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:	1
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
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303-001	Jun 25, 2018		RX	Yes	Yes				Y

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
Mexico	2010005632	ANALOGOS DE AMINOGLUCOSIDOS ANTIBACTERIANOS. (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS.)
Spain	2613936
World Intellectual Property Organization (WIPO)	2009067692
Poland	2217610

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ZEMDRI

Last updated: July 4, 2025

Introduction

In the competitive world of pharmaceuticals, drugs like ZEMDRI—plazomicin, an aminoglycoside antibiotic—highlight the delicate balance between innovation, market forces, and financial viability. Developed by Achaogen, ZEMDRI entered the market in 2018 as a treatment for complicated urinary tract infections (cUTIs) caused by multidrug-resistant bacteria. As antibiotic resistance escalates globally, stakeholders from investors to healthcare executives must understand ZEMDRI's market dynamics and financial path to navigate risks and opportunities effectively.

This analysis delves into the forces shaping ZEMDRI's position, including regulatory hurdles, competitive pressures, and revenue trends, drawing on real-world data to inform strategic decisions.

Background on ZEMDRI

ZEMDRI represents a critical advancement in combating antimicrobial resistance, targeting gram-negative bacteria such as Escherichia coli and Klebsiella pneumoniae. The U.S. Food and Drug Administration (FDA) granted it fast-track approval in June 2018, recognizing its potential in treating infections where traditional antibiotics fall short. Achaogen positioned ZEMDRI as a once-daily intravenous option, differentiating it from older aminoglycosides like gentamicin through reduced nephrotoxicity risks.

However, ZEMDRI's development was not without challenges. Achaogen invested heavily in clinical trials, including Phase 3 studies that demonstrated non-inferiority to meropenem in cUTI patients. Despite this, the drug's market entry coincided with a broader industry shift toward stewardship programs, which prioritize judicious antibiotic use to prevent resistance. This context has influenced ZEMDRI's adoption rates, making it a case study in how scientific merit alone does not guarantee commercial success.

Market Dynamics of ZEMDRI

The antibiotic market is a high-stakes arena, valued at over $45 billion globally in 2023, with projections reaching $64 billion by 2030, according to industry reports. ZEMDRI operates in the subset of anti-infectives for resistant infections, where demand surges due to rising bacterial threats. Yet, it faces intense competition from established players like Merck's Zerbaxa and Pfizer's Zyvox, which benefit from broader indications and entrenched physician preferences.

Regulatory dynamics play a pivotal role. The FDA's approval of ZEMDRI under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) expedited its launch but restricted its market to specific patient groups, limiting broader reimbursement and sales potential. In Europe, the European Medicines Agency (EMA) has not approved ZEMDRI, confining its availability primarily to the U.S. and select markets, which constrains global revenue streams.

Market entry barriers further complicate ZEMDRI's trajectory. Patent protections, including Achaogen's original filings for plazomicin compositions (e.g., U.S. Patent No. 9,732,349), expire in the mid-2030s, but generic threats loom earlier through potential challenges via the Hatch-Waxman Act. This regulatory framework allows competitors to file Abbreviated New Drug Applications (ANDAs) once patents are contested, potentially eroding ZEMDRI's market share.

Consumer and prescriber behavior also shapes dynamics. Hospitals prioritize cost-effective options, and ZEMDRI's pricing—at around $2,500 per course—often competes poorly against generics. Moreover, stewardship guidelines from organizations like the Centers for Disease Control and Prevention (CDC) encourage reserving new antibiotics for last-resort scenarios, dampening routine use. Data from IQVIA shows ZEMDRI captured less than 1% of the U.S. cUTI market in its first year, underscoring how these factors stifle growth.

On the upside, emerging opportunities arise from partnerships and pipeline expansions. For instance, after Achaogen's bankruptcy in 2019, Cipla acquired ZEMDRI rights, enabling potential relaunches in new regions. The global push for antimicrobial innovation, backed by initiatives like the World Health Organization's (WHO) AWaRe classification, could boost demand if ZEMDRI aligns with access programs.

Financial Trajectory of ZEMDRI

ZEMDRI's financial story began with optimism but quickly turned turbulent. Achaogen raised over $300 million through initial public offerings and partnerships before launch, betting on ZEMDRI as a blockbuster. Early projections estimated peak annual sales at $500 million, driven by the unmet need in resistant infections.

Reality diverged sharply. In 2018, ZEMDRI generated just $1.6 million in revenue, far below expectations, as reported in Achaogen's SEC filings. The company's bankruptcy filing in April 2019 cited inadequate sales uptake, exacerbated by pricing pressures and slow hospital adoption. This led to a 90% stock plunge, wiping out investor value and highlighting the risks of over-reliance on a single asset.

Post-acquisition by Cipla in 2019, ZEMDRI's financial path stabilized somewhat. Cipla's 2023 annual report indicated modest revenue contributions from ZEMDRI, estimated at $10-15 million annually in the U.S., buoyed by niche applications in resistant cases. However, global expansion remains limited; for example, filings with the Indian regulatory body show no immediate plans for domestic launch, restricting revenue diversification.

Cost structures add another layer. Developing and marketing ZEMDRI involved over $200 million in R&D, as per Achaogen's disclosures, with ongoing manufacturing expenses keeping profit margins slim. Cipla's economies of scale have helped mitigate these, but external factors like supply chain disruptions during the COVID-19 pandemic further dented sales.

Looking ahead, financial forecasts hinge on strategic pivots. Analysts from Evaluate Pharma predict ZEMDRI could reach $50 million in annual sales by 2025 if Cipla expands into emerging markets like Latin America. Yet, patent expirations and biosimilar competition pose downside risks, potentially halving revenues by 2030. Investors should monitor metrics like net present value (NPV) and return on investment (ROI), which for ZEMDRI currently hover near break-even based on recent financial models.

Challenges and Opportunities

ZEMDRI's journey exposes key challenges in the pharma sector: regulatory stringency, market saturation, and financial volatility. The drug's LPAD designation, while accelerating approval, narrowed its addressable market, illustrating how targeted pathways can limit scalability. Additionally, antibiotic overuse concerns have led to payer pushback, with insurers often denying coverage for non-essential uses.

Opportunities abound for revival. Collaborations with public health entities, such as the Biomedical Advanced Research and Development Authority (BARDA), could fund expanded trials or new indications. ZEMDRI's potential in combination therapies for sepsis or pneumonia represents untapped growth, especially as global resistance rates climb—WHO data shows over 700,000 annual deaths from resistant infections.

Executives must weigh these against financial realities. A diversified portfolio, like Cipla's, reduces single-drug dependency, offering a blueprint for sustainability.

Conclusion

ZEMDRI's market dynamics and financial trajectory underscore the complexities of innovating in antibiotics, where scientific breakthroughs meet economic hurdles. By examining these elements, business professionals can better anticipate industry shifts and refine investment strategies.

Key Takeaways

• ZEMDRI's market remains niche due to regulatory restrictions and competition, capturing less than 1% of the U.S. cUTI segment.
• Financial performance has been volatile, with early revenues falling short of projections, leading to Achaogen's bankruptcy and Cipla's acquisition.
• Patent protections extend into the 2030s, but generic threats could erode market share, emphasizing the need for strategic expansions.
• Opportunities in emerging markets and combination therapies could drive future growth, contingent on overcoming stewardship and pricing barriers.
• Investors should prioritize ROI analysis, as ZEMDRI's trajectory highlights risks in high-R&D fields like antibiotics.

FAQs

1. What makes ZEMDRI unique in the antibiotic market?
ZEMDRI stands out for its efficacy against multidrug-resistant bacteria, offering a once-daily dosing option with lower nephrotoxicity compared to traditional aminoglycosides, though its LPAD approval limits widespread use.

2. How has ZEMDRI's financial trajectory impacted its parent companies?
Achaogen's bankruptcy in 2019 stemmed from ZEMDRI's underwhelming sales, while Cipla has integrated it into a broader portfolio, achieving modest revenues and using it to strengthen their anti-infective offerings.

3. What regulatory factors most affect ZEMDRI's market dynamics?
The FDA's LPAD pathway expedited approval but restricted ZEMDRI to limited populations, and the lack of EMA authorization has confined it mostly to the U.S., hindering global market penetration.

4. Are there upcoming opportunities for ZEMDRI's growth?
Yes, potential expansions into new indications like sepsis and partnerships with organizations like BARDA could boost demand, especially in regions with high resistance rates.

5. How can investors assess ZEMDRI's long-term financial viability?
Investors should evaluate metrics such as NPV from sales forecasts, monitor patent litigation outcomes, and track global resistance trends to gauge ZEMDRI's potential in an evolving market.

Sources

1. U.S. Food and Drug Administration. "FDA approves new antibacterial drug ZEMDRI." FDA.gov, June 2018.
2. Achaogen Inc. "Annual Report (Form 10-K)." U.S. Securities and Exchange Commission, 2018.
3. Cipla Ltd. "Annual Report." Cipla.com, 2023.
4. IQVIA Institute. "The Global Use of Medicines 2023 Outlook." IQVIA.com, 2023.
5. World Health Organization. "Antimicrobial Resistance: Global Report on Surveillance." WHO.int, 2022.