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-five 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:	2
Raw Ingredient (Bulk) Api Vendors:	57
Patent Applications:	1,772
Drug Prices:	Drug price information 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
European Patent Office	3801699	DISPOSITIFS D'URGENCE (EMERGENCY DEVICES)
World Intellectual Property Organization (WIPO)	2019227061
Canada	3100913	DISPOSITIFS D'URGENCE (EMERGENCY DEVICES)
New Zealand	769954	Syringe devices for use in an emergency
Japan	7399887
Australia	2019272966	Emergency devices
Israel	278999	מכשירים לחירום (Emergency devices)

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

ZIMHI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZIMHI

Introduction to ZIMHI

ZIMHI, developed by DMK Pharmaceuticals, is an FDA-approved naloxone hydrochloride injection designed to temporarily reverse the effects of opioid overdose. This drug has gained significant attention due to the escalating opioid crisis, particularly with the rise of fentanyl and other potent opioids.

Regulatory and Commercial Rights

DMK Pharmaceuticals has recently regained the full rights to commercialize ZIMHI after terminating an exclusive commercialization and distribution agreement with US WorldMeds, LLC. This move positions DMK to actively seek new commercialization opportunities in the United States, Canada, and Europe, focusing on generating near-term revenues[1].

Target Market and Demand

The primary target market for ZIMHI in the United States is first responders, given the significant unmet demand for effective opioid overdose reversal agents. The drug's rapid action in restoring breathing and preventing death or prolonged hospitalization, especially in cases of fentanyl overdose, makes it an ideal product for emergency response situations[1].

Market Competition and Need for High-Dose Naloxone

The opioid antagonist market has seen the introduction of several high-dose naloxone products, including ZIMHI and Kloxxado, in response to the increasing potency of illicit opioids like fentanyl. However, there is ongoing debate about the necessity of these high-dose formulations, with some research suggesting they may be unnecessary and pose significant risks and side effects[4].

Financial Incentives and Pricing

To make ZIMHI more accessible, DMK Pharmaceuticals offers a savings card program for patients with commercial insurance, allowing them to pay as little as $0 per prescription. However, this program is not available for those using Medicare, Medicaid, or other federal or state healthcare programs due to federal and state laws[5].

Side Effects and Safety Considerations

ZIMHI can cause serious side effects, including sudden opioid withdrawal symptoms such as body aches, fever, sweating, and increased blood pressure. The drug's short duration of action compared to many opioids necessitates repeated doses and continuous surveillance of the patient until emergency medical assistance is received[2][5].

Clinical Use and Administration

The administration of ZIMHI involves simple steps, but it is crucial to recognize the signs and symptoms of an opioid overdose and to be prepared for the potential need for repeated doses. The drug is administered via an intramuscular injection, and patients must be closely monitored for the return of overdose symptoms[5].

Pharmacokinetics and Metabolism

ZIMHI has a mean plasma half-life of approximately 1.50 hours in healthy adults, with the drug being metabolized in the liver primarily through glucuronide conjugation. The metabolites are excreted in the urine, with about 50% excreted within 24 hours and 60-70% within 72 hours[2].

Market Impact and Expansion

DMK Pharmaceuticals is executing an ambitious operating plan to expand its business relationships both within and outside the United States. This includes seeking new commercialization partnerships to drive long-term growth and maximize benefits for patients and stakeholders. The company's focus on developing novel therapies for opioid use disorder and other neuro-based conditions positions it at the forefront of endorphin-inspired drug design[1].

Industry Context: Opioid Crisis

The opioid crisis, exacerbated by the rise of fentanyl and methamphetamine, continues to be a significant public health concern. Fentanyl has saturated many U.S. drug markets, leading to a high number of fatal overdoses. This context underscores the critical need for effective opioid reversal agents like ZIMHI[3].

Financial Projections and Growth Potential

While specific financial projections for ZIMHI are not publicly detailed, the drug's potential for generating significant revenue is high given the unmet demand and the company's strategic plans for expansion. DMK's ability to secure new commercialization partnerships and expand its market reach will be crucial in realizing this potential[1].

Challenges and Risks

The commercialization of ZIMHI faces several challenges, including regulatory risks, market competition, and the ongoing debate about the necessity of high-dose naloxone formulations. Additionally, the company must navigate the complexities of opioid withdrawal symptoms and the need for repeated doses, which can impact patient compliance and safety[4].

Conclusion

ZIMHI is poised to play a critical role in addressing the opioid overdose crisis, particularly with its rapid action and suitability for use by first responders. DMK Pharmaceuticals' strategic efforts to expand commercialization and develop new therapies position the company for potential long-term growth. However, the market dynamics and regulatory environment will continue to shape the financial trajectory of ZIMHI.

Key Takeaways

• Regulatory Rights: DMK Pharmaceuticals has regained full rights to commercialize ZIMHI.
• Target Market: First responders in the United States, Canada, and Europe.
• Market Need: High demand for effective opioid overdose reversal agents.
• Financial Incentives: Savings card program for patients with commercial insurance.
• Side Effects: Potential for opioid withdrawal symptoms and other serious side effects.
• Clinical Use: Simple administration but requires continuous patient surveillance.
• Market Impact: Significant potential for growth through new commercialization partnerships.
• Industry Context: Part of the broader response to the opioid and fentanyl crisis.

FAQs

What is ZIMHI used for?

ZIMHI is used to temporarily reverse the effects of opioid overdose. It is an FDA-approved naloxone hydrochloride injection.

Who is the primary target market for ZIMHI?

The primary target market for ZIMHI in the United States is first responders.

What are the potential side effects of ZIMHI?

ZIMHI can cause sudden opioid withdrawal symptoms, including body aches, fever, sweating, and increased blood pressure, among others.

How is ZIMHI administered?

ZIMHI is administered via an intramuscular injection. Patients may require repeated doses if overdose symptoms return.

Is ZIMHI covered by insurance?

Patients with commercial insurance may be eligible for a ZIMHI Savings Card, allowing them to pay as little as $0 per prescription. However, this program is not available for those using Medicare, Medicaid, or other federal or state healthcare programs.

What is the financial outlook for ZIMHI?

The financial outlook for ZIMHI is promising due to high demand and DMK Pharmaceuticals' strategic plans for expansion. However, specific financial projections are not publicly detailed.

Sources

1. DMK Pharmaceuticals Regains Full Rights to Commercialize ZIMHI - Biospace
2. ZIMHI (naloxone hydrochloride) - FDA
3. The dynamics of US drug markets - Brookings Institution
4. Changing State Policy to Promote Stronger Opioid Antagonists - Network for Public Health Law
5. Prescription Savings for ZIMHI for Opioid Overdose Rescue - ZIMHI Official Website