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ZEMDRI Drug Patent Profile

When do Zemdri patents expire, and what generic alternatives are available?

Zemdri is a drug marketed by Cipla Usa and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-eight patent family members in twenty-one countries.

The generic ingredient in ZEMDRI is plazomicin sulfate. Three suppliers are listed for this compound. Additional details are available on the plazomicin sulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Zemdri

Zemdri was eligible for patent challenges on June 25, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 2, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZEMDRI

International Patents:	28
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	1
Patent Applications:	107
Drug Prices:	Drug price information for ZEMDRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZEMDRI
DailyMed Link:	ZEMDRI at DailyMed

See drug prices for ZEMDRI

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

NDA:

210303

Dosage:

SOLUTION;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 ZEMDRI

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

Sponsor	Phase
Cipla USA Inc.	Phase 1

See all ZEMDRI clinical trials

US Patents and Regulatory Information for ZEMDRI

ZEMDRI is protected by four US patents and two FDA Regulatory Exclusivities.

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
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303-001	Jun 25, 2018		RX	Yes	Yes				Y
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303-001	Jun 25, 2018		RX	Yes	Yes			Y
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303-001	Jun 25, 2018		RX	Yes	Yes

International Patents for ZEMDRI

When does loss-of-exclusivity occur for ZEMDRI?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

Poland

Portugal

Slovenia

South Korea

Spain

Taiwan

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 ZEMDRI around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201070597	АНТИБАКТЕРИАЛЬНЫЕ АНАЛОГИ АМИНОГЛИКОЗИДА
Eurasian Patent Organization	017824	АНТИБАКТЕРИАЛЬНЫЕ АНАЛОГИ АМИНОГЛИКОЗИДА (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS)
Croatia	P20170154

ZEMDRI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZEMDRI (Plazomicin)

Introduction

ZEMDRI, also known as plazomicin, is a novel aminoglycoside antibacterial developed by Achaogen to treat complicated urinary tract infections (cUTI) and other infections caused by highly resistant Enterobacteriales. Despite its innovative potential, the drug's market and financial performance have been marked by significant challenges.

FDA Approval and Initial Launch

ZEMDRI was approved by the U.S. Food and Drug Administration (FDA) on June 25, 2018, for the treatment of adults with cUTI, including pyelonephritis, due to certain Enterobacterales[4].

• The approval was supported by data from the EPIC (Evaluating Plazomicin In cUTI) clinical trial, which demonstrated non-inferiority to meropenem for the co-primary efficacy endpoints.

Commercial Performance

The commercial launch of ZEMDRI occurred on July 20, 2018. However, the sales figures were disappointingly low.

• For the three months ended December 31, 2018, Achaogen reported ZEMDRI net product sales of $0.5 million, and for the full year 2018, the sales were only $0.8 million[2].

Financial Support and Investment

Despite the poor sales, ZEMDRI had significant financial backing.

• The development of ZEMDRI was supported by over $500 million from the Biomedical Advanced Research and Development Authority (BARDA) and investors[1].
• However, this substantial investment did not translate into commercial success.

Bankruptcy and Acquisition

Achaogen's financial struggles led to the company filing for bankruptcy about a year after ZEMDRI's approval.

• The company's bankruptcy was a direct result of the high development costs and the failure to generate sufficient revenue from ZEMDRI sales[3].

In 2020, Cipla acquired ZEMDRI at a bargain price of $16 million, several months after Achaogen's bankruptcy[1].

European Market Withdrawal

Cipla decided to withdraw the marketing application for ZEMDRI in Europe due to the negligible potential sales and the high costs associated with completing the registration process.

• This decision means that ZEMDRI will not be readily available in Europe, limiting its global market reach[1].

Financial Expenses and Losses

Achaogen's financial reports highlight the significant expenses and losses incurred during the development and commercialization of ZEMDRI.

• Research and Development (R&D) expenses for 2018 were $103.0 million, with a notable increase due to pre-launch activities and other research programs[2].
• Selling, General, and Administrative (SG&A) expenses also increased to $71.4 million in 2018, primarily due to personnel, facility-related costs, and commercialization expenses[2].
• The net loss for 2018 was $186.5 million, reflecting the financial strain on the company[2].

Regulatory and Market Challenges

The development and commercialization of new antibiotics face numerous challenges, including regulatory hurdles and financial constraints.

• The concept of the "valley of death" in biotech, where firms struggle to raise money to advance promising science, is particularly relevant for antibiotics. Achaogen experienced this firsthand with ZEMDRI[3].

Market Expectations and Revenue Projections

Industry experts acknowledge that new antibiotics are unlikely to generate blockbuster returns.

• Basilea's portfolio, which includes other antibacterial products, is estimated to generate peak sales of $500 million to $1 billion per year, but this is not expected to be immediate or guaranteed[3].

Distribution and Availability

Despite the challenges, ZEMDRI is available for purchase in the U.S. through specialty distributors such as ASD Healthcare, Cardinal Health Specialty Distribution, FFF Enterprises, and McKesson Plasma and Biologics[4].

Key Takeaways

• FDA Approval: ZEMDRI was approved by the FDA in June 2018 for treating cUTI.
• Poor Sales: The drug generated only $0.8 million in sales for the full year 2018.
• Financial Backing: Over $500 million in support from BARDA and investors.
• Bankruptcy: Achaogen filed for bankruptcy due to high development costs and low sales.
• Acquisition: Cipla acquired ZEMDRI for $16 million.
• European Market: The marketing application was withdrawn due to high costs and low potential sales.
• Financial Strains: Significant R&D and SG&A expenses contributed to Achaogen's financial losses.

FAQs

What is ZEMDRI used for?

ZEMDRI (plazomicin) is used for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Enterobacterales.

Why did Achaogen file for bankruptcy?

Achaogen filed for bankruptcy due to the high development costs of ZEMDRI and the failure to generate sufficient revenue from its sales.

Who acquired ZEMDRI after Achaogen's bankruptcy?

Cipla acquired ZEMDRI at a bargain price of $16 million several months after Achaogen's bankruptcy.

Why was the marketing application for ZEMDRI withdrawn in Europe?

The marketing application was withdrawn due to the high costs associated with completing the registration process and the negligible potential sales in Europe.

What are the financial projections for new antibiotics like ZEMDRI?

New antibiotics are not expected to generate blockbuster returns. Peak sales are estimated to be in the range of $500 million to $1 billion per year, but this revenue is not immediate and is subject to various market and regulatory challenges.

Sources

1. AMR Solutions: Plazomicin EU marketing application is withdrawn - AMR Solutions
2. GlobeNewswire: Achaogen Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Corporate Update
3. C&EN: New antibiotics are hard to come by. Red tape is making the problem worse
4. ZEMDRI Website: Press Release - Achaogen Launches ZEMDRI™ (plazomicin)