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Last Updated: December 22, 2024

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AMPICILLIN TRIHYDRATE Drug Patent Profile


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Which patents cover Ampicillin Trihydrate, and when can generic versions of Ampicillin Trihydrate launch?

Ampicillin Trihydrate is a drug marketed by Aurobindo Pharma, Belcher Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Lederle, Mylan, Purepac Pharm, Sandoz, Strides Pharma, Vitarine, Endo Operations, and Teva. and is included in sixteen NDAs.

The generic ingredient in AMPICILLIN TRIHYDRATE is ampicillin/ampicillin trihydrate. Three suppliers are listed for this compound. Additional details are available on the ampicillin/ampicillin trihydrate profile page.

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Drug patent expirations by year for AMPICILLIN TRIHYDRATE
Recent Clinical Trials for AMPICILLIN TRIHYDRATE

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SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

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Pharmacology for AMPICILLIN TRIHYDRATE

US Patents and Regulatory Information for AMPICILLIN TRIHYDRATE

AMPICILLIN TRIHYDRATE is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purepac Pharm AMPICILLIN TRIHYDRATE ampicillin/ampicillin trihydrate FOR SUSPENSION;ORAL 061980-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva AMPICILLIN TRIHYDRATE ampicillin/ampicillin trihydrate FOR SUSPENSION;ORAL 061370-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma AMPICILLIN TRIHYDRATE ampicillin/ampicillin trihydrate CAPSULE;ORAL 216554-001 Oct 31, 2023 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma AMPICILLIN TRIHYDRATE ampicillin/ampicillin trihydrate CAPSULE;ORAL 062882-001 Feb 25, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Endo Operations AMPICILLIN TRIHYDRATE ampicillin/ampicillin trihydrate FOR SUSPENSION;ORAL 062982-002 Feb 10, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Sub Teva Pharms AMPICILLIN TRIHYDRATE ampicillin/ampicillin trihydrate CAPSULE;ORAL 060765-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Belcher Pharms AMPICILLIN TRIHYDRATE ampicillin/ampicillin trihydrate CAPSULE;ORAL 061602-002 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

AMPICILLIN TRIHYDRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ampicillin Trihydrate

Market Overview

Ampicillin trihydrate, a broad-spectrum antibiotic belonging to the penicillin group, is poised for significant growth in the coming years. The global Ampicillin market is expected to reach USD 388.1 million by 2024 and further expand to USD 480.1 million by 2033, with a projected CAGR of 2.4% during the forecast period from 2024 to 2033[3].

Growth Drivers

Several factors are driving the growth of the Ampicillin market:

Increasing Incidence of Infectious Diseases

The rising incidence of infectious diseases, particularly respiratory, urinary, meningoencephalitis, and gastrointestinal infections, is a key driver. Ampicillin's effectiveness against both gram-positive and gram-negative microorganisms makes it a preferred treatment option[3].

Population Growth and Urbanization

Population growth and urbanization in developing nations contribute to higher bacterial infection rates, thereby increasing the demand for Ampicillin. Urbanization often leads to overcrowding and poor sanitation, which can exacerbate the spread of bacterial infections[3].

Regulatory Oversight

Regulatory bodies such as the WHO and CDC play a crucial role in influencing market growth by setting standards and guidelines for antibiotic usage. This oversight ensures that Ampicillin and other antibiotics are used responsibly to combat antibiotic resistance[3].

Market Segmentation

The Ampicillin market can be segmented in several ways:

By Type

Ampicillin sodium for injection is expected to dominate the market due to its instantaneous action when administered intravenously. This form of Ampicillin is particularly effective in treating severe infections[3].

By Mode of Administration

Oral administration is projected to dominate the market, capturing 63.7% of the market space by 2024. This is due to the convenience and non-invasiveness of oral administration[3].

By Disease Indication

Infections such as gonorrhea, pneumonia, meningitis, and salmonella infections drive the demand for Ampicillin. Its broad-spectrum antibacterial action makes it effective against a range of bacterial infections[1][3].

By Distribution Channel

Hospital pharmacies are anticipated to lead with a 64.9% market share. This is because hospitals are primary treatment centers for severe bacterial infections, and Ampicillin is often administered in these settings[3].

Regional Analysis

The global Ampicillin market is geographically diverse:

North America

North America is projected to command the market with a 37.2% share by the end of 2024. This is driven by the well-developed healthcare infrastructure and the presence of many research organizations in the region[3].

Europe, Asia Pacific, Latin America, and Middle East & Africa

These regions also represent significant markets for Ampicillin, with growth driven by increasing healthcare spending, more healthcare facilities, and greater awareness of infectious diseases[3].

Financial Trajectory

The financial outlook for the Ampicillin market is promising:

Market Size and Growth

The market is expected to grow from USD 388.1 million in 2024 to USD 480.1 million by 2033, representing a growth of USD 92.0 million over the forecast period[3].

Price Trends

Ampicillin prices are expected to remain relatively stable with minimal fluctuations. However, there has been an upward trend in prices due to high demand, especially during the cold winter months when respiratory infections are more prevalent[2].

Cost and Pricing Analysis

The cost of raw materials, particularly penicillin, has seen significant increases, affecting the production costs of Ampicillin. Despite this, the prices of Ampicillin have been managed by strict regulations, ensuring affordability and availability[2].

Competitive Landscape

The Ampicillin market is highly competitive, with several major pharmaceutical companies involved:

Key Players

Companies such as Pfizer Inc., GlaxoSmithKline plc, Teva Pharmaceutical Industries Ltd., Novartis International AG, Aurobindo Pharma Limited, and others are prominent players in the market. These companies invest heavily in research and development to maintain their market position[3].

Challenges and Restraints

Despite the positive growth outlook, the Ampicillin market faces several challenges:

Antibiotic Resistance

The rise of antibiotic-resistant bacterial strains is a significant threat. This necessitates the development of new antibiotics, increasing R&D costs and posing a major challenge to the market[3].

Regulatory Approvals

Stringent regulatory approvals and compliance requirements can delay the market entry of new Ampicillin formulations, impeding market growth[3].

Growth Opportunities

There are several opportunities for growth in the Ampicillin market:

Emerging Markets

Regions like Asia-Pacific and Latin America present significant growth opportunities due to increased healthcare spending, more healthcare facilities, and greater awareness of infectious diseases[3].

Collaborations and Partnerships

Collaborations between pharmaceutical companies and research institutions can foster innovation and market expansion. International collaborations for accurate antibiotic resistance testing and investments in production facilities are examples of such opportunities[3].

Recent Developments

Several recent developments highlight the dynamic nature of the Ampicillin market:

International Collaborations

International collaborations for accurate antibiotic resistance testing and the WHO's call for pharmaceutical companies to prioritize antibiotic development for newborns are significant recent developments[3].

FDA Approvals and Production Investments

The FDA approval of Xacduro for treating hospital-acquired and ventilator-associated bacterial pneumonia and Sandoz's investment in an Austrian facility to boost penicillin production are notable recent developments[3].

Key Takeaways

  • The global Ampicillin market is projected to grow significantly, driven by increasing infectious disease incidence and regulatory oversight.
  • Oral administration and hospital pharmacies are expected to dominate the market.
  • North America will lead the market, but emerging regions like Asia-Pacific and Latin America offer significant growth opportunities.
  • The market faces challenges from antibiotic resistance and stringent regulatory approvals.
  • Collaborations and investments in research and production are key to market expansion.

FAQs

Q: What is the projected market size of Ampicillin by 2033? A: The global Ampicillin market is expected to reach USD 480.1 million by 2033[3].

Q: What are the primary drivers of the Ampicillin market growth? A: The primary drivers include the increasing incidence of infectious diseases, population growth, urbanization, and regulatory oversight[3].

Q: Which region is expected to dominate the Ampicillin market? A: North America is projected to command the market with a 37.2% share by the end of 2024[3].

Q: What are the main challenges facing the Ampicillin market? A: The main challenges include antibiotic resistance and stringent regulatory approvals[3].

Q: How are Ampicillin prices expected to trend in the coming quarters? A: Ampicillin prices are expected to remain relatively stable with minimal fluctuations, but there may be a slight upward trend due to high demand[2].

Cited Sources

  1. IndustryARC: Ampicillin Market Size Report, 2024-2030[1]
  2. Procurement Resource: Ampicillin Price Trend, Index, News, Chart, Database[2]
  3. GlobeNewswire: Ampicillin Market Is Expected To Reach A Revenue Of USD 480.1 Mn By 2033 At 2.4% CAGR[3]

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