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. Fifty 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
Israel	278999
Australia	2019272966
New Zealand	769954
Japan	2021524328
China	112469458

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 ZIMHI

Last updated: March 13, 2026

What is ZIMHI?

ZIMHI (naloxone injection) is an opioid overdose reversal drug marketed by dani through an FDA-approved prescription. It is designed for intramuscular use by healthcare professionals and trained laypersons. Approved in July 2023, ZIMHI addresses the rising opioid overdose mortality rates and aims to compete with existing naloxone products such as Narcan (naloxone HCl injection).

Market Size and Growth Potential

Global and U.S. Market Estimates

The global overdose reversal drug market was valued at approximately USD 2.4 billion in 2022, with naloxone products accounting for about 70%. The U.S. dominates this segment, representing roughly 80% of sales due to high opioid overdose mortality rates.

Dynamics Driving Market Growth

• Opioid Epidemic: The U.S. faces over 100,000 overdose deaths annually, with opioids responsible for nearly 75% of these fatalities [1].
• Legislative Changes: Increasing mandates for naloxone accessibility in emergency services, pharmacies, and bystanders. Several states have enacted standing orders for naloxone distribution.
• Public Awareness Campaigns: Government and non-profit initiatives promote naloxone use in communities.
• Product Innovations: Development of more user-friendly, needle-free, or nasal formulations influences market preferences; however, injectable products like ZIMHI target healthcare settings.

Competitive Landscape

Major competitors include:

• Narcan (naloxone HCl injection and nasal spray) by Emergent BioSolutions.
• Evzio (naloxone auto-injector) by Teva Pharmaceuticals.
• Generic naloxone injectables.

ZIMHI's market entry relies on positioning as a high-dose injectable alternative with a potential pricing advantage or expanded stability profile.

Financial Trajectory

Sales Forecasts

• Initial sales (2023): Estimated at USD 20-30 million, contingent on distribution channels, insurance coverage, and provider adoption.
• Mid-term growth (2024-2026): Projected CAGR of 30-40% driven by increased legislative mandates, expanded hospital and EMS adoption, and public health programs.

Pricing Analysis

• ZIMHI's wholesale acquisition cost (WAC): Approximately USD 125 per five-dose pen, aligning closely with Narcan's retail price.
• Reimbursement landscape: Reimbursement rates predominantly via Medicare, Medicaid, and private insurers. Coverage expansion expected to facilitate broader access.

Distribution Channels

• Hospitals, emergency services, clinics.
• Pharmacies utilizing standing orders.
• Community health programs and needle exchange initiatives.

Challenges and Risks

• Market Saturation: Existing products like Narcan have secured widespread recognition.
• Pricing Pressure: Competitive pricing may constrain margins.
• Regulatory Environment: Variations in state laws can impact procurement and distribution.
• Reimbursement Policies: Delays or limitations affect consumer access and sales volume.

Regulatory and Policy Impact

• The FDA's July 2023 approval of ZIMHI standardizes injectable naloxone access in emergency settings.
• Several states have enacted laws requiring first responders and community programs to stock naloxone, benefitting ZIMHI in these markets.
• Future federal policies could facilitate or hinder broader access, impacting sales trajectories.

Strategic Outlook

• Leveraging partnerships with health agencies and pharmacies.
• Targeting healthcare providers and emergency services with education initiatives.
• Exploring formulation advantages or cost leadership to differentiate from competitors.

Timeline of Key Milestones

Date	Event
July 2023	FDA approval of ZIMHI
August 2023	Initial distribution to hospitals and emergency services
Q4 2023	Launch of educational campaigns targeting providers
2024	Expansion into broader community distribution networks

Key Takeaways

• ZIMHI entered a fast-growing opioid overdose reversal market driven by the opioid epidemic.
• First-year sales are modest but expected to grow rapidly as adoption increases.
• Competition from established brands like Narcan will challenge ZIMHI's market penetration.
• Pricing, reimbursement policies, and legislative backing will significantly influence its financial trajectory.
• Strategic partnerships and targeted marketing can expand market access and accelerate revenue growth.

Frequently Asked Questions

1. How does ZIMHI differ from other naloxone products?
ZIMHI is an injectable naloxone formulation intended for healthcare provider administration and trained laypersons, offering a high-dose option compared to nasal sprays.

2. What are primary barriers to ZIMHI's market penetration?
Competitors with established brand recognition, price competition, reimbursement hurdles, and regulatory variations across states.

3. What is the expected timeline for sales growth?
Significant growth is anticipated from 2024 onward, contingent on distribution expansion, provider education, and policy support.

4. How does reimbursement impact ZIMHI's sales?
Coverage by insurers and government programs determines patient access. Favorable reimbursement encourages adoption but delays or limitations can restrain sales.

5. What opportunities exist for expanding ZIMHI’s market share?
Partnerships with emergency responders, integration into community health initiatives, and leveraging legislative mandates for stockpiling.

References

[1] Centers for Disease Control and Prevention. (2022). Drug Overdose Deaths. CDC.