OXYCODONE HYDROCHLORIDE - Generic Drug Details

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

Oxycodone hydrochloride is the generic ingredient in five branded drugs marketed by 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, Hibrow Hlthcare, Hikma, Pharm Assoc, Pharmobedient, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm Llc, Purdue Pharma Lp, Roxane, Zyla, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Strides Pharma Intl, Sun Pharm Inds Inc, and Protega Pharms, and is included in fifty-two NDAs. There are twenty-three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxycodone hydrochloride has four hundred and eight patent family members in forty-eight countries.

There are twelve drug master file entries for oxycodone hydrochloride. Forty suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for OXYCODONE HYDROCHLORIDE

International Patents:	408
US Patents:	23
Tradenames:	5
Applicants:	31
NDAs:	52
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	628
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OXYCODONE HYDROCHLORIDE
What excipients (inactive ingredients) are in OXYCODONE HYDROCHLORIDE?	OXYCODONE HYDROCHLORIDE excipients list
DailyMed Link:	OXYCODONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for OXYCODONE HYDROCHLORIDE

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

Sponsor	Phase
Christopher D. Verrico	PHASE1
Baylor College of Medicine	PHASE1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE3

See all OXYCODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE

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 HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for OXYCODONE HYDROCHLORIDE

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for OXYCODONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OXAYDO	Tablets	oxycodone hydrochloride	5 mg and 7.5 mg	202080	1	2012-02-07
OXYCONTIN	Extended-release Tablets	oxycodone hydrochloride	20 mg	022272	2	2010-10-29
OXYCONTIN	Extended-release Tablets	oxycodone hydrochloride	15 mg	022272	1	2010-10-28
OXYCONTIN	Extended-release Tablets	oxycodone hydrochloride	10 mg	022272	1	2010-10-25
OXYCONTIN	Extended-release Tablets	oxycodone hydrochloride	30 mg, 60 mg and 80 mg	022272	1	2010-10-18
OXYCONTIN	Extended-release Tablets	oxycodone hydrochloride	40 mg	022272	1	2010-10-04

US Patents and Regulatory Information for 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	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010		RX	Yes	No	9,492,393
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010		RX	Yes	No	9,763,933		Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-003	Apr 5, 2010		RX	Yes	No	12,280,152		Y

Expired US Patents for OXYCODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-002	Apr 5, 2010	10,696,684
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-005	Apr 5, 2010	7,674,799
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010	9,675,610

International Patents for OXYCODONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Mexico	360849	FORMAS DE DOSIFICACION FARMACEUTICA. (TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC.)
Poland	2082742
Tunisia	2009000059	FORMES DE DOSAGE PHARMACEUTIQUES ORALES ANTI-MANIPULATION CONTENANT UN ANALGESIQUE OPIOIDE

Supplementary Protection Certificates for 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

Market Dynamics and Financial Trajectory for Oxycodone Hydrochloride

Last updated: July 27, 2025

Introduction

Oxycodone hydrochloride, a potent opioid analgesic, has long occupied a significant position within the pharmaceutical landscape due to its efficacy in managing moderate to severe pain. Its impact extends beyond clinical applications, influencing market dynamics, regulatory frameworks, and financial outcomes. This analysis explores the current market forces, competitive landscape, regulatory challenges, and forecasted financial trajectory for oxycodone hydrochloride, offering critical insights for stakeholders and investors.

Market Overview

Global Market Size and Growth

The global opioid analgesics market, valued at approximately USD 8 billion in 2022, is projected to grow at a CAGR of roughly 4.5% from 2023 to 2030, driven by increasing chronic pain prevalence and advancements in pain management modalities [1]. Oxycodone hydrochloride, serving as a primary component in this sphere, constitutes a significant segment within these figures.

Key Market Players

Leading pharmaceutical companies, including Purdue Pharma, Teva Pharmaceuticals, and Mallinckrodt Pharmaceuticals, dominate oxycodone production and distribution. Purdue’s reformulation of OxyContin in 2010, incorporating tamper-resistant features, marked a pivotal shift in the market, affecting both demand and regulatory perceptions.

Application and Demand Drivers

Oxycodone’s primary application in pain management, especially for cancer and post-surgical pain, sustains steady demand. Nonetheless, the growing emphasis on opioid stewardship and alternative therapies influences prescribing patterns. The opioid crisis has caused healthcare providers and regulators to impose stricter controls, influencing market volume and access.

Regulatory and Legal Landscape

Regulatory Environment

Oxycodone hydrochloride’s approval process is governed by stringent agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Post-2010 opioid epidemic concerns led to the enforcement of robust regulatory measures, including prescription monitoring programs and distribution controls [2].

Legal Challenges and Litigation

Pharmaceutical manufacturers face extensive litigation related to opioid marketing and misuse. Notably, Purdue Pharma filed for bankruptcy amidst thousands of lawsuits. Such legal disputes can influence market confidence, production costs, and long-term financial planning.

Market Challenges and Risks

• Regulatory Constraints: Increasing restrictions on prescription opioid distributions may reduce market size.
• Public Perception: Rising awareness of opioid addiction risks deters overuse and impacts sales.
• Supply Chain Disruptions: Pandemics, geopolitical issues, and manufacturing complexities threaten consistent supply.
• Generic Competition: Expiry of patents and emergence of generics exert downward pressure on pricing and profitability.

Financial Trajectory and Future Outlook

Revenue Trends

Despite challenges, oxycodone hydrochloride remains financially significant, with revenues sustaining approximately USD 2–3 billion annually in North America alone. Market resilience stems from its entrenched use in pain management, especially where alternative analgesics are insufficient.

Pricing and Margins

Pricing strategies are under pressure; regulatory and legal risks prompt manufacturers to adopt stringent control measures, often leading to increased compliance costs. Gross margins for proprietary formulations tend to be higher compared to generics, which are sensitive to price erosion.

Innovation and Diversification

Financial prospects are increasingly linked to the development of abuse-deterrent formulations and alternative pain therapies. Companies investing in formulation innovations aim to mitigate misuse while capturing market share, potentially leading to sustained revenues.

Forecasted Growth

While the overall opioid market is expected to grow modestly, the specific trajectory for oxycodone hydrochloride is cautious. The emphasis on responsible prescribing and alternative modalities suggests a plateauing or slight decline in usage. However, specialized formulations and geographic expansion could offset some reductions.

Regional Market Dynamics

North America

Dominant in oxycodone consumption, North America accounts for approximately 80% of demand. Regulatory crackdowns and litigation risks have created market volatility, but high pain management needs sustain its financial importance [3].

European and Asian Markets

Growth prospects are moderate due to diverse regulatory landscapes and emerging opioid markets. Access and regulatory approval processes remain barriers, but increasing healthcare infrastructure could bolster future demand.

Legal and Ethical Considerations

Manufacturers and distributors bear substantial legal responsibilities. Ensuring compliance and ethical marketing are critical to mitigate litigation costs and protect brand reputation. The recent trend emphasizes transparent reporting and responsible opioid stewardship.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Focus on developing abuse-deterrent formulations, diversify into non-opioid pain therapies, and navigate complex regulatory environments.
• Investors: Prioritize companies with robust legal risk management, innovative pipeline, and geographical diversification.
• Healthcare Providers: Balance effective pain management with regulatory compliance and patient safety, influencing market demand.

Conclusion

Oxycodone hydrochloride remains a financially significant but increasingly scrutinized segment of the pharmaceutical industry. Market dynamics are transitioning due to regulatory pressures, litigation risks, and evolving prescribing practices. While growth prospects are moderated, innovation in formulations and expanding markets in emerging regions could offer sustained revenue streams.

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Key Takeaways

• The global oxycodone hydrochloride market is substantial, but growth is tempered by regulatory and legal challenges.
• Legal disputes and opioid stewardship efforts influence market stability and financial performance.
• Development of abuse-deterrent formulations presents a strategic avenue for maintaining market share.
• North America dominates demand, but future growth may increasingly depend on emerging markets.
• Stakeholders must balance commercial objectives with regulatory compliance and ethical practices.

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FAQs

1. How have recent regulations impacted the oxycodone hydrochloride market?
Regulations have significantly limited prescribing and distribution channels, leading to decreased market volume in some regions. Prescription monitoring programs and tighter controls aim to mitigate misuse, impacting revenue streams for manufacturers.

2. What role does patent expiration play in oxycodone hydrochloride’s market dynamics?
Patent expirations allow generic manufacturers to enter the market, driving down prices and overall profitability for original formulators. This intensifies price competition but also diversifies available products.

3. Are there ongoing innovations that could reshape the oxycodone market?
Yes. Development of abuse-deterrent formulations and non-opioid alternatives offers potential to sustain demand while addressing safety concerns. However, regulatory approval for new formulations remains rigorous.

4. How does the legal environment influence company strategies?
Legal challenges, especially related to litigation and settlement costs, prompt companies to implement stricter compliance programs, re-evaluate marketing practices, and invest in safer product development.

5. What are the prospects for oxycodone hydrochloride in emerging markets?
Opportunities exist as healthcare infrastructure improves and demand for pain management rises. Nonetheless, regulatory hurdles and cultural attitudes towards opioids may delay expansion.

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References

[1] MarketResearch.com, "Global Opioid Analgesics Market," 2022.
[2] FDA, "Opioid Prescribing Guidance," 2021.
[3] IQVIA, "Pharmaceutical Market Insights," 2022.