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Last Updated: December 22, 2024

TOTACILLIN-N Drug Patent Profile


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When do Totacillin-n patents expire, and when can generic versions of Totacillin-n launch?

Totacillin-n is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in TOTACILLIN-N is ampicillin sodium. There are seventy drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Totacillin-n

A generic version of TOTACILLIN-N was approved as ampicillin sodium by SANDOZ on February 19th, 1987.

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Summary for TOTACILLIN-N
Drug patent expirations by year for TOTACILLIN-N

US Patents and Regulatory Information for TOTACILLIN-N

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 060677-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 060677-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 062727-002 Dec 19, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 060677-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 062727-001 Dec 19, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 060677-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 060677-001 Approved Prior to Jan 1, 1982 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

TOTACILLIN-N Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Penicillin Drugs: A Case Study of Penicillin Derivatives like Totacillin-N

Introduction

Penicillin, one of the earliest and most widely used antibiotic classes, continues to play a crucial role in the treatment of various bacterial infections. This article delves into the market dynamics and financial trajectory of penicillin drugs, using Totacillin-N, a penicillin derivative, as a case study.

Global Antibiotics Market Overview

The global antibiotics market is projected to grow significantly over the coming years. As of 2023, the market size was valued at USD 51.19 billion and is expected to reach around USD 85.80 billion by 2033, growing at a CAGR of 5.3%[3].

Penicillin Drug Market Size and Growth

The penicillin segment, in particular, accounted for the largest revenue share of 23.8% in 2023. The penicillin drug market is estimated to reach USD 10.71 billion in 2024 and is expected to grow to USD 12.55 billion by 2029, with a CAGR of 3.21% during the forecast period[1].

Impact of COVID-19 on the Penicillin Market

The COVID-19 pandemic had a mixed impact on the penicillin market. Initially, the pandemic disrupted production and supply chains, but subsequent research on penicillin derivatives as potential inhibitors of the SARS-CoV-2 main protease has opened new avenues for growth. For instance, studies have shown that β-lactams, including penicillin derivatives, have considerable potential as SARS-CoV-2 main protease inhibitors[1].

Regulatory and Financial Challenges

Developing new antibiotics, including penicillin derivatives, is fraught with regulatory and financial challenges. Companies face significant hurdles, including costly clinical trials and stringent regulatory requirements. For example, Basilea Pharmaceutica's experience with its antibiotic drug highlights the complexities and costs involved in bringing a new antibiotic to market. Large-scale clinical trials can cost hundreds of millions of dollars, and regulatory changes can necessitate additional trials, further increasing costs[2].

Financial Viability of Antibiotic Development

The financial viability of developing antibiotics is a major concern. Unlike drugs in other therapeutic areas, antibiotics need to be used judiciously to prevent resistance, which limits their sales potential. Median annual sales of antibiotics in their first market, usually the US, were just $16.2 million between 2010 and 2019. This makes it challenging for companies to generate significant revenue from antibiotic sales alone[2].

Market Segments and Growth Drivers

Penicillin Segment

Penicillin remains a cornerstone in the treatment of various infections, including those caused by staphylococci, streptococci, clostridium, and listeria. However, the segment is expected to lose market share due to antibiotic resistance and adverse effects[3].

Cephalosporin Segment

Cephalosporins, another subtype of β-lactam antibiotics, are anticipated to witness significant growth. These drugs are effective against both gram-positive and gram-negative bacteria and are used to treat resistant pathogens. The generics-dominated cephalosporin segment is expected to continue its seasonal usage patterns[3].

Application Insights

Penicillin and its derivatives are widely used in various applications, including:

  • Pharyngitis and Skin Infections: Penicillin is often the first line of treatment for these common infections.
  • Bronchial Cough and Gonorrhea: It is effective against a range of bacterial infections.
  • Ear Fungus: Penicillin derivatives are used to treat fungal infections in the ear[3].

Key Takeaways

  • The global antibiotics market, including penicillin, is expected to grow significantly over the next decade.
  • Penicillin derivatives like Totacillin-N face regulatory and financial challenges but remain crucial in treating bacterial infections.
  • The COVID-19 pandemic has highlighted new potential uses for penicillin derivatives.
  • Despite growth, the financial returns from antibiotic sales are generally lower compared to other therapeutic areas.

FAQs

Q: What is the projected market size for the penicillin drug market by 2029?

A: The penicillin drug market is expected to reach USD 12.55 billion by 2029[1].

Q: How has the COVID-19 pandemic impacted the penicillin market?

A: The pandemic initially disrupted production but later opened new research avenues for penicillin derivatives as potential SARS-CoV-2 main protease inhibitors[1].

Q: What are the main financial challenges in developing new antibiotics?

A: Developing new antibiotics involves costly clinical trials, stringent regulatory requirements, and limited sales potential due to the need for judicious use to prevent resistance[2].

Q: Which segment dominates the antibiotics market in terms of revenue share?

A: The penicillin segment accounted for the largest revenue share of 23.8% in 2023[3].

Q: What are some of the common applications of penicillin and its derivatives?

A: Penicillin is used to treat pharyngitis, skin infections, bronchial cough, gonorrhea, and ear fungus, among other infections[3].

Sources

  1. Mordor Intelligence: Penicillin Drug Market Report | Industry Analysis, Size & Forecast
  2. C&EN: New antibiotics are hard to come by. Red tape is making the problem worse.
  3. NovaOne Advisor: Antibiotics Market Size, Share & Growth Analysis Report 2033
  4. Custom Market Insights: Global Antibacterial Drugs Market Size Reach $67.9 Bn 2032
  5. WHO: Antimicrobial resistance - World Health Organization (WHO)

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