NARCAN Drug Patent Profile

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

Narcan is a drug marketed by Adapt, Bristol Myers Squibb, and Emergent. and is included in five NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-seven patent family members in fourteen countries.

The generic ingredient in NARCAN 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 Narcan

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

Summary for NARCAN

International Patents:	27
US Patents:	2
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	21
Patent Applications:	4,021
Drug Prices:	Drug price information for NARCAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NARCAN
What excipients (inactive ingredients) are in NARCAN?	NARCAN excipients list
DailyMed Link:	NARCAN at DailyMed

See drug prices for NARCAN

Recent Clinical Trials for NARCAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Johns Hopkins University	Phase 3
Cure Addiction Now	Phase 3
Purdue Pharma LP	Phase 4

See all NARCAN clinical trials

Pharmacology for NARCAN

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Paragraph IV (Patent) Challenges for NARCAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NARCAN	Nasal Spray	naloxone hydrochloride	2 mg/spray	208411	1	2017-12-28
NARCAN	Nasal Spray	naloxone hydrochloride	4 mg/spray	208411	1	2016-07-15

US Patents and Regulatory Information for NARCAN

NARCAN is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adapt	NARCAN	naloxone hydrochloride	INJECTABLE;INJECTION	016636-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Emergent	NARCAN	naloxone hydrochloride	SPRAY, METERED;NASAL	208411-002	Jan 24, 2017		DISCN	Yes	No			Y		Y
Bristol Myers Squibb	NARCAN	naloxone hydrochloride	INJECTABLE;INJECTION	071083-001	Jul 28, 1988		DISCN	No	No
Emergent	NARCAN	naloxone hydrochloride	SPRAY, METERED;NASAL	208411-002	Jan 24, 2017		DISCN	Yes	No			Y		Y

International Patents for NARCAN

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

Country	Patent Number	Title	Estimated Expiration
Spain	2631504
Israel	272294
European Patent Office	3777838
China	106163499	鼻用药物产品及其使用方法 (Nasal drug products and methods of their use)

Supplementary Protection Certificates for NARCAN

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

NARCAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NARCAN

Introduction to NARCAN

NARCAN, a brand name for naloxone, is a crucial opioid antagonist used to reverse opioid overdoses. It is available in various forms, including nasal sprays and auto-injectors, making it a vital tool in the fight against the opioid epidemic.

Market Size and Growth

The naloxone market, which includes NARCAN, is experiencing significant growth driven by several key factors. The global naloxone market is estimated to be valued at USD 1,341.5 million in 2024 and is expected to reach USD 2,683.9 million by 2031, growing at a CAGR of 10.4% from 2024 to 2031[4].

In the U.S., the naloxone market, specifically, is projected to grow from USD 550.4 million in 2024 to USD 1,086.1 million by 2031, with a CAGR of 10.2% during the same period[1].

Drivers of Market Growth

Increasing Prevalence of Opioid Overdoses

The opioid crisis, particularly in the U.S., is a major driver of the naloxone market. With over 130 people dying each day from opioid overdoses in America, the demand for naloxone is on the rise[3].

Government Initiatives and Public Awareness

Government policies and public awareness campaigns aimed at increasing access to naloxone are boosting market growth. Many states and municipalities now recommend or require naloxone to be co-prescribed with opioid prescriptions[4].

Availability of Various Delivery Forms

The availability of naloxone in different delivery forms, such as nasal sprays and auto-injectors, has increased its adoption for emergency treatment. NARCAN Nasal Spray, in particular, has seen significant growth, with revenue increasing from $88.80 million in Q3 2020 to $133.30 million in Q3 2021, a quarter-on-quarter growth of 51.27%[2].

Financial Performance of NARCAN

Revenue Growth

Emergent BioSolutions, the manufacturer of NARCAN Nasal Spray, has reported substantial revenue growth from this product. In 2020, NARCAN Nasal Spray generated revenue of $233.80 million, which increased to $313.70 million in 2021, representing a year-on-year growth of 34.17%[2].

Quarterly Revenue

In Q3 2021, NARCAN Nasal Spray revenue was $133.30 million, contributing 49.27% to the total revenue of Emergent BioSolutions. This represents a significant increase from Q3 2020, when the revenue was $88.80 million[2].

Market Segmentation

Formulation/Route of Administration

The naloxone market is segmented into parenteral, intranasal, and sublingual formulations. The intranasal segment, which includes NARCAN Nasal Spray, is gaining traction due to its ease of use and effectiveness in emergency situations[3].

Sales Channels

Naloxone products, including NARCAN, are sold through various channels such as hospitals, outpatient retail pharmacies, and online pharmacies. The wide distribution network ensures broad availability of these products[3].

Competitive Landscape

The naloxone market is competitive, with several key players. Collaborations among these players are a key strategy to enhance market presence and product distribution. Emergent BioSolutions, with its NARCAN brand, holds a significant position in the market due to its well-established distribution networks and government support[3].

Cost and Accessibility

The cost of NARCAN can vary significantly depending on the brand and payer. For uninsured patients, the mean out-of-pocket costs for NARCAN are generally lower compared to other branded naloxone products like Evzio. For example, the mean OOP cost for NARCAN was $73.62, compared to $1089.17 for Evzio[5].

Regional Market Dynamics

North America, particularly the U.S., holds the largest market share for naloxone due to the high prevalence of opioid abuse and strong government initiatives to combat the opioid crisis. The Asia Pacific region is also emerging as a significant market due to increasing awareness and uptake of naloxone to prevent overdose deaths[3].

Key Takeaways

• The naloxone market, including NARCAN, is expected to grow significantly due to the increasing prevalence of opioid overdoses.
• Government initiatives and public awareness campaigns are driving market growth.
• NARCAN Nasal Spray has seen substantial revenue growth, contributing significantly to Emergent BioSolutions' total revenue.
• The intranasal formulation of naloxone is gaining traction due to its ease of use in emergency situations.
• The market is competitive, with collaborations among key players being a key strategy.

FAQs

1. What is the projected market size of the U.S. naloxone market by 2031? The U.S. naloxone market is expected to reach USD 1,086.1 million by 2031[1].

2. What is the CAGR of the global naloxone market from 2024 to 2031? The global naloxone market is expected to grow at a CAGR of 10.4% from 2024 to 2031[4].

3. How has the revenue of NARCAN Nasal Spray changed from Q3 2020 to Q3 2021? The revenue of NARCAN Nasal Spray increased from $88.80 million in Q3 2020 to $133.30 million in Q3 2021, a quarter-on-quarter growth of 51.27%[2].

4. What are the main drivers of the naloxone market growth? The main drivers include the increasing prevalence of opioid overdoses, government initiatives, and the availability of various delivery forms of naloxone[3][4].

5. How does the cost of NARCAN compare to other branded naloxone products for uninsured patients? For uninsured patients, the mean out-of-pocket cost for NARCAN is generally lower compared to other branded products like Evzio, with NARCAN costing $73.62 on average[5].

Cited Sources:

1. Coherent Market Insights - U.S. naloxone market size and trends.
2. BusinessQuant - Emergent BioSolutions' revenue by product.
3. GlobeNewswire - Insights on the naloxone global market to 2030.
4. Coherent Market Insights - Naloxone market size & share analysis.
5. JAMA Health Forum - Out-of-pocket costs for naloxone by drug brand and payer.