ZERBAXA Drug Patent Profile

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

Zerbaxa is a drug marketed by Cubist Pharms Llc and is included in one NDA. There are fourteen patents protecting this drug.

This drug has one hundred and one patent family members in thirty-six countries.

The generic ingredient in ZERBAXA is ceftolozane sulfate; tazobactam sodium. One supplier is listed for this compound. Additional details are available on the ceftolozane sulfate; tazobactam sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Zerbaxa

Zerbaxa was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 14, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZERBAXA

International Patents:	101
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Drug Prices:	Drug price information for ZERBAXA
What excipients (inactive ingredients) are in ZERBAXA?	ZERBAXA excipients list
DailyMed Link:	ZERBAXA at DailyMed

See drug prices for ZERBAXA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZERBAXA

Constraining patent/regulatory exclusivity:

10,125,149

NDA:

206829

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.

Recent Clinical Trials for ZERBAXA

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

Sponsor	Phase
Hamad Medical Corporation	Phase 4
University Hospital, Toulouse	Phase 3
The University of Queensland	Phase 1/Phase 2

See all ZERBAXA clinical trials

Pharmacology for ZERBAXA

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

US Patents and Regulatory Information for ZERBAXA

ZERBAXA is protected by twenty-eight US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,125,149.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,320,740		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	7,129,232		Y	Y
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes	10,125,149		Y
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes	10,933,053

International Patents for ZERBAXA

When does loss-of-exclusivity occur for ZERBAXA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

European Patent Office

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZERBAXA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2906151	COMPOSITIONS ANTIBIOTIQUES DE CEFTOLOZANE (CEFTOLOZANE ANTIBIOTIC COMPOSITIONS)
Eurasian Patent Organization	201591712	АНТИБИОТИЧЕСКИЕ КОМПОЗИЦИИ НА ОСНОВЕ ЦЕФТОЛОЗАНА
New Zealand	718365	Solid forms of ceftolozane
World Intellectual Property Organization (WIPO)	2016025839
World Intellectual Property Organization (WIPO)	2014144295

Supplementary Protection Certificates for ZERBAXA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	1690003-7	Sweden		PRODUCT NAME: CEFTOLOZAN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, SPECIELLT ETT SVAVELSYRASALT; REG. NO/DATE: EU/1/15/1032 20150918
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	92943	Luxembourg		PRODUCT NAME: CEFTOLOZANE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER UN SEL D'ACIDE SULFURIQUE (ZERBAXA); FIRST REGISTRATION: 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

Market Dynamics and Financial Trajectory for ZERBAXA (Ceftolozane/Tazobactam)

Introduction

ZERBAXA, a combination antibiotic consisting of ceftolozane and tazobactam, has been a significant player in the treatment of complicated infections caused by Gram-negative bacteria. Here, we delve into the market dynamics and financial trajectory of this drug.

Clinical Significance and Indications

ZERBAXA is indicated for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) in adult patients. It has also shown promise in treating hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), with Phase 3 studies demonstrating non-inferiority to meropenem[4].

Market Approval and Publication

The pivotal Phase 3 clinical studies for ZERBAXA were published in prestigious journals such as The Lancet and Clinical Infectious Diseases, highlighting its efficacy in treating cUTI and cIAI. This publication reinforced ZERBAXA's position as a new treatment option for these infections[1].

Financial Performance

Acquisition and Initial Impact

Merck acquired ZERBAXA as part of its purchase of Cubist Pharmaceuticals, Inc. This acquisition was strategic, given the growing need for effective antibiotics against Gram-negative bacteria.

Sales and Revenue

In recent years, ZERBAXA has contributed significantly to Merck's revenue. Despite a temporary setback due to a product recall and suspension of sales in the fourth quarter of 2020, a phased resupply was initiated in the fourth quarter of 2021, which continued into 2022. This resupply helped in regaining market traction[2].

Quarterly and Annual Sales

In the third quarter of 2022, ZERBAXA benefited from the completion of its global resupply, contributing to robust global demand across key hospital products. This led to an increase in sales, reflecting the drug's importance in Merck's hospital segment[3].

Market Dynamics

Competitive Landscape

ZERBAXA competes in a crowded antibiotic market, but its efficacy against certain Gram-negative bacteria, including Pseudomonas aeruginosa, sets it apart. The drug's performance in clinical trials, particularly against meropenem, has strengthened its position[4].

Regulatory Approvals

Merck plans to submit supplemental new drug applications to the FDA and EMA for the new indication of treating HABP and VABP, which could further expand ZERBAXA's market reach[4].

Global Demand

The global demand for effective antibiotics is on the rise due to increasing antibiotic resistance. ZERBAXA's ability to address this need has driven its adoption in various regions, contributing to Merck's overall revenue growth.

Financial Trajectory

Revenue Growth

ZERBAXA's sales have been a part of Merck's strong financial performance. In 2021, despite the initial setback, the drug's resupply and continued demand contributed to Merck's overall revenue growth. The company reported a gross margin of 72.0% for the full year of 2021, partly due to the favorable impact of product mix and lower inventory write-offs[2].

Impact on Merck's Financials

In the third quarter of 2022, Merck's hospital segment, which includes ZERBAXA, saw robust growth. This segment's performance was driven by increased demand for key products, including ZERBAXA, following the completion of its global resupply[3].

Challenges and Opportunities

While ZERBAXA has faced challenges such as product recalls and competitive market pressures, its clinical efficacy and expanding indications present significant opportunities for growth. The planned submissions for new indications in HABP and VABP could further bolster its financial trajectory.

Key Takeaways

• Clinical Efficacy: ZERBAXA has demonstrated non-inferiority to meropenem in treating cUTI, cIAI, and potentially HABP and VABP.
• Market Approval: Published in prestigious journals, reinforcing its clinical significance.
• Financial Performance: Contributed to Merck's revenue growth despite temporary setbacks.
• Global Demand: Addresses the growing need for effective antibiotics against Gram-negative bacteria.
• Regulatory Approvals: Planned submissions for new indications could expand its market reach.

FAQs

1. What are the primary indications for ZERBAXA?

   • ZERBAXA is indicated for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) in adult patients.

2. What was the outcome of the Phase 3 clinical studies for ZERBAXA?

   • The Phase 3 studies demonstrated that ZERBAXA met the pre-specified primary endpoints for treating cUTI and cIAI, and also showed non-inferiority to meropenem in treating HABP and VABP[1][4].

3. How did the product recall affect ZERBAXA's sales?

   • The product recall in the fourth quarter of 2020 led to a suspension of sales, but a phased resupply initiated in the fourth quarter of 2021 helped in regaining market traction[2].

4. What are the planned regulatory submissions for ZERBAXA?

   • Merck plans to submit supplemental new drug applications to the FDA and EMA for the new indication of treating HABP and VABP[4].

5. How has ZERBAXA contributed to Merck's financial performance?

   • ZERBAXA has been a significant contributor to Merck's revenue, particularly in the hospital segment, and has helped in maintaining strong financial performance despite challenges[2][3].

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 News.
2. Merck Announces Fourth-Quarter and Full-Year 2021 Financial Results - Merck Q4FY21 Earnings News Release.
3. Merck Q3 2022 Earnings - Merck Q3 2022 Earnings Deck.
4. Merck's ZERBAXA® (ceftolozane and tazobactam) Met Primary Endpoints of Non-Inferiority Compared to Meropenem in Pivotal Phase 3 Study of Adult Patients with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia - Merck News.