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Last Updated: December 22, 2024

DORIPENEM - Generic Drug Details


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What are the generic drug sources for doripenem and what is the scope of patent protection?

Doripenem is the generic ingredient in one branded drug marketed by Shionogi Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for doripenem.

Drug Prices for DORIPENEM

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Recent Clinical Trials for DORIPENEM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Postgraduate Institute of Medical Education and ResearchPhase 3
Tan Tock Seng HospitalPhase 2/Phase 3
Changi General HospitalPhase 2/Phase 3

See all DORIPENEM clinical trials

Paragraph IV (Patent) Challenges for DORIPENEM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DORIBAX Injection doripenem 250 mg/vial and 500 mg/vial 022106 1 2011-10-12

US Patents and Regulatory Information for DORIPENEM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-002 Oct 5, 2010 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-001 Oct 12, 2007 DISCN Yes 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

Expired US Patents for DORIPENEM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-002 Oct 5, 2010 ⤷  Subscribe ⤷  Subscribe
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-001 Oct 12, 2007 ⤷  Subscribe ⤷  Subscribe
Shionogi Inc DORIBAX doripenem INJECTABLE;INTRAVENOUS 022106-001 Oct 12, 2007 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for DORIPENEM

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International NV Doribax doripenem EMEA/H/C/000891
Doribax is indicated for the treatment of the following infections in adults:nosocomial pneumonia (including ventilator-associated pneumonia);complicated intra-abdominal infections;complicated urinary tract infections.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Withdrawn no no no 2008-07-25
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

DORIPENEM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Doripenem

Introduction to Doripenem

Doripenem is a broad-spectrum carbapenem antibiotic, widely used for treating severe bacterial infections, particularly in hospitalized patients. Its efficacy against multi-drug resistant bacteria has made it a crucial component in modern antibiotic therapy.

Market Growth Drivers

Increasing Antibiotic Resistance

The rising incidence of multi-drug resistant infections is a significant driver for the Doripenem market. As bacteria become increasingly resistant to traditional antibiotics, the demand for effective treatments like Doripenem surges[2][5].

Growing Demand in Hospital Settings

Hospitals and healthcare facilities are the primary consumers of Doripenem, driven by the need for effective antimicrobial therapies to combat severe bacterial infections. This demand is further fueled by increasing hospital admissions and the prevalence of healthcare-associated infections[2][5].

Advancements in Healthcare Infrastructure

Investments in healthcare infrastructure, especially in emerging markets like the Asia-Pacific region, are expanding access to antibiotics and driving market growth. Countries such as India and China are experiencing rapid growth due to these investments[2][5].

Regulatory and Policy Support

Policy mandates for antibiotic stewardship and the focus on combating resistant bacteria by healthcare systems, such as the National Health Service in the U.K., also propel the demand for Doripenem[2][5].

Regional Market Analysis

North America

The United States leads the Doripenem market, driven by high healthcare expenditures and a robust demand for effective treatments against multi-drug resistant pathogens. The market size in the U.S. is estimated to reach approximately $200 million by 2025, with a CAGR of around 4.5%[2].

Europe

Countries like Germany and France have stringent regulatory environments and advanced healthcare systems, which bolster the demand for Doripenem. The U.K. market, valued around $35 million, is expected to grow by 4% annually[2].

Asia-Pacific

The Asia-Pacific region, particularly India and China, shows rapid growth due to expanding healthcare infrastructure and rising awareness of antibiotic treatments. China's Doripenem market is projected to reach $80 million by 2025, growing at a 6% CAGR[2].

Latin America and Middle East

Brazil and Mexico in Latin America, and Saudi Arabia and the UAE in the Middle East, are key markets driven by improving economic conditions and increasing healthcare investments[5].

Financial Trajectory

Market Size and Growth Rate

The Doripenem market is projected to exhibit a robust CAGR of 5.20% during the forecast period from 2024 to 2031. This growth reflects the increasing need for effective treatment options in combating antibiotic resistance[2][5].

Revenue Projections

The global market for Doripenem is valued at approximately several hundred million dollars, with significant growth anticipated. For instance, the Chinese market alone is projected to reach $80 million by 2025[2].

Key Players and Market Share

Major players in the Doripenem market include Merck & Co., Pfizer, and other regional players. Merck & Co. dominates the market in several regions, including the U.S., Canada, and Italy. The competitive landscape is characterized by strategic collaborations and aggressive pricing strategies[2][5].

Challenges and Restraints

Regulatory Hurdles

Stringent regulatory processes for antibiotic approvals and growing concerns over antibiotic stewardship practices can limit prescription rates and hinder market growth[5].

Generic Alternatives

The emergence of generic alternatives puts pressure on the profit margins of branded Doripenem, posing a significant challenge to market dynamics[5].

Antibiotic Resistance

The rise in antibiotic-resistant bacterial strains and the tedious process of developing new carbapenem-based antibiotics also hamper market growth[3].

Emerging Opportunities

Combination Therapies

The potential development of combination therapies that enhance the efficacy of Doripenem presents avenues for growth in new therapeutic contexts. Ongoing research into the drug's application in treating resistant infections is another area of opportunity[5].

Global Initiatives

Global initiatives aimed at addressing antibiotic resistance could bolster the market position of Doripenem. Collaborations with healthcare providers to ensure appropriate prescribing practices are also crucial for maintaining market relevance and driving sustainable growth[5].

Expanding Applications

There is a growing trend towards expanding the application of Doripenem in outpatient settings and increasing awareness of antibiotic resistance, which could further fuel market growth[2].

Competitive Landscape

The Doripenem market is highly competitive, with key players focusing on research and development to enhance the efficacy of the drug and expand its applications. Strategic collaborations and partnerships aimed at improving distribution channels and market reach are common. The recent FDA approval of advanced formulations has intensified competition, highlighting the importance of regulatory advancements in shaping market trajectories[5].

Key Takeaways

  • Growing Demand: The Doripenem market is driven by the increasing incidence of multi-drug resistant infections and the growing demand for effective antimicrobial therapies.
  • Regional Growth: North America, particularly the U.S., leads the market, while emerging markets in the Asia-Pacific region show significant growth potential.
  • Financial Projections: The market is projected to exhibit a CAGR of 5.20% during the forecast period, reaching significant revenue milestones.
  • Challenges: Regulatory hurdles, generic alternatives, and antibiotic resistance pose challenges to market growth.
  • Emerging Opportunities: Combination therapies, global initiatives, and expanding applications present opportunities for growth.

FAQs

What is Doripenem used for?

Doripenem is a broad-spectrum carbapenem antibiotic used for treating severe bacterial infections, particularly in hospitalized patients.

Which regions are driving the growth of the Doripenem market?

North America, especially the United States, and the Asia-Pacific region, particularly India and China, are driving the growth of the Doripenem market.

What are the key challenges facing the Doripenem market?

The key challenges include stringent regulatory processes, the emergence of generic alternatives, and the rise in antibiotic-resistant bacterial strains.

Who are the major players in the Doripenem market?

Major players include Merck & Co., Pfizer, and other regional players.

What are the emerging opportunities in the Doripenem market?

Emerging opportunities include the development of combination therapies, global initiatives to address antibiotic resistance, and expanding the drug's application in outpatient settings.

Sources

  1. Market Research Intellect: "The Future of Antibiotic Therapy: Doripenem Leads the Charge"
  2. OpenPR: "Comprehensive Market Forecast for Doripenem: Market Analysis"
  3. Fact.MR: "Carbapenem-based Antibiotics Market to Garner US$ 1.8 billion by 2031"
  4. OpenPR: "Doripenem Market Overview: Segmentation Analysis, Growth"
  5. OpenPR: "Doripenem Market Growth, Segmentation, and Forecast Analysis"

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