Ceftolozane sulfate; tazobactam sodium - Generic Drug Details

What are the generic sources for ceftolozane sulfate; tazobactam sodium and what is the scope of patent protection?

Ceftolozane sulfate; tazobactam sodium is the generic ingredient in one branded drug marketed by Cubist Pharms Llc and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ceftolozane sulfate; tazobactam sodium has one hundred and one patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for ceftolozane sulfate; tazobactam sodium

International Patents:	101
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	ceftolozane sulfate; tazobactam sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ceftolozane sulfate; tazobactam sodium

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.

Pharmacology for ceftolozane sulfate; tazobactam sodium

Drug Class	Cephalosporin Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ceftolozane sulfate; tazobactam 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 ceftolozane sulfate; tazobactam sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes			Y
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes				Y

International Patents for ceftolozane sulfate; tazobactam sodium

Country	Patent Number	Title	Estimated Expiration
Canada	2906151	COMPOSITIONS ANTIBIOTIQUES DE CEFTOLOZANE (CEFTOLOZANE ANTIBIOTIC COMPOSITIONS)
China	1708502	Cephem compounds
Eurasian Patent Organization	029090	АНТИБАКТЕРИАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЦЕФТОЛОЗАН И ТАЗОБАКТАМ, И КОНТЕЙНЕР С ДОЗИРОВАННОЙ ЛЕКАРСТВЕННОЙ ФОРМОЙ, СОДЕРЖАЩЕЙ КОМПОЗИЦИИ (ANTIBACTERIAL PHARMACEUTICAL COMPOSITIONS COMPRISING CEFTOLOZANE AND TAZOBACTAM, AND UNIT DOSAGE FORM CONTAINER COMPRISING THE COMPOSITIONS)
Austria	368042
Hong Kong	1086566	Cephem compounds
Japan	7177314
Argentina	041729	COMPUESTO DE CEFEMO

Supplementary Protection Certificates for ceftolozane sulfate; tazobactam sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1556389	1690003-7	Sweden		PRODUCT NAME: CEFTOLOZAN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, SPECIELLT ETT SVAVELSYRASALT; REG. NO/DATE: EU/1/15/1032 20150918
1556389	122015000113	Germany		PRODUCT NAME: CEFTOLOZAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, INSBESONDERE EIN SCHWEFELSAEURESALZ; REGISTRATION NO/DATE: EU/1/15/1032/001 20150918
1556389	300793	Netherlands		PRODUCT NAME: CEFTOLOZAAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN IN HET BIJZONDER EEN ZWAVELZUURZOUT; REGISTRATION NO/DATE: EU/1/15/1032 20150922
1556389	C01556389/01	Switzerland		PRODUCT NAME: CEFTOLOZAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65472 03.03.2016
1556389	16C0004	France		PRODUCT NAME: CEFTOLOZANE,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,PLUS PARTICULIEREMENT UN SEL D'ACIDE SULFURIQUE; REGISTRATION NO/DATE: EU/1/15/1032 20150922
1556389	CR 2016 00004	Denmark		PRODUCT NAME: CEFTOLOZAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT ET SVOVLSYRESALT; REG. NO/DATE: EU/1/15/1032/001 20150922
1556389	92943	Luxembourg		PRODUCT NAME: CEFTOLOZANE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER UN SEL D'ACIDE SULFURIQUE (ZERBAXA); FIRST REGISTRATION: 20150922

Market Dynamics and Financial Trajectory of Ceftolozane Sulfate and Tazobactam Sodium (ZERBAXA)

Introduction

Ceftolozane sulfate and tazobactam sodium, marketed under the brand name ZERBAXA, is a potent antibiotic combination that has significantly impacted the treatment of complicated infections. This article delves into the market dynamics and financial trajectory of ZERBAXA, highlighting its clinical significance, regulatory approvals, and market performance.

Clinical Significance of ZERBAXA

ZERBAXA is a fixed-dose combination of ceftolozane, a cephalosporin antibiotic, and tazobactam, a β-lactamase inhibitor. This combination extends the antimicrobial spectrum of ceftolozane to include β-lactamase-producing bacteria, which are often resistant to other antibiotics[2].

Treatment Indications

ZERBAXA is approved for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, and complicated intra-abdominal infections (cIAIs) in combination with metronidazole. It has also been approved for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)[3].

Regulatory Approvals

The regulatory journey of ZERBAXA has been pivotal in its market success.

FDA Approvals

ZERBAXA received its initial FDA approval in 2014 for cUTIs and cIAIs. In 2019, the FDA approved a supplemental New Drug Application (sNDA) for the treatment of HABP/VABP, expanding its indications[3].

International Approvals

In addition to FDA approvals, ZERBAXA has been approved by other regulatory bodies such as the Therapeutic Goods Administration (TGA) in Australia, further broadening its global reach[2].

Market Dynamics

Competitive Landscape

The antibiotic market is highly competitive, with several established and new entrants. However, ZERBAXA's unique mechanism of action and broad spectrum of activity against Gram-negative bacteria, including those producing β-lactamases, set it apart from other antibiotics[2].

Market Demand

The increasing prevalence of antibiotic-resistant infections has driven the demand for effective and innovative antibiotics like ZERBAXA. The global market for antibiotics is expected to grow significantly, driven by the need for treatments that can combat resistant bacterial infections[4].

Financial Trajectory

Acquisition and Integration

Merck acquired ZERBAXA as part of its purchase of Cubist Pharmaceuticals, Inc. This acquisition was a strategic move to strengthen Merck's antibiotic portfolio and has contributed significantly to its financial performance[1].

Revenue Growth

Since its approval, ZERBAXA has shown steady revenue growth. The expansion of its indications to include HABP/VABP has further boosted its sales. Merck's financial reports reflect the increasing revenue from ZERBAXA, contributing to the company's overall financial health.

Cost and Pricing

The cost of ZERBAXA is a critical factor in its market dynamics. Given its efficacy and the severity of the infections it treats, ZERBAXA is generally priced higher than some other antibiotics. However, its value proposition in terms of clinical outcomes and the reduction in healthcare costs associated with treating resistant infections justifies its pricing[2].

Clinical Trial Outcomes and Impact

Phase 3 Clinical Studies

The pivotal Phase 3 clinical studies published in The Lancet and Clinical Infectious Diseases demonstrated the efficacy of ZERBAXA in treating cUTIs and cIAIs. These studies showed that ZERBAXA was non-inferior to levofloxacin and other standard treatments, with a composite cure rate that met the primary endpoints[1].

Real-World Impact

In real-world settings, ZERBAXA has been shown to improve patient outcomes by effectively treating infections caused by resistant bacteria. This has led to reduced morbidity, mortality, and healthcare costs associated with prolonged hospital stays and additional treatments.

Expert Insights and Statistics

Expert Opinions

"Ceftolozane/tazobactam is a new treatment option for patients facing complicated urinary tract infections caused by certain susceptible Gram-negative bacteria," said Florian M. Wagenlehner, M.D., Ph.D., highlighting the clinical significance of ZERBAXA[1].

Statistical Evidence

In the clinical trials for HABP/VABP, approximately 13% of patients were failing their current antibacterial drug therapy, and bacteremia was present at baseline in 15% of patients. ZERBAXA demonstrated non-inferiority to meropenem in terms of 28-day all-cause mortality, with a weighted proportion difference of 1.1%[3].

Market Challenges and Opportunities

Antibiotic Resistance

One of the significant challenges facing ZERBAXA is the ongoing issue of antibiotic resistance. However, this also presents an opportunity for continued innovation and development of new antibiotics that can combat resistant bacteria.

Regulatory Environment

The regulatory environment is stringent, and any new antibiotic must undergo rigorous clinical trials to demonstrate safety and efficacy. This environment, while challenging, ensures that only effective and safe treatments reach the market.

Future Outlook

Expanding Indications

There is potential for ZERBAXA to be approved for additional indications, further expanding its market reach. Ongoing research and clinical trials will be crucial in this regard.

Global Expansion

As ZERBAXA gains more international approvals, its global market presence is expected to grow. This expansion will be driven by the increasing need for effective antibiotics worldwide.

Key Takeaways

• Clinical Significance: ZERBAXA is a potent antibiotic combination effective against complicated infections caused by resistant Gram-negative bacteria.
• Regulatory Approvals: ZERBAXA has received FDA and international approvals for various indications, including cUTIs, cIAIs, and HABP/VABP.
• Market Dynamics: The antibiotic market is competitive, but ZERBAXA's unique mechanism and broad spectrum of activity set it apart.
• Financial Trajectory: ZERBAXA has shown steady revenue growth since its approval, contributing to Merck's financial health.
• Future Outlook: There is potential for expanding indications and global market expansion.

FAQs

Q: What are the primary indications for ZERBAXA?

A: ZERBAXA is approved for the treatment of complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)[3].

Q: How does ZERBAXA differ from other antibiotics?

A: ZERBAXA combines ceftolozane, a cephalosporin antibiotic, with tazobactam, a β-lactamase inhibitor, extending its spectrum to include β-lactamase-producing bacteria[2].

Q: What are the key findings from the Phase 3 clinical studies of ZERBAXA?

A: The Phase 3 studies showed that ZERBAXA was non-inferior to levofloxacin and other standard treatments, with a composite cure rate that met the primary endpoints[1].

Q: How has ZERBAXA impacted patient outcomes?

A: ZERBAXA has improved patient outcomes by effectively treating infections caused by resistant bacteria, reducing morbidity, mortality, and healthcare costs[3].

Q: What are the future prospects for ZERBAXA in the market?

A: ZERBAXA has potential for expanding indications and global market expansion, driven by the increasing need for effective antibiotics worldwide.

Sources

1. Merck Announces Publication of Pivotal Data from Phase 3 Clinical Studies of ZERBAXA™ (Ceftolozane/Tazobactam) in The Lancet and Clinical Infectious Diseases. Merck.
2. Zerbaxa Sponsor - Therapeutic Goods Administration (TGA). Therapeutic Goods Administration.
3. FDA Approves Merck's ZERBAXA® (ceftolozane and tazobactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP). Merck.
4. Ceftolozane with tazobactam for treating hospital-acquired pneumonia. NICE.