Naltrexone hydrochloride; oxycodone hydrochloride - Generic Drug Details

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

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

Naltrexone hydrochloride; oxycodone hydrochloride has sixteen patent family members in twelve countries.

Summary for naltrexone hydrochloride; oxycodone hydrochloride

International Patents:	16
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	18
DailyMed Link:	naltrexone hydrochloride; oxycodone hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for naltrexone hydrochloride; oxycodone hydrochloride

Constraining patent/regulatory exclusivity:

8,685,443

Dosage:

CAPSULE, 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 naltrexone hydrochloride; oxycodone hydrochloride

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

Sponsor	Phase
Quotient Sciences	Phase 1
New York State Psychiatric Institute	Phase 1/Phase 2
Clinilabs, Inc.	Phase 1/Phase 2

See all naltrexone hydrochloride; oxycodone hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for naltrexone hydrochloride; oxycodone hydrochloride

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for naltrexone 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
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-002	Aug 19, 2016		DISCN	No	No	7,815,934		Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-003	Aug 19, 2016		DISCN	No	No	8,685,443
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-001	Aug 19, 2016		DISCN	No	No	8,685,443
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016		DISCN	No	No	8,685,443
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-005	Aug 19, 2016		DISCN	No	No	8,685,443
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-006	Aug 19, 2016		DISCN	No	No	7,815,934		Y

International Patents for naltrexone hydrochloride; oxycodone hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2422772	Séquestration de sous-unité et compositions et procédés associés (Sequestering subunit and related compositions and methods)
Spain	2677769
World Intellectual Property Organization (WIPO)	2004026283
Canada	2499550	SOUS-UNITE DE SEQUESTRATION ET COMPOSITIONS ET PROCEDES ASSOCIES (SEQUESTERING SUBUNIT AND RELATED COMPOSITIONS AND METHODS)
Australia	2003270778	SEQUESTERING SUBUNIT AND RELATED COMPOSITIONS AND METOHDS
China	1703200	Sequestering subunit and related compositions and methods

Supplementary Protection Certificates for naltrexone hydrochloride; oxycodone hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	2017/059	Ireland		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456	LUC00054	Luxembourg		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	SPC/GB17/078	United Kingdom		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
2316456	1790064-8	Sweden		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330

Naltrexone hydrochloride; oxycodone hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naltrexone Hydrochloride and Oxycodone Hydrochloride

Introduction

The pharmaceutical market for naltrexone hydrochloride and oxycodone hydrochloride is driven by distinct yet interconnected factors, including the rise in alcohol and opioid dependency, advancements in abuse-deterrent formulations, and the increasing need for effective pain management.

Naltrexone Hydrochloride Market Dynamics

Market Drivers

• Increasing Alcohol Dependency: The global naltrexone HCL market is primarily driven by the growing cases of alcohol dependence. According to the 2015 National Survey on Drug Use and Health (NSDUH), 7% of the population was engaged in heavy alcohol use, creating a significant demand for naltrexone HCL[1].

Applications

• Treatment of Alcohol Dependence: Naltrexone HCL is widely used to treat alcohol dependence due to its ability to block the subjective effects of opioids and reduce the craving for alcohol.

Competitive Landscape

• Key Market Players: Companies such as IVAX, Sanofi, Mallinckrodt Pharmaceuticals, and Teva Pharmaceutical Industries Ltd. are key players in the naltrexone HCL market. These companies are focused on expanding their market presence and developing new formulations[1].

Challenges

• Side Effects: Despite its efficacy, naltrexone HCL is associated with side effects such as nausea, which can restrict market growth. Managing these side effects is crucial for maintaining patient compliance and market expansion[1].

Oxycodone Hydrochloride Market Dynamics

Market Drivers

• Rise in Surgical Procedures: The oxycodone hydrochloride market is driven by the increasing number of surgical procedures worldwide. With 313 million surgical procedures annually, the demand for oxycodone hydrochloride as a post-surgical pain relief medication is on the rise[3].
• Chronic Pain Management: The need for enhanced pain management in chronic diseases such as cancer, osteoarthritis, and rheumatoid arthritis also fuels the market growth[3].

Applications

• Pain Relief: Oxycodone hydrochloride is prescribed for moderate-to-severe chronic pain and is particularly recommended for patients who do not respond to non-opioid pain medicines[3].

Abuse-Deterrent Formulations

• TROXYCA ER: The approval of TROXYCA ER, which combines oxycodone hydrochloride with naltrexone hydrochloride, has introduced abuse-deterrent properties. This formulation is designed to release naltrexone when the pellets are crushed, counteracting the effects of oxycodone and reducing the potential for abuse[4].

Competitive Landscape

• Leading Regions: North America dominates the oxycodone hydrochloride market due to the high prevalence of chronic pain conditions in the U.S. and Canada. Other regions, including Europe and Asia Pacific, are also significant markets[3].

Challenges

• Side Effects and Abuse Potential: Oxycodone hydrochloride is associated with side effects such as constipation, sedation, and respiratory depression. The abuse potential of opioids is a significant concern, despite advancements in abuse-deterrent formulations[3][4].

Financial Trajectory

Naltrexone Hydrochloride

• Market Growth: The global naltrexone HCL market is expected to grow driven by the increasing prevalence of alcohol dependency. However, the growth may be tempered by the side effects associated with the drug[1].

Oxycodone Hydrochloride

• 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% to reach US$ 675.2 million by 2034. This growth is fueled by the rising number of surgical procedures and the increasing need for chronic pain management[3].

Regional Analysis

Naltrexone Hydrochloride

• Global Market: The naltrexone HCL market is analyzed across various regions, with a focus on understanding the competitive environment and market opportunities. Key regions include North America, Europe, and Asia Pacific[1].

Oxycodone Hydrochloride

• North America: This region dominates the oxycodone hydrochloride market due to the high incidence of chronic pain conditions and surgical procedures. Other significant regions include Europe and the Asia Pacific[3].

Key Market Players and Strategies

Naltrexone Hydrochloride

• Competitive Outlook: Key players in the naltrexone HCL market are focused on expanding their product portfolios and geographical reach. Strategies include developing new formulations and enhancing distribution channels[1].

Oxycodone Hydrochloride

• Innovative Formulations: Companies like Pfizer are developing innovative abuse-deterrent formulations such as TROXYCA ER. These formulations aim to reduce the abuse potential of oxycodone while maintaining its therapeutic efficacy[4].

Clinical Developments and Research

Naltrexone Hydrochloride

• Current Research: Ongoing research focuses on the clinical efficacy and safety of naltrexone HCL in treating alcohol dependence. Studies also explore its potential in treating other conditions, such as opioid dependence[1].

Oxycodone Hydrochloride

• Abuse-Deterrent Studies: Clinical studies are continually being conducted to evaluate the abuse-deterrent properties of new formulations. For example, TROXYCA ER has undergone extensive testing to demonstrate its abuse-deterrent features[4].

Regulatory Environment

Naltrexone Hydrochloride

• Regulatory Approvals: Naltrexone HCL has received regulatory approvals for its use in treating alcohol dependence. Regulatory bodies continue to monitor its safety and efficacy[1].

Oxycodone Hydrochloride

• FDA Approvals: The FDA has approved several oxycodone hydrochloride formulations, including TROXYCA ER, which has abuse-deterrent properties. Regulatory approvals are crucial for market entry and expansion[4].

Market Opportunities and Challenges

Naltrexone Hydrochloride

• Opportunities: The growing need for alcohol dependence treatment presents significant market opportunities. However, managing side effects and expanding geographical reach are key challenges[1].

Oxycodone Hydrochloride

• Opportunities: The increasing demand for post-surgical pain relief and chronic pain management offers substantial market opportunities. Challenges include addressing the abuse potential and side effects associated with oxycodone hydrochloride[3].

Future Outlook

Naltrexone Hydrochloride

• Growth Prospects: The naltrexone HCL market is expected to grow as alcohol dependency rates continue to rise. Innovations in formulations and delivery methods will be crucial for sustained growth[1].

Oxycodone Hydrochloride

• Growth Prospects: The oxycodone hydrochloride market is poised for significant growth driven by the increasing need for pain management. Advancements in abuse-deterrent formulations will play a critical role in shaping the market's future[3].

Key Takeaways

• The naltrexone HCL market is driven by the increasing prevalence of alcohol dependency and is expected to grow despite challenges related to side effects.
• The oxycodone hydrochloride market is fueled by the rise in surgical procedures and the need for chronic pain management, with a focus on abuse-deterrent formulations.
• Key market players are investing in innovative formulations and expanding their geographical reach.
• Regulatory approvals and ongoing clinical research are crucial for market growth and safety.

FAQs

What is the primary use of naltrexone hydrochloride?

Naltrexone hydrochloride is primarily used to treat alcohol dependence by blocking the subjective effects of opioids and reducing the craving for alcohol.

How does TROXYCA ER differ from other oxycodone formulations?

TROXYCA ER combines oxycodone hydrochloride with naltrexone hydrochloride and has abuse-deterrent properties, releasing naltrexone when the pellets are crushed to counteract the effects of oxycodone.

What are the key drivers of the oxycodone hydrochloride market?

The oxycodone hydrochloride market is driven by the increasing number of surgical procedures and the growing need for chronic pain management.

Which region dominates the oxycodone hydrochloride market?

North America dominates the oxycodone hydrochloride market due to the high incidence of chronic pain conditions and surgical procedures in the U.S. and Canada.

What are the potential side effects of naltrexone hydrochloride and oxycodone hydrochloride?

Naltrexone hydrochloride is associated with side effects such as nausea, while oxycodone hydrochloride can cause constipation, sedation, and respiratory depression.

Sources

1. Allied Market Research. Naltrexone HCL Market.
2. Anesthesiology. Abuse-deterrent Opioid Formulations.
3. Transparency Market Research. Oxycodone Hydrochloride Market Size & Share, Outlook, 2034.
4. Pfizer. FDA Approves TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules CII with Abuse-Deterrent Properties for the Management of Pain.