Oxycodone hydrochloride - Generic Drug Details

What are the generic 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 seventeen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for oxycodone hydrochloride

International Patents:	244
US Patents:	17
Tradenames:	5
Applicants:	31
NDAs:	52
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	632
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
Baylor College of Medicine	PHASE1
Christopher D. Verrico	PHASE1
Region Skane	PHASE4

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	022272-001	Apr 5, 2010		RX	Yes	No	8,894,987		Y
Amneal Pharms	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	203638-001	Jun 3, 2014	AB	RX	No	No
Hibrow Hlthcare	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	207511-001	Nov 23, 2016	AA	RX	No	No
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-005	Apr 5, 2010		RX	Yes	Yes	8,808,741
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-002	Apr 5, 2010		RX	Yes	No	8,894,987		Y
Novel Labs Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	204021-001	Jun 12, 2017		DISCN	No	No

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	022272-004	Apr 5, 2010	10,130,591
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-007	Apr 5, 2010	8,337,888
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-002	Apr 5, 2010	9,060,976
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-003	Apr 5, 2010	9,060,976
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010	9,060,976
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-004	Apr 5, 2010	6,488,963

International Patents for oxycodone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Denmark	2080514
Serbia	52402	FARMACEUTSKI DOZNI OBLICI REZISTENTNI NA ZLOUPOTREBU KOJI SADRŽE OPIOIDNI ANALGETIK (TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC)
Japan	2015044834	オピオイド鎮痛薬を含む不正改変抵抗性経口医薬剤形 (ORAL PHARMACEUTICAL DOSAGE FORM HAVING RESISTIVITY TO UNAUTHORIZED ALTERATION CONTAINING OPIOID ANALGESIC)
Australia	2007287341	Tamper resistant oral pharmaceutical dosage forms comprising an opioid analgesic
Cyprus	1114061
Germany	602007002596

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: February 19, 2026

What is the Market Size and Revenue of Oxycodone Hydrochloride?

Oxycodone hydrochloride is a semi-synthetic opioid used primarily to manage severe pain. It is marketed under brand names such as OxyContin and Percocet, alongside generic versions.

• Global opioid analgesics market, including oxycodone, was valued at approximately USD 7.1 billion in 2021 (Market Research Future, 2022).
• Oxycodone accounted for roughly 50% of this revenue, translating to an estimated USD 3.55 billion in 2021.
• The market is projected to grow at a CAGR of 4% to 5% through 2027, driven by increased pain management needs and regulatory approvals of new formulations (Grand View Research, 2022).

How Do Market Factors Influence Revenue and Pricing?

Regulatory Environment

• Strict controls on opioid distribution affect supply chains and market access.
• Rescheduling and tightening of prescribing guidelines have limited growth in some regions, especially North America.
• In the U.S., the Drug Enforcement Administration (DEA) reclassified certain formulations, impacting manufacturing and sales channels.

Patent Landscape and Generic Competition

• Original formulations, such as OxyContin, held patents that expired or are nearing expiry, facilitating generic entry.
• Generic versions generally sell at 40% to 60% lower prices; this reduces revenue stream for patent holders but expands market volume.

Healthcare Trends

• Growing focus on multimodal pain management may decrease reliance solely on oxycodone.
• Push for alternative therapies and non-opioid pain medications limits market expansion.

Geographical Variations

• North America dominates, with over 75% of global revenue, due to high opioid consumption and prescribing rates.
• Markets in Europe, Asia-Pacific, and Latin America are increasing but face varying regulatory and cultural barriers.

What Are the Key Revenue Drivers and Challenges?

Drivers	Challenges
High prevalence of chronic pain conditions	Stringent regulatory controls
Established brand recognition	Rising opioid misuse and abuse concerns
Increasing prevalence of pain-inducing conditions	Litigation risks and class-action lawsuits
Development of abuse-deterrent formulations	Shift toward non-opioid alternatives

How Are Clinical and Regulatory Developments Impacting Financial Outcomes?

• The approval of abuse-deterrent formulations (ADFs) has sustained sales volume by addressing abuse concerns; for example, Purdue Pharma’s reformulated OxyContin in 2010 contributed to prolonged sales.
• Regulatory restrictions on prescribing, such as the CDC guidelines of 2016 limiting initial opioid doses, have tempered growth.
• Legal liabilities and settlements, notably Purdue Pharma’s 2021 bankruptcy and large opioid-related litigations, have resulted in financial settlements exceeding USD 6 billion, affecting revenue projections and company valuations.

What Is the Future Financial Trajectory?

• The market is expected to grow at a moderate pace due to regulatory constraints.
• Market entrants investing in abuse-deterrent technologies can sustain premium pricing and market share.
• Declines in North American markets could be offset by growth in emerging regions, driven by increased healthcare access and pain management protocols.

What Are the Major Competitive Players?

• Purdue Pharma (OxyContin)
• Teva Pharmaceutical Industries
• Johnson & Johnson (via Janssen)
• Mallinckrodt Pharmaceuticals
• Endo International

These firms hold significant market share through patent rights, brand recognition, or generic manufacturing.

Key Takeaways

• Oxycodone hydrochloride remains a significant contributor to the global opioid analgesics market, with USD 3.55 billion in estimated revenue in 2021.
• Market growth faces constraints from regulatory measures, legal challenges, and increasing competition from non-opioid therapies.
• Technological innovations, such as abuse-deterrent formulations, help sustain profitability.
• North America remains the dominant market due to high consumption; growth prospects are more limited in mature regions.
• Legal liabilities contribute to financial uncertainty, with billions in settlements impacting profitability for key players.

FAQs

1. How is the patent landscape affecting oxycodone market revenues?
Patent expirations have opened markets for generics, reducing prices and revenue for original patent holders. Companies invest in new formulations to maintain exclusivity.

2. What regulatory changes have most impacted oxycodone sales in recent years?
The CDC guidelines of 2016, DEA scheduling updates, and state-level prescription monitoring programs have limited prescribing patterns, impacting revenues.

3. Are there new formulations that could alter the oxycodone market?
Yes, abuse-deterrent formulations, approved by the FDA, aim to reduce misuse and are priced at a premium, potentially maintaining or elevating revenues.

4. How does the legal climate influence market projections?
Litigation liabilities and settlements significantly threaten future revenue streams. Major settlements, like Purdue Pharma’s USD 6 billion, create financial uncertainties.

5. What regions show the most growth potential for oxycodone?
Emerging markets in Asia-Pacific and Latin America are expanding, driven by increased healthcare access and pain management adoption.

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References

[1] Market Research Future. (2022). Global opioid analgesics market forecast.
[2] Grand View Research. (2022). Opioid analgesics market size, share & trends.