Meropenem - Generic Drug Details

What are the generic sources for meropenem and what is the scope of freedom to operate?

Meropenem is the generic ingredient in four branded drugs marketed by Acs Dobfar, Acs Dobfar Spa, Amneal Pharms, Brooks Steriscience, Daewoong Pharm Co, Eugia Pharma, Gland, Hospira Inc, Hq Spclt Pharma, Qilu, Sandoz, Savior Lifetec Corp, Pfizer, B Braun Medical Inc, and Rempex, and is included in sixteen NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for meropenem. Fifteen suppliers are listed for this compound.

Summary for meropenem

US Patents:	7
Tradenames:	4
Applicants:	15
NDAs:	16
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	137
Patent Applications:	6,548
Drug Prices:	Drug price trends for meropenem
What excipients (inactive ingredients) are in meropenem?	meropenem excipients list
DailyMed Link:	meropenem at DailyMed

See drug prices for meropenem

Recent Clinical Trials for meropenem

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

Sponsor	Phase
Scandinavian Critical Care Trials Group	Phase 4
Rutgers Robert Wood Johnson Medical School	Phase 4
Assaf-Harofeh Medical Center	Phase 4

See all meropenem clinical trials

Pharmacology for meropenem

Drug Class

Penem Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for meropenem

J01DH	Carbapenems
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for meropenem

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira Inc	MEROPENEM	meropenem	INJECTABLE;INJECTION	090940-002	Jun 22, 2010		DISCN	No	No
Gland	MEROPENEM	meropenem	INJECTABLE;INJECTION	206141-001	Jun 8, 2016	AP	RX	No	No
Acs Dobfar Spa	MEROPENEM	meropenem	INJECTABLE;INJECTION	204139-001	Jun 9, 2016	AP	RX	No	No
Sandoz	MEROPENEM	meropenem	INJECTABLE;INJECTION	091201-002	Mar 29, 2011		DISCN	No	No

Expired US Patents for meropenem

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	MERREM	meropenem	INJECTABLE;INJECTION	050706-001	Jun 21, 1996
Pfizer	MERREM	meropenem	INJECTABLE;INJECTION	050706-003	Jun 21, 1996

Meropenem Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Meropenem

Introduction to Meropenem

Meropenem, a broad-spectrum carbapenem antibiotic, is crucial in treating severe bacterial infections, including pneumonia, sepsis, meningitis, and complicated abdominal infections. The drug's market is experiencing significant growth due to several key factors.

Market Growth and Projections

The Meropenem injection market has shown a swift and substantial surge in recent years, with forecasts indicating continued significant expansion from 2023 to 2031. This growth is driven by the increasing global threat of antibiotic-resistant infections and the need for more potent antibiotics[1][5].

• Global Market Size: The global Meropenem API market size is estimated to grow at a compound annual growth rate (CAGR) of 4.00% from 2024 to 2031. North America dominates the market, accounting for around 40% of the global revenue, followed by the Asia Pacific region with a significant share[3].
• Regional Growth: The Asia Pacific region is witnessing a surge in Meropenem API sales, driven by the escalation of antibiotic resistance, expansion of healthcare consciousness, and the availability of generic versions. Latin America and the Middle East and Africa also show growth, albeit at a slower CAGR[3].

Drivers of Market Growth

Several factors are driving the growth of the Meropenem market:

• Antibiotic Resistance: The rise in antibiotic-resistant infections is a major driver. Meropenem remains effective against many resistant strains, making it a critical tool in healthcare[5].
• Healthcare Infrastructure: Increased investments in healthcare infrastructure, especially in emerging markets, are making Meropenem more accessible to a broader population[5].
• Government Funding: Governments worldwide are allocating more funds to combat infectious diseases, particularly in light of the COVID-19 pandemic and the growing threat of antimicrobial resistance[5].
• Strategic Collaborations: Partnerships and collaborations within the pharmaceutical industry are expanding the availability and accessibility of Meropenem[5].

Economic Benefits and Cost Considerations

The economic benefits of Meropenem are significant, despite some cost-related challenges:

• Pharmacodynamic Dosage Strategies: Studies have shown that pharmacodynamically influenced dosage strategies for Meropenem can reduce drug costs without compromising efficacy. For example, a lower dosage regimen can save $38.64 per day compared to standard regimens[2].
• Cost of Production: The complex manufacturing process and the need for sterile formulations make Meropenem relatively expensive compared to other antibiotics. However, its effectiveness in critical care scenarios justifies the cost[5].
• Regulatory Hurdles: Regulatory approval and pricing controls can delay the entry of Meropenem into new markets, but these hurdles are expected to decrease over time as global efforts to combat antibiotic resistance intensify[5].

Financial Trajectory

The financial trajectory of the Meropenem market is promising:

• Revenue Growth: The market is expected to see significant revenue growth, driven by the increasing demand for effective antibiotics. The global Meropenem API market size is projected to expand at a CAGR of 4.00% from 2024 to 2031[3].
• Investment Opportunities: The market presents lucrative investment opportunities for both established pharmaceutical companies and emerging biotechs. Investors can benefit from the growing demand for Meropenem, new drug formulations, and strategic collaborations[5].
• Market Penetration: Despite regulatory hurdles, the global push for antibiotic resistance solutions is expected to increase market penetration over time. Strategic collaborations and mergers within the pharmaceutical industry are instrumental in this expansion[5].

Key Trends and Challenges

• Advancements in Drug Formulations: Innovations in drug formulations and delivery methods are enhancing the effectiveness and accessibility of Meropenem[5].
• High Production Costs: The high cost of production remains a significant challenge, although the drug's effectiveness justifies these costs in critical care scenarios[5].
• Regulatory Challenges: Navigating regulatory approval processes in different countries can slow down market penetration, but these challenges are expected to decrease as global health priorities align[5].

Regional Market Dynamics

• North America: Dominates the market with over 40% of global revenue, driven by the high incidence of healthcare-associated infections (HAIs) and the elderly population's increased susceptibility to infections[3].
• Asia Pacific: Experiencing significant growth due to the escalation of antibiotic resistance, expansion of healthcare consciousness, and the availability of generic versions. Countries like China and India are key players due to their strong API production capabilities[3].
• Latin America and MEA: Showing growth, albeit at a slower CAGR, driven by the increasing awareness of antimicrobial resistance and the rising demand for broad-spectrum antibiotics[3].

Conclusion

The Meropenem market is poised for significant growth driven by the increasing global threat of antibiotic-resistant infections, investments in healthcare infrastructure, and strategic collaborations within the pharmaceutical industry. Despite challenges such as high production costs and regulatory hurdles, the drug's effectiveness and the global push for antibiotic resistance solutions ensure a robust financial trajectory.

Key Takeaways

• Growing Demand: Driven by antibiotic resistance and the need for potent antibiotics.
• Regional Growth: North America dominates, followed by the Asia Pacific region.
• Economic Benefits: Pharmacodynamic dosage strategies can reduce costs without compromising efficacy.
• Investment Opportunities: Lucrative opportunities in new drug formulations, strategic collaborations, and expanding healthcare markets.
• Challenges: High production costs and regulatory hurdles, though expected to decrease over time.

FAQs

1. What is driving the growth of the Meropenem market?

   • The rise in antibiotic-resistant infections, investments in healthcare infrastructure, and government funding to combat infectious diseases are key drivers.

2. How does the cost of Meropenem compare to other antibiotics?

   • Meropenem is relatively expensive due to its complex manufacturing process and the need for sterile formulations, but its effectiveness justifies the cost.

3. What are the main challenges in the Meropenem market?

   • High production costs and regulatory hurdles are significant challenges, although the global push for antibiotic resistance solutions is expected to mitigate these issues.

4. Which regions are experiencing the most growth in Meropenem sales?

   • North America and the Asia Pacific region are experiencing the most significant growth, driven by different factors such as HAIs in North America and antibiotic resistance in the Asia Pacific.

5. What investment opportunities exist in the Meropenem market?

   • Investors can benefit from the growing demand for Meropenem, new drug formulations, strategic collaborations, and expanding healthcare markets in emerging economies.

Sources

1. Market Research Intellect - Meropenem Injection Sales Market Size, Scope And Forecast Report
2. PubMed - Economic benefit of a meropenem dosage strategy based on pharmacodynamic concepts
3. Cognitive Market Research - Meropenem API Market Report 2024 (Global Edition)
4. ASPE - Antimicrobial Drugs Market Returns Analysis
5. Market Research Intellect - The Expanding Meropenem Injection Market: Addressing Global Health Threats with Advanced Antibiotic Solutions