KLOXXADO Drug Patent Profile

When do Kloxxado patents expire, and what generic alternatives are available?

Kloxxado is a drug marketed by Hikma and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has fourteen patent family members in seven countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kloxxado

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

Summary for KLOXXADO

International Patents:	14
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Patent Applications:	2,432
Drug Prices:	Drug price information for KLOXXADO
What excipients (inactive ingredients) are in KLOXXADO?	KLOXXADO excipients list
DailyMed Link:	KLOXXADO at DailyMed

See drug prices for KLOXXADO

Pharmacology for KLOXXADO

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Paragraph IV (Patent) Challenges for KLOXXADO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KLOXXADO	Nasal Spray	naloxone hydrochloride	8 mg/spray	212045	1	2023-03-30

US Patents and Regulatory Information for KLOXXADO

KLOXXADO is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	KLOXXADO	naloxone hydrochloride	SPRAY;NASAL	212045-002	Aug 25, 2025		RX	Yes	No
Hikma	KLOXXADO	naloxone hydrochloride	SPRAY;NASAL	212045-001	Apr 29, 2021		RX	Yes	Yes			Y
Hikma	KLOXXADO	naloxone hydrochloride	SPRAY;NASAL	212045-001	Apr 29, 2021		RX	Yes	Yes			Y
Hikma	KLOXXADO	naloxone hydrochloride	SPRAY;NASAL	212045-001	Apr 29, 2021		RX	Yes	Yes			Y

International Patents for KLOXXADO

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

Country	Patent Number	Title	Estimated Expiration
Australia	2017312811
World Intellectual Property Organization (WIPO)	2018034920
World Intellectual Property Organization (WIPO)	2016007245
World Intellectual Property Organization (WIPO)	2016007245

Supplementary Protection Certificates for KLOXXADO

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 KLOXXADO

Last updated: July 27, 2025

Introduction

KLOXXADO (naltrexone HCl) extends the opioid antagonism portfolio with a novel sublingual formulation designed to combat opioid overdose. Approved by the FDA in December 2021, KLOXXADO is positioned as a critical tool amidst escalating opioid overdose crises in the United States, leveraging a unique combination of clinical efficacy, regulatory support, and strategic market positioning. Analyzing its market dynamics and financial trajectory requires an understanding of the evolving opioid epidemic, regulatory landscape, competitive environment, and potential adoption trends.

Market Overview and Context

The Opioid Epidemic and Regulatory Drive

The United States continues to grapple with an opioid overdose epidemic, with over 100,000 annual deaths reported in recent years (CDC, 2022). Regulatory agencies, including the FDA, have prioritized expanding access to overdose reversal agents, especially formulations suited for emergency and community settings. The persistent need for effective, user-friendly, and accessible naloxone formulations has driven substantial market growth, creating fertile ground for innovative products like KLOXXADO.

Existing Market for Opioid Overdose Reversal Agents

The primary class of drugs for overdose reversal comprises naloxone formulations, available as injectable, nasal spray (Narcan), and auto-injectors. Naloxone’s widespread use has been facilitated by legislative efforts: standing orders, pharmacy access, and Medicaid coverage have increased availability (FDA, 2020). Yet, demand for improved access, ease of administration, and formulations tailored for community use fuels ongoing innovation.

Distinct Features of KLOXXADO

KLOXXADO is a high-dose, sublingual tablet delivering 8 mg of naltrexone, designed for rapid and effective opioid antagonism. Unlike naloxone, naltrexone’s longer duration may offer benefits in certain settings, including comprehensive overdose management. Its sublingual route favors ease of use over traditional injection, potentially expanding access and compliance.

Market Dynamics

Competitive Landscape

The opioid overdose reversal market is dominated by naloxone-based products. Narcan (naloxone HCl) remains the market leader, supported by broad distribution networks, legislative backing, and extensive public awareness campaigns. Notably, the market entry of KLOXXADO introduces a new player with unique pharmacological properties and administration advantages.

KLOXXADO’s niche is its potential integration into treatment paradigms for opioid use disorder (OUD), where naltrexone formulations are indicated for relapse prevention. This positions KLOXXADO not solely as an emergency overdose agent but also as part of medication-assisted treatment (MAT), differentiating it from naloxone products.

Market Adoption Drivers

• Regulatory Approvals and Incentives: The FDA’s approval of KLOXXADO validates its safety and efficacy profile, supporting market entry. Its approval as a rescue medication increases accessibility through standing orders and pharmacy distribution.
• Healthcare Provider Perception: Clinicians’ acceptance hinges on evidence demonstrating the drug’s safety, efficacy, and ease of use compared to existing options.
• Public Health Initiatives: State and federal programs advocating for overdose reversal agents bolster market demand. Education campaigns emphasizing convenience and rapid action could enhance adoption.
• COVID-19 Pandemic Impact: The pandemic has heightened awareness of emergency preparedness, emphasizing the need for accessible overdose reversal agents.

Barriers to Market Penetration

• Conservative Prescribing Practices: Clinicians may prefer familiar naloxone formulations, with limited familiarity with naltrexone-based agents.
• Cost and Reimbursement: Pricing strategies and insurance coverage significantly influence adoption. High costs or limited coverage could impede widespread use.
• Market Saturation: The entrenched position of naloxone products limits early market share expansion. Overcoming brand loyalty and awareness is crucial.

Market Potential and Forecast

Given the size of the opioid overdose market, with over $1 billion in annual expenditures on naloxone products alone, KLOXXADO’s potential share could be substantial if positioned for both rescue and treatment roles. Analysts project a compound annual growth rate (CAGR) of 7-10% for overdose reversal agents over the next five years, driven by legislative mandates, public health campaigns, and emerging adoption of extended-release naltrexone formulations (Grand View Research, 2022).

Initially targeting high-incidence regions and specialty clinics, KLOXXADO could expand via strategic collaborations with healthcare systems, Medicaid, and public health programs, projecting revenues potentially in the hundreds of millions within five years, assuming successful market penetration.

Financial Trajectory

Revenue Projections

• Launch Phase (Year 1-2): Revenue surge anticipated from early adopters, including addiction clinics, hospitals, and emergency services. Limited by initial awareness and distribution reach.
• Growth Phase (Year 3-5): As prescription volume expands, driven by clinician familiarity and policies favoring naltrexone agents for relapse prevention, revenues could experience significant upticks.
• Maturity Phase (Year 5+): Market penetration stabilizes, with sales plateauing unless new formulations or indications emerge.

Pricing Strategy and Reimbursement

KLOXXADO’s pricing will influence its market share. As a specialty formulation, premiums over generic naloxone products are expected. Nonetheless, reimbursement supports, including Medicaid coverage, are critical. Ensuring coverage parity with naloxone forms could accelerate adoption.

Investment and Commercialization Efforts

Ongoing investments in education campaigns, distribution channels, and clinician outreach will shape financial outcomes. The company’s ability to leverage partnerships with public health agencies and inclusion in formulary listings will be pivotal.

Potential Risks and Mitigation

Risks include slower-than-expected adoption, regulatory hurdles, and competitive innovations. To mitigate these, the company must invest in clinical evidence generation, strategic marketing, and stakeholder engagement.

Conclusion

KLOXXADO’s market dynamics rest on its capacity to carve a niche within an expanding overdose reversal market while leveraging its unique formulation advantages. Its financial trajectory depends on strategic positioning, regulatory support, and broader public health initiatives. The drug’s success will be dictated by its ability to demonstrate added value over existing naloxone-based products and its integration into both emergency and treatment settings.

Key Takeaways

• The opioid overdose crisis sustains robust demand for reversal agents, favoring innovative solutions like KLOXXADO.
• KLOXXADO’s positioning as both an emergency and treatment tool offers differentiation but requires clinician education and broad acceptance.
• Market growth is driven by legislative support, public health campaigns, and increasing awareness of overdose management.
• Pricing, reimbursement, and distribution strategies are critical to achieving significant market penetration.
• The drug’s financial success hinges on effective stakeholder engagement, clinical evidence, and strategic partnerships.

FAQs

1. How does KLOXXADO differ from naloxone-based overdose reversal drugs?
   KLOXXADO contains a high-dose naltrexone formulation indicated for specific overdose and treatment scenarios, offering extended antagonism. Unlike naloxone, which acts rapidly and short-term, KLOXXADO’s pharmacokinetics provide a different clinical profile, potentially benefiting certain patient populations.

2. What regulatory approvals has KLOXXADO received?
   The FDA approved KLOXXADO in December 2021 for the treatment of opioid overdose and relapse prevention, lifting barriers to market access and reimbursement.

3. What are the main barriers to KLOXXADO’s market adoption?
   Barriers include clinician familiarity with existing naloxone products, cost considerations, insurance coverage, and competition from well-established overdose reversal agents.

4. What is the potential market size for KLOXXADO?
   The broader overdose reversal market exceeds $1 billion annually, with potential for significant growth. KLOXXADO could capture a substantial share if positioned effectively within emergency and treatment contexts.

5. How might public health policies influence KLOXXADO’s success?
   Policies promoting broad access to overdose reversal agents, funding for addiction treatment, and inclusion in formulary listings can significantly accelerate adoption.

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Sources

1. CDC. (2022). Drug Overdose Deaths. [online] Available at: https://www.cdc.gov/drugoverdose/data/statedeaths.html
2. FDA. (2020). Opioid Overdose Reversal Drug Products. [online] Available at: https://www.fda.gov/drugs/information-drug-class/opioid-overdose-reversal-drug-products
3. Grand View Research. (2022). Opioid Overdose Reversal Market Analysis.
4. U.S. Food and Drug Administration. (2021). KLOXXADO (naltrexone) Sublingual Tablets. [FDA Press Release].