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 five 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-four 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:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Patent Applications:	1,772
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 five US patents and one FDA Regulatory Exclusivity.

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	212045-001	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
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
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
Japan	7114570
European Patent Office	3177146	AEROSOL SUBLINGUAL DE NALOXONE (SUBLINGUAL NALOXONE SPRAY)
Japan	2019528278	液体ナロキソンスプレー
China	109922805
World Intellectual Property Organization (WIPO)	2018034920
Japan	2022119843	液体ナロキソンスプレー

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

KLOXXADO Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for KLOXXADO

Introduction

KLOXXADO, an 8mg naloxone HCl nasal spray, has been a significant player in the market for opioid overdose reversal since its launch in the US in August 2021. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Market Entry and Competition

KLOXXADO, developed by Hikma Pharmaceuticals, entered the market with a competitive edge, containing twice as much naloxone per spray as the standard Narcan Nasal Spray 4mg. This higher dosage addresses the increasing prevalence of potent illicitly manufactured synthetic opioids, which often require more naloxone to reverse overdose effects[4].

Price Dynamics

The introduction of KLOXXADO has significantly impacted the pricing landscape of naloxone products. Prior to its launch, Narcan held a near-monopoly, with prices that were significantly higher. For instance, a two-dose kit of Narcan cost $75 for governments and non-profits just a year ago. However, with the entry of KLOXXADO and other generic naloxone products, prices have plummeted. The state pharmacy now negotiates prices as low as $40.21 per kit for generic naloxone nasal sprays, forcing Narcan to reduce its price to $47.50 per kit[1].

Market Share and Distribution

Since its introduction, KLOXXADO has made notable inroads into Narcan's market share. By August 2021, the state pharmacy had shipped 37,126 KLOXXADO kits, although this is still a fraction of the 187,029 Narcan kits delivered during the same period. Nonetheless, this represents a significant shift in market dynamics, indicating a growing acceptance and adoption of KLOXXADO[1].

Economic Drivers

The economic drivers behind the pricing and market dynamics of KLOXXADO are multifaceted. The opioid epidemic has driven up demand for naloxone, leading to price increases in the past. However, the recent entry of generics and higher-dose alternatives like KLOXXADO has reversed this trend. The cumulative price increases for naloxone products prior to 2012 were largely due to increased demand and single-supplier markets. Since 2012, prices have seen more dramatic increases, partly due to drug shortages and the dominance of single competitors[3].

Regulatory and Policy Implications

The decreasing prices of naloxone products, including KLOXXADO, are likely to pressure the industry and government to make naloxone an over-the-counter (OTC) drug. This move would further reduce prices, as consumers rather than insurers and governments would bear the costs. Harm Reduction Ohio, a major naloxone distributor, has already shifted its focus towards generic naloxone, indicating a broader trend towards more accessible and affordable naloxone products[1].

Public Health Impact

The launch of KLOXXADO has been welcomed as a critical tool in the fight against the opioid epidemic. With the number of overdose deaths involving opioids rising significantly, higher-dose naloxone products are seen as essential. For example, studies have shown that 34% of attempted reversals using Narcan required two or more doses, highlighting the need for higher-dose options like KLOXXADO[4].

Financial Projections and Strategic Plans

Hikma Pharmaceuticals, the manufacturer of KLOXXADO, is committed to ensuring the drug's wide accessibility. As part of their strategic plan, Hikma aims to leverage its capabilities in addiction therapy treatments and nasal spray production to make KLOXXADO a cornerstone in the public health response to opioid overdoses. The company's financial projections include continued investment in infrastructure, manufacturing, and commercial infrastructure to support the growth of KLOXXADO and other products[2][4].

Industry Expert Insights

Industry experts like Daniel Buffington, a clinical pharmacology specialist, emphasize the importance of higher-dose naloxone products in addressing the opioid epidemic. "As a ready-to-use nasal spray that contains twice as much naloxone per spray than the current standard of care, KLOXXADO provides an important new treatment for those suffering from an opioid overdose," he noted[4].

Future Outlook

The future outlook for KLOXXADO is promising, with ongoing efforts to make naloxone more accessible and affordable. As prices continue to drop and more generic options enter the market, the demand for KLOXXADO and similar products is expected to rise. The push for OTC status and the increasing recognition of the need for higher-dose naloxone products position KLOXXADO for continued growth and impact in the public health sector.

Key Takeaways

• Market Competition: KLOXXADO has entered the market with a higher dose than Narcan, capturing a significant share.
• Price Reductions: The introduction of KLOXXADO and generic naloxone products has led to substantial price reductions.
• Public Health Impact: Higher-dose naloxone products like KLOXXADO are crucial in addressing the opioid epidemic.
• Regulatory Implications: There is growing pressure to make naloxone an OTC drug, which could further reduce prices.
• Financial Projections: Hikma Pharmaceuticals is investing in infrastructure and commercial capabilities to support KLOXXADO's growth.

FAQs

Q: What is KLOXXADO, and how does it differ from Narcan? A: KLOXXADO is an 8mg naloxone HCl nasal spray, containing twice as much naloxone per spray as Narcan Nasal Spray 4mg, making it more effective against potent synthetic opioids.

Q: How has the introduction of KLOXXADO affected the pricing of naloxone products? A: The introduction of KLOXXADO and other generic naloxone products has led to significant price reductions, with prices dropping from $75 per kit to as low as $40.21 per kit.

Q: What are the public health implications of KLOXXADO? A: KLOXXADO provides a higher-dose option that is essential in reversing overdoses caused by potent synthetic opioids, which are increasingly prevalent.

Q: Is KLOXXADO likely to become an over-the-counter drug? A: Yes, the decreasing prices and growing demand for naloxone products are likely to pressure the industry and government to make naloxone an OTC drug.

Q: How is Hikma Pharmaceuticals supporting the distribution and accessibility of KLOXXADO? A: Hikma is committed to ensuring KLOXXADO's wide accessibility, investing in infrastructure, manufacturing, and commercial capabilities to support its growth and distribution.

Sources

1. Harm Reduction Ohio - What naloxone price cuts mean for preventing overdose deaths
2. Emergent BioSolutions - 2021 Annual Report
3. PubMed - Trends and economic drivers for United States naloxone pricing
4. PR Newswire - Hikma announces US launch of KLOXXADO™ (naloxone HCl) nasal spray 8mg
5. Pennsylvania State Legislature - Testimony on the Proposed Fiscal Year 2024-25 Department of Drug and Alcohol Programs Budget