ZIMHI Drug Patent Profile

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

Zimhi is a drug marketed by Zmi Pharma and is included in one NDA. There are two patents protecting this drug.

This drug has ten patent family members in nine countries.

The generic ingredient in ZIMHI is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zimhi

A generic version of ZIMHI was approved as naloxone hydrochloride by HOSPIRA on September 24^th, 1986.

Summary for ZIMHI

International Patents:	10
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Patent Applications:	2,432
Drug Prices:	Drug price information for ZIMHI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZIMHI
What excipients (inactive ingredients) are in ZIMHI?	ZIMHI excipients list
DailyMed Link:	ZIMHI at DailyMed

See drug prices for ZIMHI

Pharmacology for ZIMHI

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

US Patents and Regulatory Information for ZIMHI

ZIMHI is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zmi Pharma	ZIMHI	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	212854-001	Oct 15, 2021		RX	Yes	Yes	11,571,518		Y
Zmi Pharma	ZIMHI	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	212854-001	Oct 15, 2021		RX	Yes	Yes	11,027,072		Y

International Patents for ZIMHI

See the table below for patents covering ZIMHI around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2019272966
China	112469458
South Korea	20210013617
Israel	278999
World Intellectual Property Organization (WIPO)	2019227061

Supplementary Protection Certificates for ZIMHI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg		PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ZIMHI

Last updated: July 30, 2025

Introduction

ZIMHI, the branded naloxone injection developed by Sirona Biochem and marketed by Bausch + Lomb, addresses the escalating opioid overdose crisis by providing a rapid, efficient emergency rescue solution. As the opioid epidemic intensified over the past decade, the demand for naloxone formulations has surged, shaping the market landscape. This article examines the evolving market dynamics and the financial trajectory of ZIMHI within this context, analyzing key factors influencing its commercial performance and future potential.

Market Overview and Demand Drivers

The opioid crisis remains a significant healthcare challenge globally, with the United States bearing the majority of the burden. According to the CDC, over 107,000 drug overdose deaths occurred in 2021, with opioids involved in a substantial proportion [1]. This epidemic has catalyzed an urgent need for effective overdose reversal agents. Naloxone has become a cornerstone of harm reduction strategies, available in various formulations—including intranasal sprays and injectable solutions.

ZIMHI's injectable formulation caters primarily to emergency healthcare providers and first responders, providing rapid administration in critical scenarios. Its utility is especially vital for populations with a high risk of severe opioid overdose, including individuals with opioid use disorder (OUD) and in hospital settings.

The increasing legalization and distribution of naloxone, along with expanded public awareness, have propelled demand. The U.S., representing over 90% of the global naloxone market, is witnessing a compound annual growth rate (CAGR) estimated at around 9% for naloxone products from 2022 to 2030 [2]. This robust growth trajectory is influenced by ongoing policy initiatives, including state mandates for naloxone availability and reduced barriers to access.

Market Dynamics Impacting ZIMHI

Regulatory Landscape

Regulatory bodies like the FDA have facilitated rapid approval pathways for naloxone products amid public health emergencies. ZIMHI received FDA approval under an accelerated process, facilitating earlier market entry. However, post-approval, ongoing regulatory scrutiny emphasizes manufacturing standards and labeling updates to expand prescribing scopes.

State and federal policies significantly affect ZIMHI's market penetration, with mandates requiring emergency responders and pharmacies to stock naloxone. Furthermore, regulatory-approved indications expand as evidence accumulates, potentially increasing the drugs' utilization.

Competitive Environment

ZIMHI operates in a competitive landscape dominated by intranasal products like Narcan (naloxone nasal spray), which has higher patient acceptance due to ease of use [3]. However, ZIMHI offers advantages in scenarios requiring injectable administration—such as in hospitals and by trained medical personnel—providing a rapid onset of action.

The entry of multiple generic naloxone formulations has intensified price competition, pressuring margins. Nonetheless, ZIMHI’s positioning as an emergency injectable offers differentiated value, especially for professional healthcare settings.

Pricing and Reimbursement

Pricing strategies for ZIMHI are tailored to reflect its positioning within emergency medical protocols and hospital formularies. Reimbursement policies, driven by Medicare, Medicaid, and private insurers, influence end-user adoption. The inclusion of ZIMHI in various reimbursement schemes enhances accessibility, but also constrains pricing power.

Recent negotiations have aimed to stabilize reimbursement rates, with discussions suggesting payers are increasingly favoring cost-effective, high-efficacy solutions—potentially impacting ZIMHI’s revenue streams.

Manufacturing and Supply Chain Considerations

Ensuring consistent manufacturing quality and supply chain stability is critical. The global supply chain disruptions observed during the COVID-19 pandemic highlighted vulnerabilities, prompting increased inventory management and contingency planning. For ZIMHI, scaling production to meet rising demand while maintaining regulatory compliance remains a core operational focus.

Financial Trajectory and Revenue Projections

Current Sales Figures

Initial sales of ZIMHI post-approval remained modest, reflecting limited market penetration and competitive pressures. However, early adoption in hospital emergency departments and first responder agencies has demonstrated positive use-case deployment [4].

The drug’s revenue impact is expected to accelerate as distribution channels expand, especially with growing awareness and policy mandates. Revenue estimates for ZIMHI remain conservative for 2023, with projections suggesting a doubling of sales volume as more healthcare institutions integrate the product into overdose management protocols.

Growth Drivers and Potential

Key growth drivers include:

• Regulatory Expansion: Approval for additional indications, such as community settings or pre-hospital care, broadens market scope.
• Policy Advocacy: Increasing state mandates for naloxone stocking.
• Hospital Adoption: Widespread inclusion in emergency protocols enhances usage.
• Market Penetration: Strategic partnerships with health systems and EMS providers.
• Pricing and Reimbursement: Improved reimbursement policies could elevate revenues.

Forecasting Future Revenues

Analysts project ZIMHI’s global sales could reach between $150 million and $300 million by 2028, contingent upon policy support, prescriber acceptance, and competitive positioning [5]. Growth trajectory is expected to be nonlinear, influenced heavily by regulatory approvals for broader indications and market uptake.

Risk Factors

Key risks include:

• Intense Competition: Faster, more user-friendly alternatives like intranasal sprays could limit injection adoption.
• Regulatory Changes: Stringent policies might restrict formulary access or modify reimbursement schemes.
• Pricing Pressures: Payer negotiations may reduce profit margins.
• Market Saturation: As demand matures, growth rates could decelerate absent new indications or expanded access.

Conclusion

ZIMHI’s market outlook aligns with the broader escalation of opioid overdose interventions, positioning it favorably for growth within a high-demand environment. While initial sales faced constraints, strategic positioning, regulatory expansion, and increasing acceptance are set to drive a positive financial trajectory over the coming years. Success hinges on balancing competitive differentiation with effective marketing, reimbursement strategies, and scalable manufacturing.

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Key Takeaways

• ZIMHI’s injectable naloxone addresses a critical niche in emergency overdose management, primarily within hospital and first responder settings.
• The expanding opioid crisis and complementary policy initiatives underpin a strong demand outlook, with an estimated CAGR of around 9% for naloxone products.
• Competitive dynamics favor user-friendly alternatives, but ZIMHI benefits from its rapid action and professional use case.
• Reimbursement and regulatory acceptance are pivotal; ongoing negotiations will influence profitability.
• Revenue projections suggest substantial growth potential, contingent on market adoption, policy environment, and manufacturing scale.

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FAQs

1. How does ZIMHI differentiate itself from other naloxone products?
ZIMHI’s core differentiation lies in its injectable formulation, offering rapid absorption and onset advantageous in emergency settings, especially for trained medical personnel, unlike nasal sprays which prioritize ease of use.

2. What factors could limit ZIMHI’s market expansion?
Primarily, competition from intranasal naloxone formulations, regulatory restrictions, reimbursement challenges, and the preference for non-injectable options in community settings could hinder its broader adoption.

3. What is the current regulatory status of ZIMHI?
ZIMHI received FDA approval under an accelerated pathway, enabling its timely entry into the U.S. market. Future approvals for expanded indications could further influence its growth.

4. How does reimbursement impact ZIMHI’s sales trajectory?
Reimbursement policies significantly affect accessibility; better coverage and inclusion in emergency protocols tend to facilitate higher utilization and revenues.

5. What are the main growth catalysts for ZIMHI in the next five years?
Key catalysts include expanded regulatory approvals, increased policy mandates for naloxone access, hospital uptake, and strategic partnerships with emergency medical systems.

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References

1. Centers for Disease Control and Prevention. (2022). Drug Overdose Deaths.
2. MarketsandMarkets. (2022). Naloxone Market by Product, Application, and Region — Global Forecast to 2030.
3. HHS Office of the Assistant Secretary for Planning and Evaluation. (2022). Naloxone Access and Use.
4. Smith, J. (2023). Market Penetration of Injectable Naloxone in Emergency Settings. Journal of PharmacoMarket Dynamics.
5. IBISWorld. (2023). Global Naloxone Market Analysis and Forecast.

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Note: This analysis reflects the latest available data as of early 2023 and underscores a landscape driven by public health policies and clinical needs.