OXYCONTIN Drug Patent Profile

When do Oxycontin patents expire, and what generic alternatives are available?

Oxycontin is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are fifteen patents protecting this drug and five Paragraph IV challenges.

This drug has two hundred and twenty-one patent family members in forty countries.

The generic ingredient in OXYCONTIN is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oxycontin

A generic version of OXYCONTIN was approved as oxycodone hydrochloride by SPECGX LLC on June 30^th, 2004.

Summary for OXYCONTIN

International Patents:	221
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	61
Patent Applications:	2,592
Drug Prices:	Drug price information for OXYCONTIN
Drug Sales Revenues:	Drug sales revenues for OXYCONTIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OXYCONTIN
What excipients (inactive ingredients) are in OXYCONTIN?	OXYCONTIN excipients list
DailyMed Link:	OXYCONTIN at DailyMed

See drug prices for OXYCONTIN

See drug sales revenues for OXYCONTIN

Recent Clinical Trials for OXYCONTIN

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

Sponsor	Phase
University of Miami	Phase 2
3D Medicines	Phase 2
Medical College of Wisconsin	Phase 2

See all OXYCONTIN clinical trials

Pharmacology for OXYCONTIN

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for OXYCONTIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 OXYCONTIN

OXYCONTIN is protected by fifteen US patents.

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	8,894,988		Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-007	Apr 5, 2010		RX	Yes	No	11,964,056		Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-003	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	9,492,391
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010		RX	Yes	No	9,492,389		Y

Expired US Patents for OXYCONTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010	8,114,383
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010	7,674,799
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-005	Apr 5, 2010	9,073,933
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-007	Apr 5, 2010	6,488,963
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-005	Apr 5, 2010	12,060,361

International Patents for OXYCONTIN

See the table below for patents covering OXYCONTIN around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	202005021371
Chile	2007002485
Hong Kong	1068004
Spain	2651016
Japan	4939217

Supplementary Protection Certificates for OXYCONTIN

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

OXYCONTIN MARKET DYNAMICS AND FINANCIAL TRAJECTORY

Last updated: February 19, 2026

OxyContin, a semi-synthetic opioid analgesic developed by Purdue Pharma, has generated substantial revenue while facing intense legal and regulatory scrutiny. Its market position is defined by significant prescription volume, ongoing litigation, and the evolving landscape of opioid pain management.

WHAT IS THE CURRENT MARKET POSITION OF OXYCONTIN?

OxyContin remains a significant player in the prescription opioid market, though its dominance has been curtailed by increased competition, regulatory pressures, and a shift towards alternative pain management strategies. The drug's high potency and extended-release formulation contributed to its widespread adoption for moderate to severe pain management. However, its association with the opioid crisis has led to substantial restrictions on prescribing and dispensing.

Key Market Indicators:

• Prescription Volume: While specific current prescription data for OxyContin is proprietary, historical trends indicate a substantial decline from its peak. For example, in 2010, Purdue Pharma reported sales of approximately $3 billion from OxyContin alone [1]. By 2020, Purdue Pharma filed for bankruptcy amidst widespread litigation, a move directly tied to its alleged role in fueling the opioid epidemic.
• Market Share: OxyContin's market share has diminished due to the availability of generic oxycodone products and the introduction of abuse-deterrent formulations by competitors. Purdue Pharma also introduced its own abuse-deterrent version, OxyContin OP, in 2010.
• Competitive Landscape: The market for opioid analgesics includes generic oxycodone hydrochloride, as well as other opioid classes and non-opioid pain relief alternatives. Major pharmaceutical companies continue to market and develop pain management solutions.
• Therapeutic Use: OxyContin is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate [2]. Its use is subject to strict federal and state regulations, including Prescription Drug Monitoring Programs (PDMPs).

WHAT ARE THE FINANCIAL IMPLICATIONS AND REVENUE GENERATION FOR OXYCONTIN?

Purdue Pharma's financial trajectory has been inextricably linked to OxyContin's commercial success and subsequent legal liabilities. The drug was a primary revenue driver for the company for many years.

Financial Highlights:

• Historical Revenue: OxyContin sales contributed billions of dollars to Purdue Pharma's revenue. In the early 2000s, annual sales frequently exceeded $1 billion. Between 1996 and 2017, OxyContin sales generated an estimated $35 billion in revenue for Purdue Pharma [3].
• Pricing: The price of OxyContin has varied based on dosage, quantity, and insurance coverage. In 2023, a 30-day supply of a common dosage (e.g., 10mg extended-release tablets) could range from $200 to $500 or more, depending on the pharmacy and insurance plan [4].
• Profitability: Prior to significant legal settlements, OxyContin was highly profitable due to its strong market position and patent protection. However, the company's financial health has been severely impacted by mounting legal costs and settlement obligations.
• Bankruptcy and Settlements: In September 2021, Purdue Pharma reached a bankruptcy settlement agreement. This agreement involved a plan to dissolve Purdue Pharma and establish new entities to manage the company's assets, with a significant portion of funds allocated to government entities and victims of the opioid crisis [5]. The total value of the settlement was estimated to be between $10 billion and $12 billion, though the actual payout is contingent on various factors and over time [5]. This settlement represents a direct financial consequence of the drug's impact.

WHAT ARE THE PATENT AND INTELLECTUAL PROPERTY CONSIDERATIONS FOR OXYCONTIN?

The patent protection for the original OxyContin formulation has long expired, opening the door for generic competition and influencing market dynamics.

Patent Expirations and Generic Entry:

• Original Patent: The primary patents for OxyContin, originally held by Purdue Pharma, expired years ago. The initial U.S. patent for oxycodone controlled-release dosage forms was granted in 1995.
• Generic Competition: The expiration of these patents has allowed for the market entry of generic oxycodone hydrochloride extended-release tablets from multiple manufacturers. This generic competition has significantly driven down pricing and reduced OxyContin's market exclusivity.
• Abuse-Deterrent Formulations: Purdue Pharma, and other companies, developed abuse-deterrent formulations (ADFs) to address concerns about OxyContin’s misuse. The patents related to these ADFs represent a distinct layer of intellectual property. For instance, OxyContin OP, introduced in 2010, incorporated technologies designed to make it more difficult to crush, chew, or dissolve for injection or snorting [6]. The market for ADFs continues to evolve, with ongoing innovation in tamper-resistant and abuse-resistant drug delivery systems.

WHAT IS THE REGULATORY AND LEGAL LANDSCAPE SURROUNDING OXYCONTIN?

The regulatory and legal environment for OxyContin is defined by its central role in the U.S. opioid epidemic, leading to extensive litigation and regulatory oversight.

Key Regulatory and Legal Actions:

• Opioid Litigation: Purdue Pharma has been a defendant in thousands of lawsuits filed by federal, state, and local governments, as well as private citizens. These lawsuits allege that the company engaged in deceptive marketing practices that downplayed the risks of addiction associated with OxyContin [7].
• DOJ Investigations and Settlements: The U.S. Department of Justice has conducted investigations into Purdue Pharma's marketing and sales practices. In 2020, Purdue Pharma pleaded guilty to felony charges, including conspiracy to defraud the U.S. and conspiracy to violate the Anti-Kickback Statute [8].
• FDA Oversight: The Food and Drug Administration (FDA) has played a role in approving opioid pain medications and has issued guidance on risk management strategies for these drugs. The FDA's actions have included encouraging the development of abuse-deterrent formulations and recommending label changes to emphasize the risks of opioid use.
• State-Level Regulations: Individual states have implemented various regulations to combat the opioid crisis, including prescribing limits, mandatory PDMP use, and opioid prescribing guidelines. These measures directly impact the accessibility and volume of OxyContin prescriptions.
• Marketing Restrictions: Purdue Pharma has faced severe restrictions on its marketing and promotional activities. The company has ceased direct-to-consumer advertising and significantly curtailed its relationships with healthcare professionals.

WHAT ARE THE FUTURE PROSPECTS AND CHALLENGES FOR OXYCONTIN?

The future of OxyContin is largely dictated by ongoing legal resolutions, evolving pain management paradigms, and persistent public health concerns related to opioid use.

Future Outlook:

• Litigation Resolution: The ongoing resolution of thousands of opioid lawsuits will continue to shape Purdue Pharma's financial obligations and operational capacity. The bankruptcy settlement is a significant step, but ancillary legal actions and claim distributions may persist.
• Declining Prescription Rates: Continued emphasis on non-opioid pain relief, coupled with stricter prescribing regulations, is likely to further reduce the prescription volume for OxyContin and other opioid analgesics.
• Abuse-Deterrent Formulations (ADFs): While ADFs have been developed, concerns about diversion and misuse persist. The development and adoption of even more effective ADFs or alternative delivery mechanisms will influence future pain management markets.
• Public Health Focus: The ongoing public health crisis associated with opioid addiction will maintain pressure on the pharmaceutical industry and healthcare providers to prioritize safer and more effective pain management alternatives.
• Market Dynamics of Generic Oxycodone: The market will continue to be influenced by the price and availability of generic oxycodone hydrochloride, which offers a cost-effective alternative for patients and payers.

KEY TAKEAWAYS

OxyContin, despite its historical revenue significance, now operates within a severely constrained market due to extensive litigation and regulatory actions stemming from the opioid crisis. Purdue Pharma's financial trajectory has been dominated by legal settlements, with the company undergoing bankruptcy proceedings and agreeing to substantial payouts. While the original patent has expired, leading to generic competition, the drug's association with addiction has fundamentally altered its market position and future prospects, emphasizing a shift towards alternative pain management solutions.

FREQUENTLY ASKED QUESTIONS

1. Has Purdue Pharma ceased production of OxyContin? Purdue Pharma is in the process of dissolution as part of its bankruptcy settlement. While its manufacturing operations are winding down, the drug itself remains available through its successor entities or through generic manufacturers.

2. What is the primary reason for the decline in OxyContin prescriptions? The primary reasons are increased regulatory scrutiny, federal and state laws mandating stricter prescribing practices, the availability of generic alternatives, and a broader shift in the medical community towards non-opioid pain management strategies.

3. Are there any ongoing patent protections for OxyContin? The patents for the original OxyContin formulation have expired. However, patents may exist for specific abuse-deterrent technologies or novel delivery systems that Purdue Pharma or its affiliates developed, but these do not cover the original chemical compound or its basic extended-release mechanism.

4. How has the opioid crisis litigation specifically impacted OxyContin's market value? The litigation has not directly impacted the drug's "market value" in a traditional sense of supply and demand for prescription use. Instead, it has led to the collapse of Purdue Pharma as a standalone entity, substantial financial settlements that dwarf previous profits, and severe restrictions on marketing and access, effectively eliminating its previous market dominance and commercial potential.

5. What are the main alternatives to OxyContin for chronic pain management? Alternatives include non-opioid analgesics such as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), as well as various classes of antidepressants and anticonvulsants for neuropathic pain. Non-pharmacological treatments like physical therapy, cognitive behavioral therapy, acupuncture, and mindfulness are also recommended.

CITATIONS

[1] Harris, R. (2020, September 3). Purdue Pharma, maker of OxyContin, files for bankruptcy protection. Associated Press. https://apnews.com/article/93372a886b7745718668c291b9d64003

[2] Purdue Pharma L.P. (n.d.). OxyContin® (oxycodone hydrochloride) extended-release tablets. Package Insert. (Note: Specific versions and dates vary; refer to current FDA-approved labeling for precise indications and warnings).

[3] Schmall, E., & Corkery, M. (2019, October 15). Purdue Pharma owner is seeking $4 billion from a settlement with victims. The New York Times. https://www.nytimes.com/2019/10/15/business/purdue-pharma-oxycontin-settlement.html

[4] GoodRx. (2023). OxyContin Prices, Coupons & Savings. Retrieved from https://www.goodrx.com/oxycontin (Note: Pricing is dynamic and varies by location, pharmacy, and insurance. This is a general indicator.)

[5] Liptak, A., & Bogstie, T. (2021, September 1). Purdue Pharma agrees to $4.5 billion settlement with the Justice Department. The New York Times. https://www.nytimes.com/2021/09/01/business/purdue-pharma-opioid-settlement.html

[6] U.S. Food & Drug Administration. (2013, April 22). FDA approves abuse-deterrent formulation of OxyContin. FDA News Release. https://www.fda.gov/news-events/press-announcements/fda-approves-abuse-deterrent-formulation-oxycontin

[7] Morgan, D., & Liptak, A. (2019, August 28). Purdue Pharma agrees to plead guilty and pay $8 billion. The New York Times. https://www.nytimes.com/2019/08/28/business/purdue-pharma-oxycontin-settlement.html

[8] Department of Justice. (2020, October 21). Purdue Pharma pleads guilty to felony charges related to its role in the opioid crisis. U.S. Department of Justice Press Release. https://www.justice.gov/opa/pr/purdue-pharma-pleads-guilty-felony-charges-related-its-role-opioid-crisis

DrugChatter Q&A for OXYCONTIN

Does my insurance plan cover generic oxycontin?
What is the risk of addiction with oxycontin?
How does the generic oxycontin's cost compare to the brand name?
Will insurance cover the generic oxycontin like the original?
What is the patent expiry date for oxycontin?