OXYCODONE - Generic Drug Details

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

Oxycodone is the generic ingredient in six branded drugs marketed by Collegium Pharm Inc, Ani Pharms, Avanthi Inc, Dr Reddys Labs Sa, Genus Lifesciences, Lannett Co Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell Molecular, Hikma, Pharm Assoc, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm, Vistapharm Llc, Wes Pharma Inc, Xttrium Labs Inc, Purdue Pharma Lp, Roxane, Zyla, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Strides Pharma, Sun Pharm Inds Inc, and Protega Pharms, and is included in fifty-three NDAs. There are thirty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Oxycodone has twenty-four patent family members in thirteen countries.

There are nineteen drug master file entries for oxycodone. One supplier is listed for this compound. There are four tentative approvals for this compound.

Summary for OXYCODONE

International Patents:	24
US Patents:	34
Tradenames:	6
Applicants:	33
NDAs:	53
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	575
Patent Applications:	6,467
Drug Prices:	Drug price trends for OXYCODONE
Drug Sales Revenues:	Drug sales revenues for OXYCODONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OXYCODONE
What excipients (inactive ingredients) are in OXYCODONE?	OXYCODONE excipients list
DailyMed Link:	OXYCODONE at DailyMed

See drug prices for OXYCODONE

See drug sales revenues for OXYCODONE

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

Constraining patent/regulatory exclusivity:

9,737,530

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 OXYCODONE

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

Sponsor	Phase
Henry Ford Health System	Phase 4
University of Miami	Phase 3
Murdoch Childrens Research Institute	Phase 4

See all OXYCODONE clinical trials

Generic filers with tentative approvals for OXYCODONE

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET, EXTENDED RELEASE; ORAL
		80MG	TABLET, EXTENDED RELEASE; ORAL
		40MG	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 OXYCODONE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for OXYCODONE

Analgesics, Opioid

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for OXYCODONE

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for OXYCODONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XTAMPZA ER	Extended-release Capsules	oxycodone	9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg	208090	1	2017-11-15

US Patents and Regulatory Information for OXYCODONE

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	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-007	Apr 5, 2010		RX	Yes	No	8,894,988		Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-002	Apr 5, 2010		RX	Yes	No	9,763,933		Y
Specgx Llc	ROXICODONE	oxycodone hydrochloride	TABLET;ORAL	021011-003	May 15, 2009	AB	RX	Yes	No

Expired US Patents for OXYCODONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016	9,592,200
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016	9,592,200
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016	8,840,928

International Patents for OXYCODONE

Country	Patent Number	Title	Estimated Expiration
Spain	2653568
European Patent Office	3326617	FORMULATIONS DE MÉDICAMENTS EMPÊCHANT (ABUSE-DETERRENT DRUG FORMULATIONS)
Japan	2017101075	オピオイドおよび他の薬物に関する乱用抑止性の薬学的組成物 (ABUSE-DETERRENT PHARMACEUTICAL COMPOSITIONS OF OPIOIDS AND OTHER DRUGS)

Supplementary Protection Certificates for OXYCODONE

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

OXYCODONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Oxycodone

Introduction

Oxycodone, a potent opioid medication, has been a significant player in the global pharmaceutical market, particularly in the pain management sector. The market dynamics of oxycodone are influenced by a complex interplay of factors, including increasing demand for pain management, regulatory changes, and the ongoing opioid crisis.

Current Market Size and Forecast

As of 2023, the global oxycodone market is valued at approximately $5.11 billion. It is projected to grow substantially, reaching a valuation of $8.92 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 5.7% during the forecast period[1][4].

Historical Growth

From 2018 to 2022, the oxycodone market experienced a CAGR of 4.8%, resulting in a market size of $4.84 billion by the end of 2022. This growth was driven by factors such as improved recognition and treatment of pain, aggressive marketing by pharmaceutical companies, and changes in prescribing practices[1].

Drivers of Market Growth

Several key factors are driving the growth of the oxycodone market:

Increasing Prevalence of Chronic Pain Conditions

The rising incidence of chronic diseases such as cancer, rheumatoid arthritis, lower back pain, and fibromyalgia is a significant driver. These conditions often require effective pain management, for which oxycodone is frequently prescribed[3][4].

Lifestyle Changes and Demographic Factors

Lifestyle changes, including smoking, drinking, obesity, and low physical activity levels, increase the risk of chronic pain diseases. This, in turn, boosts the demand for oxycodone[4].

Development of New Delivery Methods

Market players are focusing on developing new delivery methods for oxycodone, such as patches and nasal sprays. These innovations offer faster onset of action, improved pain relief, and reduced risk of abuse compared to traditional oral formulations[1].

Generic Versions and Patent Expirations

The expiration of patents for branded oxycodone products has led to an increase in generic versions, which contribute significantly to the market's revenue. Generic oxycodone drugs are expected to increase competitive rivalry in the coming years[3][4].

Regulatory and Social Impacts

The oxycodone market is heavily influenced by regulatory interventions and social factors:

Opioid Crisis and Regulatory Scrutiny

The opioid crisis has led to increased scrutiny and regulatory measures aimed at curbing opioid abuse. This has impacted the growth of the oxycodone market, with changing prescribing practices and stricter regulations affecting sales[1].

Economic and Social Costs

The opioid epidemic, of which oxycodone is a part, has significant economic and social costs. In 2020, the opioid epidemic cost the United States nearly $1.5 trillion, up 37% from 2017. This includes costs related to healthcare, lost productivity, and the impact on families and communities[2].

Regional Market Dynamics

The global oxycodone market is geographically diverse, with different regions exhibiting varying growth patterns:

North America

North America is a significant contributor to the global oxycodone market, driven by high prescription rates and the prevalence of chronic pain conditions[4].

Asia Pacific

The Asia Pacific region is anticipated to expand at a significant CAGR during the forecast period. This growth is driven by the rising number of surgical procedures, the increasing need for post-operative care, and the growing burden of chronic pain diseases in countries like India[4].

Competitive Landscape

The oxycodone market is highly fragmented, with numerous notable players operating globally. Key strategies employed by these players include:

Development of New Delivery Methods

Companies are investing in the development of new delivery methods to enhance the efficacy and safety of oxycodone[1].

Generic and Branded Products

Players like Collegium Pharmaceutical and Mundipharma International are focusing on both generic and branded products to capture market share[4].

Impact of Reformulation

The reformulation of OxyContin, a branded version of oxycodone, has had significant consequences. While it reduced access to abusable prescription opioids in the short term, it stimulated the growth of illicit drug markets over a longer time horizon, leading to increased fatal overdoses involving synthetic opioids like fentanyl[5].

Financial Investments and Government Initiatives

To address the opioid epidemic, federal, state, and local governments have increased investments in drug treatment and prevention programs. For instance, the White House announced $1.5 billion in funding for all states and territories to address the epidemic, in addition to the nearly $5.5 billion provided by the American Rescue Plan Act in 2021[2].

Key Takeaways

• The global oxycodone market is projected to reach $8.92 billion by 2033, growing at a CAGR of 5.7% from 2023 to 2033.
• The market is driven by the increasing prevalence of chronic pain conditions, lifestyle changes, and the development of new delivery methods.
• Regulatory scrutiny and the opioid crisis continue to influence market dynamics.
• The Asia Pacific region is expected to witness significant growth due to rising surgical procedures and chronic pain diseases.
• Market players are focusing on generic versions and new delivery methods to enhance market share.

FAQs

Q: What is the current market size of the global oxycodone market? A: As of 2023, the global oxycodone market is valued at approximately $5.11 billion[1].

Q: What is the projected CAGR of the oxycodone market from 2023 to 2033? A: The oxycodone market is expected to grow at a CAGR of 5.7% from 2023 to 2033[1].

Q: What are the main drivers of the oxycodone market growth? A: The main drivers include the increasing prevalence of chronic pain conditions, lifestyle changes, and the development of new delivery methods[3][4].

Q: How has the reformulation of OxyContin impacted the oxycodone market? A: The reformulation reduced access to abusable prescription opioids but stimulated the growth of illicit drug markets, leading to increased fatal overdoses involving synthetic opioids[5].

Q: What initiatives are being taken to address the opioid epidemic? A: Governments are increasing investments in drug treatment and prevention programs, with significant funding announced to address the epidemic[2].

Sources

1. Future Market Insights - Oxycodone Market Size, Trends, Outlook & Forecast 2033
2. U.S. Congress Joint Economic Committee - JEC Analysis Finds Opioid Epidemic Cost U.S. Nearly $1.5 Trillion in 2020
3. BioSpace - Oxycodone Market: Increasing Prevalence of Chronic Diseases and Trauma Conditions Likely to Boost Industry Growth
4. Polaris Market Research - Oxycodone Drugs Market Size, Growth Analysis Report, 2024-2032
5. National Bureau of Economic Research - The Evolving Consequences of OxyContin Reformulation on Drug Overdoses