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, 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-three NDAs. There are thirty-five 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:	35
Tradenames:	6
Applicants:	32
NDAs:	53
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	627
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

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
Baylor College of Medicine	PHASE1
Christopher D. Verrico	PHASE1
Senthil Sadhasivam	PHASE3

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	022272-005	Apr 5, 2010		RX	Yes	Yes			Y
Rhodes Pharms	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	091490-002	Mar 9, 2011	AB	RX	No	No
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-001	Apr 26, 2016		RX	Yes	No			Y
Novel Labs Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	204021-005	Jun 12, 2017		DISCN	No	No
Aurolife Pharma Llc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	202160-001	Nov 19, 2012	AB	RX	No	No
Actavis Elizabeth	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	076636-002	Feb 6, 2004		DISCN	No	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	208090-005	Apr 26, 2016
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-001	Apr 26, 2016
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016

International Patents for OXYCODONE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1765292	FORMULATIONS DE PRÉVENTION DES ABUS (ABUSE-DETERRENT DRUG FORMULATIONS)
Japan	2006500426
Japan	2009298822	ABUSE-DETERRENT PHARMACEUTICAL COMPOSITION ON OPIOID AND OTHER DRUG
Canada	2569958
Japan	4694207
Japan	2015166402	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

Market Dynamics and Financial Trajectory for Oxycodone

Last updated: July 28, 2025

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Introduction

Oxycodone, a potent semi-synthetic opioid analgesic, has played a pivotal role in pain management for decades. It belongs to a class of drugs that, while highly effective for acute and chronic pain, have also become emblematic of the opioid epidemic driven by misuse, dependence, and regulatory scrutiny. As the landscape of pain treatment evolves amidst heightened awareness of opioid-related risks, understanding oxycodone's market dynamics and financial trajectory becomes critical for stakeholders—pharmaceutical companies, healthcare providers, regulators, and investors.

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Historical Context and Market Penetration

Since its FDA approval in the 1930s and subsequent introduction in the 1990s, oxycodone has seen widespread adoption globally, especially in the United States, which historically accounts for over 80% of the opioid market. Its availability in formulations like Percocet (with acetaminophen) and OxyContin (extended-release) propelled its dominance in pain management, particularly for moderate to severe pain [1].

OxyContin, introduced in 1996 by Purdue Pharma, marked a significant breakthrough, capturing a substantial market share due to its perceived lower addiction potential and extended dosing interval. This innovation spurred a dramatic rise in prescriptions, with annual sales peaking in the late 2010s at over $3 billion in the U.S. alone [2].

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Market Dynamics

1. Regulatory Environment and Legal Challenges

The regulatory landscape significantly influences oxycodone’s market trajectory. In response to the opioid crisis, authorities such as the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA) have implemented measures:

• Stricter prescribing guidelines and dosage limits.
• Rescheduling of certain formulations to tighter control schedules.
• Crackdowns on improper marketing and distribution.

These measures have led to declining prescription volumes, with data indicating a 40-60% decrease in oxycodone prescribing in the U.S. from 2016 to 2021 [3].

Legal actions against Purdue Pharma, including the 2021 bankruptcy settlement and lawsuits demanding accountability for opioid epidemic contributions, also impact market perceptions and strategic decisions for pharmaceutical companies involved.

2. Market Saturation and Shift Toward Alternatives

Pharyngeal overprescription and growing awareness of addiction risks have prompted a decline in oxycodone demand, replaced increasingly by abuse-deterrent formulations and alternative pain management modalities such as non-opioid analgesics, nerve blocks, and integrative therapies.

However, despite regulatory controls, oxycodone remains a crucial analgesic, especially for patients with refractory pain where alternatives are less effective. Its role persists, albeit diminished relative to prior decades.

3. Emergence of Abuse-Deterrent Formulations (ADFs)

Pharmaceutical innovation focused on curbing abuse has led to the development of abuse-deterrent oxycodone formulations. ADFs—such as reformulated OxyContin—incorporate physical and chemical barriers to crushing and snorting [4].

While these formulations have shown mixed effectiveness in curbing misuse, their market share has increased, influencing both sales and regulatory approval processes.

4. Global and Regional Market Variability

While the U.S. dominates the oxycodone market, other regions such as Europe, Canada, and Australia exhibit varying prescribing trends driven by national regulations and healthcare practices.

In emerging markets, access remains limited due to regulatory restrictions, supply chain challenges, and economic factors, constraining market growth outside Western nations.

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Financial Trajectory of Oxycodone

1. Revenue Trends

Between 2000 and 2015, oxycodone revenues experienced exponential growth, peaking in the U.S. at over $3 billion annually. The subsequent decline from 2016 onward aligns with regulatory measures and reduction in prescriptions [2].

Major pharmaceutical firms such as Purdue Pharma, and later Teva Pharmaceuticals, have reported revenues associated with oxycodone products. For instance, Purdue’s sales estimates for OxyContin and related formulations reached billions annually before the downturn.

2. Impact of Litigation and Settlement Costs

Legal settlements have introduced significant financial liabilities. Purdue Pharma’s bankruptcy in 2021, coupled with multi-billion-dollar settlements allocated to address opioid-related damages, underlines the considerable financial exposure tied to oxycodone products ([5]).

Other manufacturers face litigations, potential penalties, and reputational damage, which influence future revenue streams and R&D investments.

3. Market Outlook and Future Revenue Streams

Given the entrenched role of oxycodone in pain management, especially for acute and cancer-related pain, a complete market exit is unlikely. Instead, revenue streams are expected to shift towards:

• Development and adoption of abuse-deterrent formulations.
• Expanded use of combination products with lower abuse potential.
• Transition toward formulations intended for specific patient populations, such as oncology.

However, growth prospects are constrained by intensifying regulatory restrictions, public perception, and competition from non-opioid analgesics.

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Key Factors Shaping Future Market and Financial Trends

• Regulatory Stringency: Future policies may further limit prescribing, influencing market volume.
• Public Health Initiatives: Enhanced awareness campaigns and prescription monitoring programs will adapt prescribing behaviors.
• Pharmaceutical Innovation: Development of novel formulations—such as implants or non-addictive analgesics—may mitigate declines.
• Litigation and Compensation: Financial liabilities from lawsuits may deter investments or redirect R&D priorities.
• Global Market Expansion: Emerging markets with inadequate regulation could present growth opportunities, albeit with compliance challenges.

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Conclusion

The market dynamics of oxycodone are characterized by a complex interplay of clinical utility, regulatory oversight, legal liabilities, and societal impact. Financially, the drug’s trajectory has shifted from exponential growth to a cautious decline, driven by regulatory actions and societal responses to the opioid epidemic. Stakeholders must navigate these shifting sands by balancing clinical needs with public health priorities, innovative formulations, and legal compliance.

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Key Takeaways

• Oxycodone’s historic dominance, especially in the U.S., has been eroded by regulatory restrictions and public health initiatives aimed at curbing misuse.
• Legal actions and settlement liabilities pose significant financial risks, influencing R&D investment and market strategies.
• The development of abuse-deterrent formulations and alternative pain management therapies will shape future revenue streams.
• Regional variability necessitates tailored market strategies, with growth potential in emerging markets constrained by regulatory and infrastructural barriers.
• Long-term market sustainability depends on innovation, policy adaptation, and corporate responsibility to balance effective pain management with addiction risk mitigation.

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FAQs

1. How have regulatory changes affected oxycodone sales in recent years?
Regulatory tightening, including prescription limits and abuse-deterrent mandates, has significantly reduced oxycodone prescribing volumes, leading to a decline in sales since 2016.

2. What role do abuse-deterrent formulations play in the current oxycodone market?
They aim to reduce misuse and diversion, capturing a growing segment of the market. While they have curtailed some abuse, their impact on overall sales is moderated by ongoing regulatory and prescriber shifts.

3. Are there upcoming patent expirations or generic entries affecting oxycodone’s financial outlook?
Yes. The expiration of patent protections for key formulations has increased generic competition, exerting downward pressure on prices and revenues.

4. What legal risks do pharmaceutical companies face related to oxycodone?
Manufacturers face extensive litigation, with multi-billion-dollar settlements and ongoing lawsuits that could impact financial stability and strategic focus.

5. Will oxycodone maintain its market relevance in the next decade?
While its role will diminish, oxycodone will likely remain relevant for specific pain indications, especially where alternatives are inadequate, though its overall market size will continue shrinking due to regulatory and societal pressures.

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Sources
[1] U.S. Food and Drug Administration (FDA). "Oxycodone Drug Label." 2022.
[2] IQVIA. "Opioid Prescribing Trends in the U.S." 2021.
[3] CDC. "Prescribing Data for Pain Medications." 2022.
[4] FDA. "Abuse-Deterrent Opioids." 2015.
[5] Purdue Pharma Bankruptcy Court Filings. 2021.