developed regions due to established healthcare infrastructures and catalyst factors such as surgical procedures, hospital-acquired infections, and the prevalence of bacterial pathogens.

Key Demand Drivers for Ancef

  1. Surgical Prophylaxis: As surgical procedures increase worldwide, especially in emerging markets, prophylactic use of cefazolin remains standard practice, bolstering steady demand.
  2. Hospital-Acquired Infections (HAIs): The rising incidence of HAIs, including surgical site infections, urinary tract infections, and pneumonia, sustains the need for effective antibiotic agents like Ancef.
  3. Regulatory Acceptance and Guidelines: Recommendations from entities such as the CDC and WHO advocate for cefazolin as a first-line agent in various infections, consolidating its clinical relevance.
  4. Antimicrobial Stewardship Programs: While promoting appropriate use, these programs often endorse first-generation cephalosporins for specific bacterial strains, maintaining its market presence.

Market Challenges and Competitive Dynamics

Antimicrobial Resistance (AMR)

A pivotal challenge facing Ancef is the rising AMR, particularly among pathogens such as Escherichia coli, Klebsiella pneumoniae, and Staphylococcus aureus. The emergence of multidrug-resistant organisms diminishes cefazolin's efficacy, prompting clinicians to seek alternative agents. Reports indicate increasing resistance rates in gram-negative bacteria, which compromise Ancef's utility in certain indications [2].

Competition from Preservative and Broad-Spectrum Antibiotics

The market shares of carbapenems, fluoroquinolones, and newer cephalosporins continue to expand, driven by their broader spectrum and efficacy against resistant strains. Despite this, cefazolin retains competitiveness in specific niches due to its narrow spectrum, safety profile, and cost-effectiveness.

Generic Availability and Pricing Pressures

Since patent expirations in the late 1990s, Ancef has been available as a generic, resulting in significant price erosion. Moreover, commoditization exerts downward pressure on margins, although stable demand ensures persistent revenue streams.

Regulatory and Policy Environment

Regulatory decisions and policies significantly influence Ancef’s market trajectory. Ongoing initiatives to combat AMR, such as stewardship policies restricting overuse, could limit prescriptions. Conversely, the approval of new indications or formulations—such as liposomal cefazolin—may expand the product’s reach.

Moreover, patenting of formulations and delivery mechanisms remains a strategic area; however, with Ancef’s generics dominance, patent protections are minimal. Market access and formulary placement are increasingly governed by hospital procurement policies, community stewardship, and payer dynamics.

Financial Trajectory: Revenue and Profitability Outlook

Historical Revenue Trends

Leading manufacturers, such as Pfizer and Sandoz, have reported steady revenues from cefazolin sales, although with gradual decline attributable to generic market saturation [3]. For example, Pfizer’s Hospital Products segment recorded $X million in cefazolin-containing products in 2021, reflecting mature market dynamics.

Forecasted Growth and Decline Factors

  1. Stable Core Demand: In surgical prophylaxis and certain infections, demand remains resilient, providing predictable revenue streams.
  2. Impact of Resistance and Stewardship: Rising resistance may necessitate shifts toward alternative agents, potentially reducing cefazolin sales over the long term.
  3. Novel Formulations: Development of enhanced formulations, such as liposomal cefazolin or combination therapies, could rejuvenate market interest and expand patient populations.

Market Expansion Opportunities

  • Emerging Markets: Growing healthcare infrastructure and surgical procedures could accelerate cefazolin use, especially if aligned with local antimicrobial guidelines.
  • Biosimilars and Generics: Increased production of generic cefazolin variants can sustain profitability through high-volume, low-margin sales.
  • Indicative M&A Activity: Strategic acquisitions and partnerships might facilitate entry into unexplored markets or development of innovative formulations, influencing financial performance.

Emerging Trends Influencing the Market

  1. Precision Antibiotic Therapy: Advances in diagnostic tools enabling targeted therapy favor narrow-spectrum agents like Ancef.
  2. Regulatory Incentives: Incentives promoting antimicrobial development may stimulate innovation around cefazolin derivatives.
  3. Global Public Health Initiatives: Concerted efforts to curb overuse and resistance could reshape prescribing behaviors, impacting Ancef’s sales volume.

Conclusion: Strategic Outlook

While the direct financial trajectory of Ancef remains characterized by stability due to established demand, its future is intricately linked to broad healthcare trends. Resistance dynamics, regulatory shifts, and competitive innovations shape its market position. Manufacturers seeking sustained profitability should focus on expanding indications, investing in formulation innovations, and navigating stewardship policies adeptly.

Key Takeaways

  • Stable Core Demand: Ancef continues to be essential in surgical prophylaxis and susceptible bacterial infections, ensuring consistent revenue.
  • Resistance Challenges: Rising AMR threatens its efficacy, potentially leading to reduced prescribing and necessitating innovation.
  • Generics Saturation: Widespread generic availability has diminished profit margins but supports volume-driven revenue.
  • Market Expansion Potential: Emerging markets and new formulations offer opportunities for growth, contingent on regulatory approvals and clinical adoption.
  • Strategic Positioning: Success depends on balancing stewardship, innovation, and market access strategies to sustain financial performance.

FAQs

1. How does antimicrobial resistance impact the future sales of Ancef?
AMR reduces cefazolin’s efficacy against certain pathogens, leading clinicians to prefer broader-spectrum or newer agents. Consequently, over time, resistance may diminish Ancef’s market share unless new formulations or indications are introduced.

2. Are there ongoing developments to improve Ancef’s therapeutic profile?
Yes. Research into liposomal formulations and combination therapies aims to enhance pharmacokinetics and efficacy, potentially expanding its utility against resistant strains.

3. How significant is the role of emerging markets in Ancef’s long-term financial outlook?
Emerging markets present growth opportunities due to increasing surgical activity and expanding healthcare infrastructure. However, local regulation, resistance patterns, and formulary preferences influence actual sales.

4. What competitive pressures are most influential for Ancef?
The main pressures stem from broad-spectrum antibiotics like carbapenems, fluoroquinolones, and newer cephalosporins. Price competition from generics and shifts in prescribing guidelines also impact sales.

5. How can pharmaceutical companies extend Ancef’s market lifespan?
Strategies include developing novel formulations, securing expanded indications, aligning with antimicrobial stewardship programs, and targeting underserved markets with tailored clinical guidelines.


References

  1. MarketsandMarkets. “Antibiotics Market by Type, Application, and Region.” 2022.
  2. Centers for Disease Control and Prevention (CDC). “Antibiotic Resistance Threats in the United States,” 2019.
  3. Pfizer Annual 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.