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Last Updated: December 22, 2024

KEFUROX Drug Patent Profile


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

Kefurox is a drug marketed by Acs Dobfar and Lilly and is included in three NDAs.

The generic ingredient in KEFUROX is cefuroxime sodium. There are sixty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Kefurox

A generic version of KEFUROX was approved as cefuroxime sodium by ACS DOBFAR SPA on May 30th, 1997.

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Summary for KEFUROX
US Patents:0
Applicants:2
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 88
Patent Applications: 46
DailyMed Link:KEFUROX at DailyMed
Drug patent expirations by year for KEFUROX

US Patents and Regulatory Information for KEFUROX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acs Dobfar KEFUROX cefuroxime sodium INJECTABLE;INJECTION 062591-002 Jan 10, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lilly KEFUROX IN PLASTIC CONTAINER cefuroxime sodium INJECTABLE;INTRAVENOUS 062590-001 Jan 10, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Acs Dobfar KEFUROX cefuroxime sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 062591-001 Jan 10, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Acs Dobfar KEFUROX cefuroxime sodium INJECTABLE;INJECTION 062591-003 Dec 17, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lilly KEFUROX cefuroxime sodium INJECTABLE;INJECTION 062592-002 Jan 10, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

KEFUROX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cephalosporin Antibiotics: A Case Study of Kefurox

Introduction

Cephalosporin antibiotics, such as Kefurox (also known as Cefuroxime), are a class of beta-lactam antibiotics widely used to treat various bacterial infections. To understand the market dynamics and financial trajectory of Kefurox, we need to delve into the broader context of the cephalosporin market, industry trends, and the specific performance of this drug.

Overview of Cephalosporin Antibiotics

Cephalosporins are a crucial class of antibiotics, known for their broad-spectrum activity against both Gram-positive and Gram-negative bacteria. They have been a cornerstone in the treatment of bacterial infections for decades[5].

Market Trends in Prescription Drug Spending

The overall market for prescription drugs has seen significant growth. Between 2016 and 2021, total inflation-adjusted expenditures on prescription drugs increased from $520 billion to $603 billion, a 16% increase. This growth was driven more by increases in spending per prescription rather than the number of prescriptions filled[1].

Retail vs. Non-Retail Drug Spending

In the context of cephalosporin antibiotics like Kefurox, it is important to distinguish between retail and non-retail drug spending. Retail drug expenditures represented about 70% of prescription drug spending, while non-retail expenditures accounted for the remaining 30%. Non-retail drug spending, which includes hospital and clinic settings, saw a 25% increase between 2016 and 2021, driven primarily by greater utilization rather than higher drug prices[1].

Specialty and High-Cost Drugs

Specialty drugs, which include some cephalosporins due to their advanced formulations and high costs, have also seen significant growth. Specialty drug spending increased by 43% between 2016 and 2021, reaching $301 billion in 2021. Despite a minimal increase in the number of specialty prescriptions, the spending per prescription rose substantially[1].

Generic Drug Market Dynamics

The generic drug market plays a crucial role in the financial trajectory of drugs like Kefurox. Generic drug prices decline with the number of competitors, approaching long-run marginal costs when there are eight or more competitors. This competition can significantly impact the revenues of brand-name drugs once their patents expire[3].

Authorized Generic Drugs

Authorized generic drugs (AGs), which are brand-name drugs marketed as generics, can also affect the market dynamics. AGs during the 180-day exclusivity period can reduce retail generic prices by 4-8% and wholesale prices by 7-14% compared to prices without AG competition. This can reduce the revenues of the first-filer generic manufacturer by 40-52% during the exclusivity period and persistently affect their revenues afterward[4].

Eli Lilly and the Cephalosporin Market

Eli Lilly, a major pharmaceutical company, has historically been dominant in the cephalosporin market. The company's investment in research and development led to the introduction of new cephalosporins like Ceclor, Dobutrex, and Mandol, which helped recapture market share threatened by competition from other firms[2].

Financial Trajectory of Kefurox

Patent Expiration and Generic Competition

Kefurox, like other cephalosporins, faces significant financial challenges once its patent expires. The entry of generic competitors can drastically reduce the drug's market share and revenue. For instance, generic drug prices are 35-50% above long-run marginal costs for the initial generic monopolist but decline as more competitors enter the market[3].

Market Share and Revenue

Before the patent expiration, Kefurox would have enjoyed a substantial market share and revenue as a brand-name drug. However, post-patent expiration, the revenue would decline sharply due to generic competition. The presence of authorized generics can further exacerbate this decline by reducing prices and capturing a portion of the market share[4].

Impact of Specialty Drug Trends

If Kefurox is classified as a specialty drug due to its formulation or delivery method, it might benefit from the growing trend in specialty drug spending. However, this would also mean higher development and marketing costs to maintain its position in the market[1].

Case Study: Eli Lilly’s Experience

Eli Lilly’s experience with cephalosporins provides valuable insights. The company’s success with new cephalosporins like Ceclor and Mandol highlights the importance of continuous innovation and market adaptation. Despite facing competition and patent expirations, Lilly managed to maintain its market position through strategic diversification and R&D investments[2].

Key Takeaways

  • Market Growth: Prescription drug spending, including cephalosporins, has seen steady growth driven by increases in spending per prescription.
  • Generic Competition: The entry of generic competitors significantly impacts the financial trajectory of brand-name drugs like Kefurox.
  • Authorized Generics: AGs can reduce prices and capture market share, affecting the revenues of both brand-name and generic manufacturers.
  • Specialty Drugs: Classification as a specialty drug can influence the financial performance but also involves higher costs.
  • Innovation and Adaptation: Continuous R&D and strategic diversification are crucial for maintaining market position in the face of competition and patent expirations.

FAQs

What is the impact of generic competition on brand-name drugs like Kefurox?

Generic competition significantly reduces the market share and revenue of brand-name drugs. Prices decline as more generic competitors enter the market, approaching long-run marginal costs with eight or more competitors[3].

How do authorized generic drugs affect the market?

Authorized generic drugs can reduce retail and wholesale prices, capturing market share and reducing the revenues of the first-filer generic manufacturer by 40-52% during the exclusivity period and beyond[4].

What is the trend in specialty drug spending?

Specialty drug spending has increased substantially, with a 43% growth between 2016 and 2021. This trend can benefit drugs like Kefurox if they are classified as specialty drugs, but it also involves higher development and marketing costs[1].

How does patent expiration affect the financial trajectory of a drug?

Patent expiration leads to a sharp decline in revenue due to the entry of generic competitors. This decline can be exacerbated by the presence of authorized generics[3][4].

What strategies can pharmaceutical companies use to maintain market position post-patent expiration?

Companies can maintain their market position through continuous innovation, R&D investments, and strategic diversification into other product lines, as exemplified by Eli Lilly’s approach[2].

Sources

  1. Trends in Prescription Drug Spending, 2016-2021 - ASPE
  2. Eli Lilly & Company - Encyclopedia.com
  3. Generic Drug Industry Dynamics - Federal Trade Commission
  4. Authorized Generic Drugs: Short-Term Effects and Long-Term Impact - Federal Trade Commission
  5. Cephalosporins as key lead generation beta-lactam antibiotics - ResearchGate

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