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Last Updated: April 26, 2025

POLYCILLIN-N Drug Patent Profile


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Which patents cover Polycillin-n, and when can generic versions of Polycillin-n launch?

Polycillin-n is a drug marketed by Bristol and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Polycillin-n

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

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Summary for POLYCILLIN-N
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 76
DailyMed Link:POLYCILLIN-N at DailyMed
Drug patent expirations by year for POLYCILLIN-N

US Patents and Regulatory Information for POLYCILLIN-N

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bristol POLYCILLIN-N ampicillin sodium INJECTABLE;INJECTION 050309-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol POLYCILLIN-N ampicillin sodium INJECTABLE;INJECTION 050309-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol POLYCILLIN-N ampicillin sodium INJECTABLE;INJECTION 050309-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol POLYCILLIN-N ampicillin sodium INJECTABLE;INJECTION 050309-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol POLYCILLIN-N ampicillin sodium INJECTABLE;INJECTION 050309-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Market Dynamics and Financial Trajectory of the Penicillin Drug Market

Introduction to Penicillin Drugs

Penicillin drugs, including those like POLYCILLIN-N, are a cornerstone in the treatment of bacterial infections. These antibiotics, derived from the fungi of the Penicillium genus, have been pivotal in modern medicine since their discovery.

Market Size and Growth Projections

The global penicillin drug market is anticipated to experience steady growth over the coming years. Here are some key projections:

  • Current Market Size: The market size is estimated to be around USD 9.6 billion in 2024[1][3][4].
  • Forecasted Growth: The market is expected to grow to USD 13.4 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 3.8% from 2024 to 2033[1].
  • Alternative Projections: Another forecast suggests the market will reach USD 12.55 billion by 2029, growing at a CAGR of 3.21% from 2024 to 2029[3].

Key Drivers of Market Growth

Several factors are driving the growth of the penicillin drug market:

Increasing Prevalence of Infectious Diseases

The rising incidence of infectious diseases such as pneumonia and syphilis is a significant driver. As the global population grows, especially in regions with limited healthcare infrastructure, the demand for effective antibiotics like penicillin increases[3][4].

Demand for Generic and Affordable Medications

The surge in demand for generic and affordable penicillin medications is another key factor. Generic penicillins offer a cost-effective alternative to brand-name drugs, making them more accessible to a broader population[4].

Advancements in Drug Formulation and Delivery

Innovations in drug formulation, manufacturing, and delivery systems enhance the accessibility and convenience of penicillin drugs. This includes controlled-release formulations and novel drug delivery devices, which can improve patient compliance and outcomes[1].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the market. While it disrupted production and supply chains initially, it also led to increased self-medication with antimicrobials, including penicillin, which temporarily boosted demand[3][4].

Segmentation of the Penicillin Drug Market

The market is segmented based on several criteria:

By Source

Natural penicillin dominates the market due to its historical prominence, safety, and compliance with regulations. However, semisynthetic penicillins are also significant due to their broader spectrum of activity[1].

By Route of Administration

Oral administration is the leading route due to its convenience, patient preference, and cost-effectiveness. This segment enhances patient satisfaction and therapeutic outcomes[1].

By Spectrum of Activity

Broad-spectrum penicillins are preferred for their efficacy against a wide range of bacterial infections, simplifying treatment regimens and reducing healthcare costs[1][3].

By Distribution Channel

Hospitals dominate the distribution channel with a significant market share due to their dedicated pharmacies and specialized inpatient treatment capabilities[1].

Regional Analysis

North America

North America is projected to maintain a dominant position in the global penicillin drug market, with a market share of around 38.2% in 2024. This is due to the region's well-developed healthcare infrastructure, robust pharmaceutical industry, and informed population[1].

Asia-Pacific

The Asia-Pacific region is expected to experience the fastest growth during the forecast period. This growth is driven by the increasing burden of infectious diseases and growing investments in R&D for penicillin medications in countries like China and India[3][4].

Competitive Landscape

The penicillin drug market features several key players, including Pfizer, Inc., Novartis AG, and Lupin Limited. These companies are actively engaged in research and development to address emerging bacterial resistance and enhance antibiotic efficacy[3].

Latest Trends and Innovations

Customized Medicinal Drugs

There is a trend towards customized medicinal drugs tailored to individual patients based on their genetic makeup and other factors. This approach is expected to improve the effectiveness of penicillin formulations and dosing regimens[1].

Continuous Manufacturing Processes

The adoption of continuous manufacturing processes offers advantages such as advanced performance, reduced production costs, and better quality control. This trend is expected to enhance the efficiency and quality of penicillin production[1].

Integration of Digital Health Technology

The integration of digital health technologies, including telemedicine platforms, is streamlining patient care and medication management. This can improve adherence to penicillin treatment regimens and overall patient outcomes[1].

Financial Trajectory

The financial trajectory of the penicillin drug market is positive, driven by the increasing demand for antibiotics and advancements in drug technology.

  • Revenue Growth: The market is expected to grow from USD 9.6 billion in 2024 to USD 13.4 billion by 2033, indicating a steady revenue increase[1].
  • Investments and Funding: Pharmaceutical companies are increasing their investments in R&D and manufacturing capacity, which is expected to bolster the market's financial performance. For example, investments by companies like Sandoz to enhance European production of penicillin compounds are significant[3].

Challenges and Opportunities

Antimicrobial Resistance

One of the major challenges facing the penicillin drug market is the increasing prevalence of antimicrobial resistance. This necessitates continuous research and development to create new and effective antibiotics[3][4].

Regulatory Compliance

Ensuring compliance with regulatory standards is crucial for market growth. Pharmaceutical companies must adhere to strict guidelines to maintain the safety and efficacy of their products[1].

Market Expansion

The growing demand for penicillin in emerging markets presents significant opportunities for market expansion. Collaborations with local distributors and healthcare providers can enhance market access and penetration[1].

Key Takeaways

  • The global penicillin drug market is expected to grow significantly, driven by increasing infectious disease prevalence and demand for effective antibiotics.
  • Natural and broad-spectrum penicillins are key segments, with oral administration being the preferred route.
  • North America and Asia-Pacific are critical regions, with North America dominating due to its robust healthcare infrastructure.
  • The market is driven by advancements in drug formulation, digital health technologies, and increasing investments in R&D.
  • Challenges include antimicrobial resistance and regulatory compliance, but opportunities for market expansion are substantial.

Frequently Asked Questions (FAQs)

What is the current size of the global penicillin drug market?

The global penicillin drug market size is estimated to be around USD 9.6 billion in 2024[1].

What is the forecasted growth rate of the penicillin drug market?

The market is expected to grow at a CAGR of 3.8% from 2024 to 2033[1].

Which region dominates the penicillin drug market?

North America dominates the global penicillin drug market, with a market share of around 38.2% in 2024[1].

What are the key drivers of the penicillin drug market?

Key drivers include the increasing prevalence of infectious diseases, demand for generic and affordable medications, and advancements in drug formulation and delivery systems[3][4].

How is the COVID-19 pandemic impacting the penicillin drug market?

The COVID-19 pandemic had a mixed impact, initially disrupting production but later increasing demand due to self-medication practices[3][4].

Cited Sources:

  1. Dimension Market Research: "Penicillin Drug Market Is Expected To Reach a Revenue Of USD 13.4 Bn By 2033 at 3.8% CAGR"[1].
  2. PolyPid Ltd.: "PolyPid Provides Corporate Update and Reports Second Quarter"[2].
  3. Mordor Intelligence: "Penicillin Drug Market Size (2024 - 2029)"[3].
  4. Allied Market Research: "Penicillin Drug Market Size, Share & Growth Report, 2032"[4].

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