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Last Updated: December 22, 2024

OXYMORPHONE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Oxymorphone Hydrochloride, and what generic alternatives are available?

Oxymorphone Hydrochloride is a drug marketed by 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 thirteen NDAs.

The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Oxymorphone Hydrochloride

A generic version of OXYMORPHONE HYDROCHLORIDE was approved as oxymorphone hydrochloride by IMPAX LABS on June 14th, 2010.

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  • What is the 5 year forecast for OXYMORPHONE HYDROCHLORIDE?
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Drug patent expirations by year for OXYMORPHONE HYDROCHLORIDE
Recent Clinical Trials for OXYMORPHONE HYDROCHLORIDE

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

SponsorPhase
Assiut UniversityPhase 4
Kaohsiung Medical University Chung-Ho Memorial HospitalPhase 4
Shirley Ryan AbilityLabPhase 2

See all OXYMORPHONE HYDROCHLORIDE clinical trials

Pharmacology for OXYMORPHONE HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for OXYMORPHONE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for OXYMORPHONE HYDROCHLORIDE
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
Sun Pharm Inds Ltd OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 203506-006 Apr 24, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Specgx Llc OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 202946-004 Jun 27, 2014 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 201187-001 Dec 15, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurolife Pharma Llc OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 204459-001 Apr 26, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 201187-002 Dec 15, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 091443-002 Feb 15, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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