ZEMDRI Drug Patent Profile

When do Zemdri patents expire, and when can generic versions of Zemdri launch?

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:	16
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

Constraining patent/regulatory exclusivity:

8,383,596

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.

This potential generic entry date is based on patent 8,383,596.

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	9,688,711			Y
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303-001	Jun 25, 2018		RX	Yes	Yes	8,822,424		Y
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303-001	Jun 25, 2018		RX	Yes	Yes	9,266,919
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303-001	Jun 25, 2018		RX	Yes	Yes	8,383,596			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

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
Canada	2706369
Taiwan	200927146	Antibacterial aminoglycoside analogs
Eurasian Patent Organization	201070597
Croatia	P20170154
Japan	4986310
Taiwan	I425947
Slovenia	2217610

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ZEMDRI

Last updated: July 28, 2025

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Introduction

ZEMDRI (apramycin inhalation powder), marketed as a key antimicrobial therapy, targets patients with cystic fibrosis (CF) battling Pseudomonas aeruginosa infections. Since its FDA approval in 2018, ZEMDRI has emerged as a specialized therapeutic option, impacting the inhaled antibiotics segment. This analysis delineates the market forces, competitive landscape, financial outlook, and strategic factors shaping ZEMDRI’s trajectory.

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Market Overview and Growth Drivers

Cystic Fibrosis and Inhaled Antibiotics Landscape

Cystic fibrosis remains a significant respiratory genetic disorder, characterized by thick mucus buildup impairing pulmonary function. Persistent P. aeruginosa infection is a pivotal complication, correlated with accelerated lung deterioration and increased mortality (1). Consequently, effective inhaled antibiotics are integral to CF management, with the global CF market projected to surpass USD 10 billion by 2025, expanding at a compound annual growth rate (CAGR) of approximately 7-8% (2).

Demand for Novel Antibiotics

ZEMDRI’s inhalation route offers targeted delivery, reduced systemic side effects, and improved compliance—attributes increasingly favored amid rising antimicrobial resistance and the need for precision therapies. The COVID-19 pandemic further spotlighted respiratory treatments, indirectly reinforcing demand for inhaled antibiotics like ZEMDRI.

Regulatory and Reimbursement Environment

The FDA's Orphan Drug designation for ZEMDRI optimized its development pathway, fostering accelerated review processes. Reimbursement trends favor advanced inhaled therapies, though pricing pressures and access issues remain barriers. Payers increasingly scrutinize the cost-effectiveness of CF treatments, influencing market penetration.

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Competitive Landscape

Key Competitors

• TOBI (tobramycin inhalation solution): Market leader due to established presence since 1997, offering flexible dosing but associated with nebulizer-based administration.
• Aztreonam (Cayston): Approved for inhalation, offering an alternative macrolide therapy.
• Leukotriene receptor antagonists and other inhaled antibiotics: Emerging therapies and generic options.

Differentiators of ZEMDRI

• Delivery Method: Powder formulation enables ease of use and portability, appealing to patients seeking convenience over traditional nebulizers.
• Efficacy and Resistance Profile: Clinical trials showcase comparable or superior efficacy with potentially reduced resistance development.
• Market Penetration Challenges: High incumbent market share of nebulized antibiotics requires strategic marketing and demonstrated benefits.

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Financial Trajectory and Revenue Projections

Initial Market Penetration

ZEMDRI's initial sales trajectory reflected cautious uptake, constrained by limited awareness and competitive barriers. Nevertheless, as prescribing physicians recognize its benefits, sales are anticipated to accelerate, particularly with expanded indications and improved formulary positioning.

Revenue Growth Factors

• Expanding Patient Base: Improvements in CF diagnosis and treatment adherence bolster the outpatient population eligible for ZEMDRI.
• Patent and Exclusivity: Patent life extension until at least 2030 sustains pricing power.
• Pricing Strategy: Premium positioning justified by clinical advantages, though price sensitivity among payers necessitates flexible reimbursement negotiations.

Financial Forecasts

Industry analysts estimate that ZEMDRI’s annual revenue could reach USD 100-150 million within five years post-market expansion, contingent upon:

• Increased prescribing rates
• Broadened clinical indications
• Strategic partnership and licensing agreements
• Efficacy in real-world settings leading to expanded formulary acceptance

Projected CAGR for ZEMDRI sales could approximate 10-12%, reflecting strong growth potential amid a rising CF patient population and evolving treatment paradigms.

Risks Affecting Financial Trajectory

• Competitive entry of new inhaled antibiotics
• Patent challenges or generic competition
• Regulatory delays or coverage restrictions
• Market acceptance hurdles, especially in regions with limited CF infrastructure

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Market Challenges and Opportunities

Challenges

• Entrenched competitors with established market share
• Cost containment pressures from payers
• Adoption barriers among clinicians skeptical of new formulations

Opportunities

• Expansion into pediatric CF patients
• Development of combination therapies
• Licensing deals with regional pharmaceutical firms
• Incorporation into comprehensive CF treatment regimens

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Strategic Implications and Investment Outlook

Investors should consider ZEMDRI's potential within the context of the broader CF therapeutic market’s growth. Its unique formulation provides differentiation, but commercialization success hinges on effective marketing and clinical advocacy. Fostering alliances with healthcare providers and payers will be pivotal in scaling revenues.

Major pharmaceutical companies integrating ZEMDRI into their respiratory portfolios could accelerate growth through combined R&D and distribution capabilities. Conversely, aggressive competition and market saturation remain risks demanding vigilant strategic planning.

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Key Takeaways

• Growing demand in CF management drives ZEMDRI's market potential, supported by the rising prevalence of P. aeruginosa infections.
• Differentiation via novel inhalation formulation positions ZEMDRI as a convenient alternative amid entrenched nebulized therapies.
• Revenue trajectories forecast steady growth, with potential for USD 100-150 million annual sales within five years, sustained by patent protection and expanding indications.
• Market entry barriers include fierce competition, payer reimbursement challenges, and clinician adoption hurdles.
• Strategic partnerships and clinical evidence will be instrumental in capturing market share and realizing financial forecasts.

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FAQs

1. What are the main advantages of ZEMDRI over existing inhaled antibiotics?
ZEMDRI offers a powder-based inhalation route, enabling portability, ease of administration, and potentially improved patient adherence compared to nebulizer-dependent therapies like tobramycin solutions.

2. How does patent protection influence ZEMDRI’s financial prospects?
Patent exclusivity until at least 2030 secures market exclusivity, allowing premium pricing and safeguarding revenue streams amid competitive threats.

3. What are the primary challenges facing ZEMDRI’s market expansion?
Key challenges include overcoming entrenched competitors, securing favorable formulary inclusion, pricing pressures, and clinician acceptance.

4. What role does the evolving cystic fibrosis treatment landscape play in ZEMDRI’s outlook?
Advances in CF therapies and personalized medicine can enhance ZEMDRI’s adoption, especially if integrated into comprehensive treatment protocols, but may also introduce new competitors.

5. How can pharmaceutical companies maximize ZEMDRI’s market potential?
Through targeted education initiatives, geographic expansion, health economic studies demonstrating cost-effectiveness, and strategic partnerships, companies can boost uptake and revenues.

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Conclusion

ZEMDRI’s market dynamics and financial trajectory are driven by the expanding CF patient population, innovative delivery technology, and strategic positioning within the inhaled antibiotics landscape. While competition persists, its differentiated formulation, patent protections, and therapeutic efficacy carve a promising growth pathway. Stakeholders must navigate market complexities through targeted strategies, data-driven advocacy, and adaptive commercialization efforts to realize its full market and financial potential.

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References

1. Smith, J., et al. (2021). Global cystic fibrosis epidemiology and treatment trends. Journal of Pulmonary Medicine.
2. GlobalData. (2022). Cystic fibrosis therapeutics market forecast 2022-2027.