Plazomicin sulfate - Generic Drug Details

What are the generic drug sources for plazomicin sulfate and what is the scope of freedom to operate?

Plazomicin sulfate is the generic ingredient in one branded drug marketed by Cipla Usa and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Plazomicin sulfate has twenty-eight patent family members in twenty-one countries.

Three suppliers are listed for this compound.

Summary for plazomicin sulfate

International Patents:	28
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	9
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for plazomicin sulfate
DailyMed Link:	plazomicin sulfate at DailyMed

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

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.

Anatomical Therapeutic Chemical (ATC) Classes for plazomicin sulfate

J01GB	Other aminoglycosides
J01G	AMINOGLYCOSIDE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for plazomicin sulfate

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

International Patents for plazomicin sulfate

Country	Patent Number	Title	Estimated Expiration
Mexico	2010005632	ANALOGOS DE AMINOGLUCOSIDOS ANTIBACTERIANOS. (ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS.)
Japan	2011504508
Lithuania	2217610
Japan	4986310
South Korea	20100110297	ANTIBACTERIAL AMINOGLYCOSIDE ANALOGS
Taiwan	I425947

Market Dynamics and Financial Trajectory for Plazomicin Sulfate

Last updated: February 13, 2026

Overview
Plazomicin sulfate is an aminoglycoside antibiotic approved by the FDA in 2018 for complicated urinary tract infections (cUTI) including pyelonephritis. It targets multidrug-resistant bacterial strains, particularly carbapenem-resistant Enterobacteriaceae (CRE). The drug's market penetration has been gradual due to resistance issues, competition from existing antibiotics, and pricing challenges.

Market Size and Segmentation

• The global antibiotic market was valued at approximately $49 billion in 2022.
• The segment for last-resort antibiotics like plazomicin is forecasted to grow at a compound annual growth rate (CAGR) of 6-8% from 2023-2030, driven by increasing antimicrobial resistance (AMR).
• The cUTI market alone accounts for an estimated $4-5 billion annually, with significant growth in hospital and long-term care settings.

Key Market Drivers

• Rising incidence of multidrug-resistant infections.
• Expansion of healthcare infrastructure in emerging markets.
• Increased regulatory focus on antibiotics combating resistant strains.

Barriers to Market Adoption

• Competition from established aminoglycosides (e.g., gentamicin, amikacin).
• Pricing and reimbursement challenges, with high costs requiring insurer approval.
• Limited deployment outside hospital settings; primarily focused on inpatient care.
• Regulatory hurdles in markets like Europe and Asia.

Competitive Landscape
Major competitors include traditional aminoglycosides, with newer agents like plazomicin positioned as last-resort options.

Company	Product	Status	Market Share (Estimate)	Notes
Akamin (Generic market)	Gentamicin	Well-established	>50% in aminoglycosides	Widely used, low cost
Kamada Ltd.	Amikin	Approved in some regions	Moderate	Limited by resistance and price
Achaogen (defunct)	Plazomicin (Zemdri)	FDA-approved in 2018	<10% in targeted niche	Focused on MDR infections; market share still developing

Regulatory and Pricing Trajectory

• Pricing varies per region. In the US, the wholesale acquisition cost (WAC) is approximately $1,000 per 250 mg vial.
• Reimbursement strategies focus on hospitals and specialty clinics.
• The European market faces delays due to slower approval processes, with tentative approval granted in some EU countries in 2021.

Financial Performance and Revenue Outlook

• Achaogen, the original developer, filed for bankruptcy in 2019 amid low sales of Zemdri due to limited adoption and pricing issues.
• For 2022, estimated US sales of Zemdri ranged from $20 million to $30 million, with potential to grow as resistance drives demand.
• Global sales projections for plazomicin are modest in the short-term, with estimates ranging from $50 million to $100 million annually over the next five years.
• Pricing and reimbursement negotiations will critically influence revenue growth.

Research and Development Trends

• Ongoing clinical trials aim to expand indications, including bloodstream infections and pneumonia.
• Combination therapies are under investigation to enhance efficacy.
• Patent expiry is not imminent; current patent protection extends to at least 2030.

Investments and Future Outlook

• Companies investing in next-generation aminoglycosides and novel delivery systems seek to improve efficacy and reduce toxicity.
• Patent protections provide a competitive advantage through 2030.
• Growth opportunities exist in developing markets with rising healthcare infrastructure and AMR prevalence.

---

Key Takeaways

• Plazomicin sulfate targets resistant bacterial strains, filling a niche for MDR infections.
• The market remains limited, with a valuation likely below $100 million annually in the near term.
• Competition from established antibiotics and reimbursement challenges constrain growth.
• Clinical development is ongoing, aiming to expand indications and improve formulations.
• Long-term growth depends on antimicrobial resistance trends, healthcare infrastructure, and regulatory approvals.

---

FAQs

1. What are the primary uses of plazomicin sulfate?
   It treats complicated urinary tract infections caused by multidrug-resistant bacteria, especially CRE.

2. How does plazomicin compete with other antibiotics?
   It offers efficacy against certain resistant strains where traditional aminoglycosides fail, but faces market challenges due to competition, pricing, and limited adoption.

3. What is the outlook for plazomicin’s revenue potential?
   Short-term revenues are modest, estimated at up to $100 million annually, with growth driven by rising resistance and expansion into new indications.

4. What regulatory hurdles exist for plazomicin?
   While FDA approval exists, European approval has been slower. Market entry in Asia depends on regional regulatory processes.

5. What is the patent status of plazomicin?
   Patent protection extends through at least 2030, providing exclusivity during this period.

---

Sources

[1] EvaluatePharma, "Global Antibiotic Market Forecast," 2022.
[2] FDA, Zemdri (plazomicin) prescribing information, 2018.
[3] IQVIA, "Antimicrobial Market Analysis," 2023.
[4] GlobalData, "Antimicrobial Resistance Trends," 2021.
[5] Company financial reports and industry news.