OXYMORPHONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for oxymorphone hydrochloride and what is the scope of freedom to operate?

Oxymorphone hydrochloride is the generic ingredient in four branded drugs marketed by Endo Pharms, Endo Operations, Actavis Elizabeth, Hikma, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva, and is included in eighteen NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxymorphone hydrochloride has two hundred and four patent family members in thirty-two countries.

There are seven drug master file entries for oxymorphone hydrochloride. Nine suppliers are listed for this compound.

Summary for OXYMORPHONE HYDROCHLORIDE

International Patents:	204
US Patents:	5
Tradenames:	4
Applicants:	13
NDAs:	18
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	37
Patent Applications:	1,176
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OXYMORPHONE HYDROCHLORIDE
What excipients (inactive ingredients) are in OXYMORPHONE HYDROCHLORIDE?	OXYMORPHONE HYDROCHLORIDE excipients list
DailyMed Link:	OXYMORPHONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for OXYMORPHONE HYDROCHLORIDE

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

Sponsor	Phase
Assiut University	Phase 4
Kaohsiung Medical University Chung-Ho Memorial Hospital	Phase 4
National Institutes of Health (NIH)	Phase 2

See all OXYMORPHONE HYDROCHLORIDE clinical trials

Pharmacology for OXYMORPHONE HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for OXYMORPHONE HYDROCHLORIDE

Adjuvants, Anesthesia

Analgesics, Opioid

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for OXYMORPHONE HYDROCHLORIDE

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for OXYMORPHONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	20 mg, 30 mg and 40 mg	201655	1	2012-04-03
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	5 mg	201655	1	2012-03-26
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	7.5 mg, 10 mg, and 15 mg	201655	1	2012-03-23

US Patents and Regulatory Information for OXYMORPHONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-007	Feb 29, 2008		DISCN	Yes	No	8,871,779			Y
Avanthi Inc	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET;ORAL	203601-002	Jan 30, 2013	AB	RX	No	Yes
Sun Pharm Inds Ltd	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	203506-004	Apr 24, 2015		DISCN	No	No
Impax Labs	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079087-005	Jun 14, 2010		RX	No	No
Hikma	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200822-007	Jul 15, 2013		DISCN	No	No

Expired US Patents for OXYMORPHONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006	8,329,216
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-003	Jun 22, 2006	5,662,933
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-005	Feb 29, 2008	8,309,112
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-006	Dec 9, 2011	8,075,872
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-006	Feb 29, 2008	5,128,143

International Patents for OXYMORPHONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Slovenia	1842533
Hong Kong	1095081	Dosage form that is safeguarded from abuse
Norway	342922
Norway	20092503
Hungary	E032099

OXYMORPHONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxymorphone Hydrochloride

Introduction

Oxymorphone hydrochloride, a potent opioid analgesic, is used for managing moderate to severe pain. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Drivers

Several factors drive the demand for oxymorphone hydrochloride:

Increase in Surgical Procedures

The global rise in surgical procedures, including those for chronic conditions like cancer, osteoarthritis, and rheumatoid arthritis, has led to an increased need for effective pain management. Oxymorphone hydrochloride, with its analgesic properties, is often prescribed post-surgery to alleviate pain[3].

Chronic Pain Management

The drug is recommended for patients who do not respond to non-opioid pain medicines, making it a vital option for chronic pain management. This consistent demand from healthcare establishments such as hospitals, specialty clinics, and ambulatory surgical centers contributes to the market growth[3].

Preference in Pain Treatment

Healthcare personnel increasingly prefer oxymorphone hydrochloride due to its efficacy in treating pain caused by chronic ailments. This preference is particularly strong in regions like North America, where the prevalence of chronic diseases is high[3].

Market Size and Growth

Current Market Value

The market for opioid analgesics, including oxymorphone hydrochloride, is substantial. While specific figures for oxymorphone hydrochloride are not isolated, the broader oxycodone hydrochloride market, which shares similar dynamics, was valued at US$ 403.9 million in 2023 and is expected to grow at a CAGR of 4.8% from 2024 to 2034[3].

Forecasted Growth

The oxycodone hydrochloride market, which can serve as a proxy for understanding the growth trajectory of oxymorphone hydrochloride, is projected to reach US$ 675.2 million by 2034. This growth is driven by the increasing number of surgical procedures and the need for enhanced pain management activities[3].

Regional Analysis

North America

North America dominates the market for oxycodone hydrochloride and, by extension, oxymorphone hydrochloride. This dominance is attributed to the high prevalence of chronic diseases such as cancer, osteoarthritis, and rheumatoid arthritis in the U.S. The region is expected to continue its dominance during the forecast period[3].

Europe and Asia Pacific

Europe and the Asia Pacific region also show significant growth potential. In Europe, countries like Germany, the U.K., France, Italy, and Spain are key markets. In the Asia Pacific, the growing healthcare infrastructure and increasing awareness about pain management are driving the market[3].

Distribution Channels

Hospital Pharmacies

Hospital pharmacies account for the largest share of the oxycodone hydrochloride market, which is indicative of the distribution pattern for oxymorphone hydrochloride as well. Retail and online pharmacies also play significant roles, but hospital pharmacies remain the primary distribution channel[3].

Pricing and Cost Dynamics

Price Increases

Recent data shows significant price increases for oxymorphone hydrochloride products. For example, Amneal Pharmaceuticals reported a 40% increase in the price of various oxymorphone HCl ER tablets over the last three calendar years, attributed to increased marketing expenses and changes in industry dynamics[1].

Cost of Goods Sold (COGS)

The cost of goods sold for these products can also impact pricing. For instance, Harrow, Inc.'s Triesence Intraocular Suspension saw a 40% increase in price over three years due to increased COGS[1].

Regulatory and Legal Considerations

Patent and Licensing Agreements

The market for oxymorphone hydrochloride is influenced by patent and licensing agreements. For example, the settlement between Endo and Impax allowed Impax to sell generic oxymorphone ER without interruption, despite other generic manufacturers being enjoined by patent litigation[2].

Controlled Substance Status

Oxymorphone is classified as a Schedule II controlled substance under the Controlled Substances Act, which affects its distribution, prescription, and potential for diversion. This status also impacts the financial trajectory due to regulatory compliance costs and the risk of diversion[4].

Diversion and Abuse

Street Value and Diversion

The street value of oxymorphone products, typically retailing for one dollar per milligram, highlights the potential for diversion. Methods of diversion include fraudulent prescriptions, robberies, and polydrug trafficking organizations. This aspect can affect the legitimate market demand and pricing[4].

Financial Trajectory

Revenue Growth

The revenue growth for oxymorphone hydrochloride is expected to be steady, driven by the increasing demand for pain management solutions. The market's growth at a CAGR of around 4.8% indicates a stable financial trajectory[3].

Profit Margins

Profit margins for pharmaceutical companies manufacturing oxymorphone hydrochloride can be influenced by factors such as increased marketing expenses, changes in industry dynamics, and regulatory compliance costs. Despite these challenges, the consistent demand ensures relatively stable profit margins[1].

Key Takeaways

• Growing Demand: The market for oxymorphone hydrochloride is driven by the rise in surgical procedures and the need for chronic pain management.
• Regional Dominance: North America leads the market, with Europe and Asia Pacific showing significant growth potential.
• Pricing Dynamics: Significant price increases have been observed due to marketing expenses and changes in industry dynamics.
• Regulatory Impact: Patent agreements and controlled substance status affect the market and financial trajectory.
• Diversion Risks: The potential for diversion and abuse impacts the legitimate market and pricing.

FAQs

What are the primary drivers of the oxymorphone hydrochloride market?

The primary drivers include the rise in surgical procedures and the increasing need for chronic pain management.

How does the regional distribution of oxymorphone hydrochloride look?

North America dominates the market, followed by Europe and the Asia Pacific region.

What factors contribute to the price increases of oxymorphone hydrochloride products?

Increased marketing expenses and changes in industry dynamics are key factors contributing to price increases.

How does the controlled substance status of oxymorphone affect its market?

The controlled substance status impacts distribution, prescription, and potential for diversion, affecting the financial trajectory due to regulatory compliance costs.

What are the potential risks associated with the diversion of oxymorphone hydrochloride?

The risks include fraudulent prescriptions, robberies, and polydrug trafficking organizations, which can affect legitimate market demand and pricing.

Sources

1. 2024 Price Increase Report - Texas Department of State Health Services
2. Impax Laboratories Initial Decision - Federal Trade Commission
3. Oxycodone Hydrochloride Market Size & Share, Outlook, 2034 - Transparency Market Research
4. OXYMORPHONE - Diversion Control Division, U.S. Department of Justice