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 eighteen patents protecting this drug and five Paragraph IV challenges.

This drug has three hundred and seventy-two patent family members in forty-eight countries.

The generic ingredient in OXYCONTIN is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Thirty-eight 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:	372
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	61
Patent Applications:	3,901
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 eighteen 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	022272-004	Apr 5, 2010		RX	Yes	No			Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010		RX	Yes	No			Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-003	Apr 5, 2010		RX	Yes	No

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	022272-002	Apr 5, 2010
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-003	Apr 5, 2010
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-005	Apr 5, 2010

International Patents for OXYCONTIN

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

Country	Patent Number	Title	Estimated Expiration
Norway	20074412
Cyprus	1111487
Denmark	1258246

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

The Market Dynamics and Financial Trajectory of OxyContin

Introduction

OxyContin, a controlled-release formulation of the opioid oxycodone, has been at the center of the opioid epidemic in the United States and globally. Since its introduction in 1995, the drug has had a profound impact on the pharmaceutical market, public health, and the financial fortunes of its manufacturers. Here, we delve into the market dynamics and financial trajectory of OxyContin.

Market Introduction and Initial Success

OxyContin was approved by the FDA in 1995 and launched by Purdue Pharma in 1996. Initially, it was marketed primarily for cancer pain, but Purdue quickly expanded its target market to include non-cancer pain, a much larger and more lucrative segment[1][3][4].

Aggressive Marketing Strategies

Purdue Pharma employed aggressive marketing tactics to promote OxyContin. This included expanding its sales force, targeting primary care physicians who may not have been adequately trained in pain management, and using multiple promotional approaches. These efforts led to rapid growth in sales and prescriptions, with OxyContin becoming the most frequently prescribed brand-name narcotic medication for treating moderate-to-severe pain by 2001[4].

Financial Performance

The financial success of OxyContin was swift and substantial. By 2001, sales had exceeded $1 billion annually, making it one of the most profitable drugs on the market. Between 1995 and 2001, OxyContin alone generated $2.8 billion in sales[3][4].

Global Expansion

OxyContin's success was not limited to the United States. The drug was sold in numerous countries, including Canada, China, Japan, and the UK. In these markets, OxyContin and other opioids containing oxycodone continued to generate significant revenue even after Purdue Pharma's U.S. business unit declared bankruptcy in 2019. For instance, in Europe's five largest economies, Mundipharma, the Sackler family's international pharmaceutical business, recorded combined sales of $439 million from 2020 to 2022[2].

Impact of Marketing on Prescription Trends

The initial marketing of OxyContin significantly influenced prescription trends. Areas with higher cancer incidence received more doses of opioids per capita, highlighting the targeted marketing efforts by Purdue Pharma. This led to a substantial increase in opioid prescriptions, particularly for oxycodone, which accounted for the majority of the growth in prescription opioids from 1999 to 2018[1].

Abuse and Diversion

Despite its initial success, OxyContin's controlled-release formulation did not prevent abuse and diversion. The drug's high content of oxycodone and the ability to dissolve it in water for injection led to widespread abuse. By early 2000, reports of OxyContin abuse and diversion began to surface, prompting regulatory actions and risk management plans to mitigate these issues[4].

Regulatory Actions and Consequences

In response to the abuse and diversion, the FDA and DEA implemented various measures, including stronger safety warnings, risk management plans, and disciplinary actions against improper prescribing and sales practices. These efforts aimed to reduce the misuse of OxyContin but did not entirely halt the drug's contribution to the opioid epidemic[4].

Financial Consequences and Litigation

The opioid epidemic and subsequent litigation have had significant financial implications for Purdue Pharma and the Sackler family. Despite generating hundreds of millions of dollars in profits globally, the company faced massive legal and financial repercussions. Purdue Pharma declared bankruptcy in 2019, and the Sackler family's assets have been subject to intense scrutiny and legal action. The financial analysis of Mundipharma revealed that while the company continued to make substantial profits, a significant portion of these earnings were earmarked for settling litigation and helping opioid victims[2].

Intergenerational and Societal Impact

The marketing and distribution of OxyContin have had profound intergenerational and societal impacts. The opioid epidemic has affected adult wellbeing and led to significant intergenerational consequences, including increased mortality rates and long-term health issues. The epidemic has also highlighted systemic issues in healthcare access and the need for more stringent regulations on opioid prescriptions[1].

Current Market and Financial Status

As of recent years, the Sackler family's global pharmaceutical empire, Mundipharma, continues to operate and generate significant revenue. However, the company has diversified its product portfolio, and the sales of strong opioids, including OxyContin, have reduced as a percentage of total sales. Despite this, Mundipharma companies have paid out substantial dividends to holding companies owned by the Sacklers, and the business in China is being considered for sale, potentially fetching over $1 billion[2].

Key Takeaways

• Aggressive Marketing: OxyContin's success was largely driven by aggressive marketing strategies targeting a broad range of pain conditions.
• Financial Success: The drug generated billions of dollars in sales, both in the U.S. and globally.
• Abuse and Diversion: Despite its controlled-release formulation, OxyContin was widely abused and diverted, contributing to the opioid epidemic.
• Regulatory Actions: Various regulatory measures were implemented to mitigate abuse, but the impact of OxyContin on public health remained significant.
• Financial Consequences: The opioid epidemic led to massive legal and financial repercussions for Purdue Pharma and the Sackler family.
• Societal Impact: The drug has had profound intergenerational and societal impacts, highlighting the need for better healthcare policies and regulations.

FAQs

What was the initial market positioning of OxyContin?

OxyContin was initially marketed primarily for cancer pain but was quickly expanded to target non-cancer pain, a much larger market segment[1][3][4].

How did Purdue Pharma market OxyContin?

Purdue Pharma used aggressive marketing tactics, including an expanded sales force and multiple promotional approaches, to encourage physicians to prescribe OxyContin for non-cancer pain[4].

What were the financial consequences of the opioid epidemic for Purdue Pharma?

Purdue Pharma declared bankruptcy in 2019 due to the financial repercussions of the opioid epidemic and subsequent litigation. However, the Sackler family's global pharmaceutical business, Mundipharma, continues to generate significant profits[2].

How has the global market for OxyContin evolved?

The global market for OxyContin and other opioids has continued to generate revenue, although sales of strong opioids have reduced as a percentage of total sales. Mundipharma has diversified its product portfolio and continues to operate in over 120 countries[2].

What regulatory actions were taken to address OxyContin abuse and diversion?

Regulatory actions included stronger safety warnings, risk management plans, and disciplinary actions against improper prescribing and sales practices. The FDA and DEA also collaborated on these efforts[4].

How has the opioid epidemic affected public health and intergenerational outcomes?

The opioid epidemic has led to significant increases in mortality rates, long-term health issues, and intergenerational consequences, highlighting the need for better healthcare policies and regulations[1].

Sources

1. The Origins and Deep Ripples of the Opioid Epidemic - Cowles Foundation for Research in Economics, Yale University.
2. Revealed: How the Sackler family's opioid empire continues to make hundreds of millions of dollars in profits around the world - Finance Uncovered.
3. The opioid epidemic in North America: Implications for Australia - Australian Institute of Criminology.
4. OxyContin Abuse and Diversion and Efforts to Address the Problem - U.S. Government Accountability Office.