NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for naloxone hydrochloride; oxycodone hydrochloride and what is the scope of patent protection?

Naloxone hydrochloride; oxycodone hydrochloride is the generic ingredient in one branded drug marketed by Purdue Pharma Lp and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naloxone hydrochloride; oxycodone hydrochloride has one hundred and fifty-one patent family members in forty-one countries.

Summary for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

International Patents:	151
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	51
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
DailyMed Link:	NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

9,522,919

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

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

Sponsor	Phase
Murdoch Childrens Research Institute	Phase 4
Dr. Vince Clinical Research	Phase 1
Ensysce Biosciences	Phase 1

See all NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014		DISCN	Yes	No	9,073,933			Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No	9,073,933			Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014		DISCN	Yes	No	9,522,919		Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014		DISCN	Yes	No	9,522,919		Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No	9,522,919		Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014		DISCN	Yes	No	9,073,933			Y

Expired US Patents for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014	6,696,066
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	8,969,369
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014	9,511,066
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	8,846,091
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	9,056,051
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	9,205,082

International Patents for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	20120046309	PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE
Montenegro	03068	PROCES ZA DOBIJANJE OKSIKODON HIDROHLORIDA SA MANJE OD 25ppm 14-HIDROKSIKODEINONA (PROCES FOR PREPARING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25ppm 14-HYDROXYCODEINONE)
Israel	235298	תהליך להכנת אוקסיקודון הידרוכלוריד המכיל פחות מ-25 חלקים למיליון של 14-הידרואוקסיקודאינון (Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone)
Croatia	P20150358
Malaysia	172063	OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE
Israel	213890	אוקסיקודון הידרוכלוריד המכיל פחות מ-25 חלקים למיליון של 14-הידרואוקסיקודאינון (Oxycodone hydrochloride containing less than 25 ppm 14-hydroxycodeinone)

Supplementary Protection Certificates for NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE

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

NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naloxone Hydrochloride and Oxycodone Hydrochloride

Introduction to Naloxone Hydrochloride and Oxycodone Hydrochloride

Naloxone hydrochloride and oxycodone hydrochloride are two drugs that, although used for different purposes, are intricately linked in the broader context of the opioid crisis.

• Naloxone Hydrochloride: This drug is an opioid antagonist used to reverse opioid overdose. It is crucial in the fight against the opioid epidemic.
• Oxycodone Hydrochloride: This is an opioid analgesic used for pain relief, particularly for chronic pain and post-surgical pain management.

Market Dynamics for Naloxone Hydrochloride

Global Market Size and Growth

The naloxone market is projected to experience significant growth. It 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 compound annual growth rate (CAGR) of 10.4% from 2024 to 2031[1].

Drivers of Market Growth

• Increasing Opioid Overdose Cases: The rising prevalence of opioid overdose cases globally is a major driver. As opioid prescriptions for chronic pain management increase, so do the cases of opioid overdoses, thereby increasing the demand for naloxone[1].
• Government Policies and Public Awareness: Favorable government policies and programs aimed at increasing public awareness and availability of naloxone are also boosting market growth. Many states and municipalities recommend or require naloxone to be co-prescribed with opioid prescriptions[1].
• Healthcare Coverage: Most private and public healthcare plans provide coverage for naloxone, making it more affordable and accessible to users[1].

Regional Market Analysis

• North America: This region represents the largest market for naloxone globally, expected to hold 43.8% of the market share in 2024. The growing epidemic of opioid abuse and rising mortality rates have led to increased government focus and policy changes to expand access to naloxone[1].

Financial Trajectory for Naloxone Hydrochloride

Out-of-Pocket Costs

The financial trajectory of naloxone is influenced by out-of-pocket (OOP) costs, which vary significantly based on insurance status.

• Insured Patients: The mean OOP cost of naloxone decreased by 26% among insured patients from 2014 to 2018[2].
• Uninsured Patients: Conversely, the mean OOP cost increased by 506% among uninsured patients during the same period. For example, the mean OOP cost for Evzio among uninsured patients rose dramatically, highlighting a significant financial barrier for this group[2].

Impact of Brand and Payer

• Brand Variations: Different brands of naloxone, such as Narcan and Evzio, have varying OOP costs. Evzio, in particular, has seen a substantial increase in costs for uninsured patients, making it less accessible[2].
• Payer Influence: The study also highlights that the number of naloxone claims among insured patients began increasing rapidly after 2014, while uninsured patients faced increasing financial impediments[2].

Market Dynamics for Oxycodone Hydrochloride

Global Market Size and Growth

The oxycodone hydrochloride market was valued at US$ 403.9 million in 2023 and is estimated to grow at a CAGR of 4.8% from 2024 to 2034, reaching US$ 675.2 million by 2034[3].

Drivers of Market Growth

• Increasing Surgical Procedures: The rise in the number of surgical procedures, with over 313 million surgeries annually, drives the demand for oxycodone hydrochloride for post-surgical pain management[3].
• Chronic Pain Management: Oxycodone hydrochloride is increasingly prescribed for chronic pain relief, particularly for conditions like cancer, osteoarthritis, and rheumatoid arthritis[3].
• Healthcare Preferences: Healthcare personnel prefer oxycodone hydrochloride for its analgesic and antitussive properties, especially when non-opioid pain medicines are ineffective[3].

Regional Market Analysis

• North America: This region dominates the oxycodone hydrochloride market due to the high prevalence of chronic pain conditions and the increased number of surgical procedures in the U.S.[3].

Financial Trajectory for Oxycodone Hydrochloride

Market Value Forecast

The market value of oxycodone hydrochloride is expected to increase steadily, driven by the growing need for effective pain management solutions. The forecast includes growth in various segments such as controlled-release and immediate-release formulations, as well as different routes of administration like oral and parenteral[3].

Distribution Channels

The distribution of oxycodone hydrochloride is expected to expand through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. This diversification in distribution is likely to make the drug more accessible and contribute to its financial growth[3].

Comparative Analysis

Naloxone vs. Oxycodone Hydrochloride

• Purpose: Naloxone is used to reverse opioid overdoses, while oxycodone hydrochloride is used for pain relief.
• Market Growth: Naloxone has a higher CAGR (10.4%) compared to oxycodone hydrochloride (4.8%), reflecting the urgent need to address the opioid crisis[1][3].
• Regional Dominance: Both markets are dominated by North America, but for different reasons. Naloxone's dominance is due to the opioid epidemic, while oxycodone hydrochloride's is due to the high prevalence of chronic pain conditions and surgical procedures[1][3].

Key Challenges and Opportunities

Naloxone Hydrochloride

• Challenges: Financial barriers, particularly for uninsured patients, and the need for continued government support and public awareness campaigns.
• Opportunities: Expanding healthcare coverage and reducing OOP costs can increase accessibility and drive market growth[1][2].

Oxycodone Hydrochloride

• Challenges: The risk of opioid abuse and the need for balanced prescribing practices to avoid contributing to the opioid crisis.
• Opportunities: Expanding into unexplored geographies and increasing awareness about the benefits of oxycodone hydrochloride for pain relief post-surgery and for chronic ailments[3].

Conclusion

The markets for naloxone hydrochloride and oxycodone hydrochloride are driven by distinct yet interconnected factors. Naloxone's growth is fueled by the urgent need to combat the opioid crisis, while oxycodone hydrochloride's growth is driven by the increasing demand for effective pain management solutions.

Key Takeaways

• Naloxone Hydrochloride:
  • Expected to grow at a CAGR of 10.4% from 2024 to 2031.
  • Driven by increasing opioid overdose cases and favorable government policies.
  • Financial barriers, especially for uninsured patients, need to be addressed.
• Oxycodone Hydrochloride:
  • Expected to grow at a CAGR of 4.8% from 2024 to 2034.
  • Driven by the rise in surgical procedures and chronic pain management needs.
  • Dominated by the North American market due to high prevalence of chronic pain conditions.

FAQs

1. What is the primary use of naloxone hydrochloride? Naloxone hydrochloride is primarily used as an antidote to reverse opioid overdose.

2. How is the naloxone market expected to grow? The naloxone market is expected to grow at a CAGR of 10.4% from 2024 to 2031, reaching USD 2,683.9 million by 2031[1].

3. What drives the demand for oxycodone hydrochloride? The demand for oxycodone hydrochloride is driven by the increasing number of surgical procedures and the need for effective chronic pain management[3].

4. How do out-of-pocket costs affect naloxone accessibility? Out-of-pocket costs significantly affect naloxone accessibility, particularly for uninsured patients, who have seen a 506% increase in OOP costs from 2014 to 2018[2].

5. Which region dominates the oxycodone hydrochloride market? North America dominates the oxycodone hydrochloride market due to the high prevalence of chronic pain conditions and surgical procedures in the U.S.[3].

Sources

1. Coherent Market Insights - Naloxone Market Size & Share Analysis - Industry Research Report
2. PubMed - Trends in Out-of-Pocket Costs for Naloxone by Drug Brand and Payer
3. Transparency Market Research - Oxycodone Hydrochloride Market Size & Share, Outlook, 2034
4. Coherent Market Insights - US Naloxone Market Size and Trends - Coherent Market Insights
5. PMC - Investigating the complexity of naloxone distribution: Which policies ...