Durlobactam sodium; durlobactam sodium; sulbactam sodium - Generic Drug Details

What are the generic sources for durlobactam sodium; durlobactam sodium; sulbactam sodium and what is the scope of freedom to operate?

Durlobactam sodium; durlobactam sodium; sulbactam sodium is the generic ingredient in one branded drug marketed by Entasis Therap and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Durlobactam sodium; durlobactam sodium; sulbactam sodium has seventy-eight patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for durlobactam sodium; durlobactam sodium; sulbactam sodium

International Patents:	78
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	durlobactam sodium; durlobactam sodium; sulbactam sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for durlobactam sodium; durlobactam sodium; sulbactam sodium

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for durlobactam sodium; durlobactam sodium; sulbactam sodium

J01CG	Beta-lactamase inhibitors
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for durlobactam sodium; durlobactam sodium; sulbactam sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	9,309,245			Y
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	10,376,499		Y
Entasis Therap	XACDURO (COPACKAGED)	durlobactam sodium; durlobactam sodium; sulbactam sodium	POWDER;INTRAVENOUS	216974-001	May 23, 2023		RX	Yes	Yes	9,623,014

International Patents for durlobactam sodium; durlobactam sodium; sulbactam sodium

Country	Patent Number	Title	Estimated Expiration
Spain	2717776
Mexico	2014011351	COMPUESTOS HETEROCICLICOS COMO INHIBIDORES DE BETA-LACTAMASAS. (HETEROBICYCLIC COMPOUNDS AS BETA-LACTAMASE INHIBITORS.)
Japan	6122484
Morocco	37383	Compose heterobicycliques comme inhibiteurs de la beta lactamase

Durlobactam sodium; durlobactam sodium; sulbactam sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Durlobactam Sodium and Sulbactam Sodium

Introduction

The combination of durlobactam and sulbactam, marketed as XACDURO, represents a significant advancement in the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), particularly against multidrug-resistant pathogens like Acinetobacter baumannii-calcoaceticus complex. Here, we delve into the market dynamics and financial trajectory of these antibiotics.

Market Need and Unmet Clinical Needs

The emergence of multidrug-resistant bacteria has created a critical need for new and effective antibiotics. Acinetobacter baumannii, in particular, poses a significant threat due to its resistance to many existing antibiotics, including carbapenems[4].

Regulatory Approval and Clinical Evidence

Durlobactam sodium, in combination with sulbactam, was approved by the FDA in May 2023 for the treatment of HABP/VABP caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. This approval was based on a single phase 3 non-inferiority trial comparing the combination to colistin, a drug with significant toxicity issues[3][4].

Efficacy and Safety Profile

Clinical trials have shown that the sulbactam-durlobactam combination is non-inferior to colistin in terms of 28-day all-cause mortality and has a more favorable safety profile. The combination demonstrated lower rates of acute kidney injury and other adverse events compared to colistin[3][4].

Market Competition

The antibiotic market is challenging due to the high development costs and the limited financial returns compared to other drug classes. Many large pharmaceutical companies have abandoned antibiotic research and development due to these financial constraints. However, small companies like Entasis Therapeutics have filled this gap, developing new antibiotics like the sulbactam-durlobactam combination[2].

Financial Challenges in Antibiotic Development

The financial landscape for antibiotic development is fraught with challenges. The high costs of bringing antibiotics to market, coupled with the limited volume of sales due to the need to reserve these drugs for last-resort use, make it difficult for companies to recoup their investments. This has led to innovative funding strategies, such as subscription models, to incentivize antibiotic development[2].

Innovative Funding Models

To address the financial gap, health economists and policymakers are exploring creative funding models. For example, the UK has implemented a pilot subscription model where the country invests in antibiotics that meet specific clinical needs and reimburses the companies regardless of the number of prescriptions sold. This model guarantees a predictable return on investment, encouraging further development[2].

Economic Prospects

Despite the regulatory approval and clinical success, the economic prospects for durlobactam and sulbactam are influenced by the broader challenges in the antibiotic market. The traditional volume-of-sales model does not provide sufficient returns to justify the investment in antibiotic R&D. Therefore, alternative funding models and policy changes are crucial for sustaining the development of new antibiotics[2].

Impact on Healthcare Costs

The introduction of effective antibiotics like durlobactam and sulbactam can significantly reduce healthcare costs associated with treating multidrug-resistant infections. By reducing the need for prolonged hospital stays, intensive care, and the use of more toxic drugs like colistin, these antibiotics can lower the overall cost of care[3][4].

Future Outlook

The future of durlobactam and sulbactam is tied to the evolving landscape of antibiotic resistance and the financial models that support their development. As resistance patterns continue to shift, the need for new and effective antibiotics will remain high. Innovative funding strategies and policy changes will be essential in ensuring that companies can continue to develop and bring these critical drugs to market[2].

Key Takeaways

• Regulatory Approval: Durlobactam and sulbactam were approved by the FDA in May 2023 for treating HABP/VABP caused by Acinetobacter baumannii-calcoaceticus complex.
• Clinical Evidence: The combination is non-inferior to colistin with a more favorable safety profile.
• Market Challenges: High development costs and limited financial returns are significant barriers.
• Innovative Funding: New funding models, such as subscription models, are being explored to incentivize antibiotic development.
• Economic Impact: Effective antibiotics can reduce healthcare costs associated with treating multidrug-resistant infections.

FAQs

1. What is the primary indication for the use of durlobactam and sulbactam?

   • The primary indication is for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex[1][3][4].

2. How was the FDA approval for durlobactam and sulbactam obtained?

   • The approval was based on a single phase 3 non-inferiority trial comparing the combination to colistin in patients with HABP/VABP[3][4].

3. What are the financial challenges in developing new antibiotics?

   • High development costs, limited volume of sales, and the need to reserve these drugs for last-resort use make it difficult for companies to recoup their investments[2].

4. What innovative funding models are being explored for antibiotic development?

   • Models such as subscription models, where countries invest in antibiotics and reimburse companies regardless of the number of prescriptions sold, are being explored[2].

5. How do durlobactam and sulbactam impact healthcare costs?

   • By reducing the need for prolonged hospital stays, intensive care, and the use of more toxic drugs like colistin, these antibiotics can lower the overall cost of care[3][4].

Sources

1. DrugBank Online - Durlobactam sodium.
2. Science - The past, present, and future of antibiotics.
3. VA Formulary Advisor - Sulbactam/durlobactam (XACDURO) Monograph.
4. FDA - Antimicrobial Drugs Advisory Committee Meeting.