ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for acetaminophen; oxycodone hydrochloride and what is the scope of freedom to operate?

Acetaminophen; oxycodone hydrochloride is the generic ingredient in twelve branded drugs marketed by Actavis Elizabeth, Barr, Duramed Pharms Barr, Halsey, Mallinckrodt, Mutual Pharm, Vintage Pharms, Vintage Pharms Llc, Watson Labs, Roxane, Janssen Pharms, Ortho Mcneil Pharm, Abhai Llc, Mikart, Nostrum Labs Inc, Specgx Llc, Endo Operations, Hikma, Mallinckrodt Inc, Bristol Myers Squibb, Alvogen, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell, Dr Reddys Labs Sa, Elite Labs Inc, Epic Pharma Llc, Granules, Lannett Co Inc, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sanaluz, Sun Pharm Inds Inc, and Wes Pharma Inc, and is included in sixty-six NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetaminophen; oxycodone hydrochloride has thirty-one patent family members in thirteen countries.

Thirty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

International Patents:	31
US Patents:	12
Tradenames:	12
Applicants:	37
NDAs:	66
Finished Product Suppliers / Packagers:	35
Clinical Trials:	143
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
DailyMed Link:	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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

Sponsor	Phase
Henry Ford Health System	Phase 4
Jessyka Lighthall	Phase 3
Universidad Simón Bolívar	Phase 3

See all ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		325MG; 7.5MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

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

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	PERCOCET	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040330-001	Jun 25, 1999	AA	RX	No	Yes
Nostrum Labs Inc	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	SOLUTION;ORAL	201448-001	Aug 26, 2021	AA	RX	No	No
Nesher Pharms	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	210079-004	Dec 28, 2017		DISCN	No	No

Expired US Patents for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014	6,488,962

International Patents for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1152469	GASTRIC RETENTIVE EXTENDED-RELEASE DOSAGE FORMS COMPRISING COMBINATIONS OF A NON-OPIOID ANALGESIC AND AN OPIOID ANALGESIC
World Intellectual Property Organization (WIPO)	2011087765
Mexico	PA04003930	FORMA DE DOSIFICACION ORAL RETENTIVA GASTRICA CON LIBERACION LIMITADA DE MEDICAMENTO EN EL TRACTO GASTROINTESTINAL INFERIOR. (GASTRIC RETENTIVE ORAL DOSAGE FORM WITH RESTRICTED DRUG RELEASE IN THE LOWER GASTROINTESTINAL TRACT.)

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxycodone Hydrochloride and Acetaminophen Combination

Market Overview

The market for oxycodone hydrochloride, often combined with acetaminophen, is poised for significant growth driven by several key factors.

Market Size and Growth

As of 2023, the oxycodone hydrochloride market was valued at approximately USD 410.9 million[3][1].

• This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.49% to 4.8% from 2024 to 2030 or 2034, respectively, reaching nearly USD 559.1 million by 2030 or USD 675.2 million by 2034[1][3].

Key Drivers

Increasing Prevalence of Chronic Pain

The rising incidence of chronic pain conditions such as cancer, back pain, and arthritis significantly drives the demand for oxycodone hydrochloride. As the global population ages, the prevalence of these chronic diseases increases, creating a steady demand for effective long-term pain management solutions[1][3].

Advancements in Pain Management

Advancements in pain management practices and the development of new formulations, such as controlled-release and immediate-release forms, contribute to the market's growth. These advancements help in providing consistent and reliable pain relief for extended periods[1][3].

Robust Healthcare Infrastructure

North America, which dominates the market, benefits from a robust healthcare infrastructure. This infrastructure supports the widespread use of oxycodone hydrochloride for pain management, particularly for chronic conditions, post-surgical pain, and cancer pain[1][3].

Regional Insights

North America

North America leads the oxycodone hydrochloride market due to high rates of chronic pain conditions and advanced pain management practices. The U.S. is a significant contributor, with a large number of patients suffering from conditions like cancer, osteoarthritis, and rheumatoid arthritis[1][3].

Europe and Asia Pacific

Europe and the Asia Pacific region also show promising growth, driven by increasing chronic pain prevalence and improvements in healthcare infrastructure. Countries like Germany, the U.K., France, and China are key markets within these regions[1][3].

Distribution Channels

Hospital Pharmacies

Hospital pharmacies are a major distribution channel for oxycodone hydrochloride, especially for post-operative pain management and treatment of chronic conditions. Retail and online pharmacies also play significant roles, offering convenience and accessibility to patients[1][3].

Formulations and Applications

Controlled-Release and Immediate-Release

Oxycodone hydrochloride is available in both controlled-release and immediate-release formulations. Controlled-release formulations are particularly popular for chronic pain management due to their ability to provide consistent pain relief over an extended period[1][3].

Combination with Acetaminophen

The combination of oxycodone hydrochloride with acetaminophen, as seen in medications like Percocet, enhances pain-relieving capabilities and introduces fever-reducing properties. This combination allows for lower doses of oxycodone, potentially reducing the risk of dependency and side effects[2][5].

Challenges and Opportunities

Opioid Abuse and Regulatory Efforts

Despite the growth, the market faces challenges related to opioid abuse. Regulatory efforts to enhance drug safety and reduce misuse are ongoing. Companies are also focusing on developing safer formulations and educating healthcare providers and patients about the proper use of these medications[1][3].

Drug Shortages

Occasional drug shortages, as reported for oxycodone and acetaminophen combination tablets, can impact market dynamics. However, manufacturers are working to address these shortages and ensure a stable supply chain[4].

Market Attractiveness Analysis

The market attractiveness analysis highlights the potential for growth in various regions and distribution channels. The increasing demand for effective pain management solutions, coupled with advancements in formulations and distribution, makes the oxycodone hydrochloride market highly attractive for investors and pharmaceutical companies[1][3].

Expert Insights

"Oxycodone hydrochloride, especially in its extended-release formulations, is widely prescribed to treat chronic pain, providing consistent and reliable relief for long periods," notes a market analyst. "The combination with acetaminophen further enhances its pain-relieving capabilities and reduces the risk of dependency and side effects"[2].

Statistics and Trends

• 129 million people in the U.S. have at least one major chronic disease, such as heart disease, cancer, diabetes, or hypertension, driving the demand for oxycodone hydrochloride[3].
• 39% of adults in the U.S. experience back pain, the most common type of pain, further fueling the market growth[3].

Key Takeaways

• The oxycodone hydrochloride market is expected to grow significantly due to the increasing prevalence of chronic pain and advancements in pain management.
• North America dominates the market, driven by a robust healthcare infrastructure and high rates of chronic pain conditions.
• The combination with acetaminophen enhances pain relief and reduces the risk of dependency and side effects.
• Regulatory efforts and drug safety measures are crucial in addressing opioid abuse challenges.
• Market attractiveness analysis indicates high potential for growth in various regions and distribution channels.

Frequently Asked Questions (FAQs)

1. What is the current market size of the oxycodone hydrochloride market?

The oxycodone hydrochloride market was valued at approximately USD 410.9 million in 2023[3].

2. What is the projected growth rate of the oxycodone hydrochloride market?

The market is expected to grow at a CAGR of 4.49% to 4.8% from 2024 to 2030 or 2034[1][3].

3. Which region dominates the oxycodone hydrochloride market?

North America dominates the oxycodone hydrochloride market due to high rates of chronic pain conditions and advanced pain management practices[1][3].

4. What are the key drivers of the oxycodone hydrochloride market?

The increasing prevalence of chronic pain, advancements in pain management, and a robust healthcare infrastructure are key drivers of the market[1][3].

5. How does the combination with acetaminophen impact the market?

The combination with acetaminophen enhances pain-relieving capabilities, introduces fever-reducing properties, and allows for lower doses of oxycodone, potentially reducing the risk of dependency and side effects[2][5].

Cited Sources:

1. Transparency Market Research - Oxycodone Hydrochloride Market Size & Share, Outlook, 2034
2. Opiates.com - Oxycodone vs. Percocet
3. Maximize Market Research - Oxycodone Hydrochloride Market: Size, Dynamics and Forecast
4. American Society of Health-System Pharmacists (ASHP) - Oxycodone Hydrochloride and Acetaminophen Tablets
5. Mayo Clinic - Oxycodone and acetaminophen (oral route)