ROXYBOND Drug Patent Profile

When do Roxybond patents expire, and when can generic versions of Roxybond launch?

Roxybond is a drug marketed by Protega Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-three patent family members in ten countries.

The generic ingredient in ROXYBOND 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 Roxybond

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

Summary for ROXYBOND

International Patents:	23
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	28
Patent Applications:	2,413
Drug Prices:	Drug price information for ROXYBOND
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ROXYBOND
What excipients (inactive ingredients) are in ROXYBOND?	ROXYBOND excipients list
DailyMed Link:	ROXYBOND at DailyMed

See drug prices for ROXYBOND

Pharmacology for ROXYBOND

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for ROXYBOND

ROXYBOND is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-001	Apr 20, 2017		RX	No	No			Y
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-003	Apr 20, 2017		RX	No	No			Y
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-004	Sep 5, 2024		RX	No	No			Y
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-003	Apr 20, 2017		RX	No	No			Y

International Patents for ROXYBOND

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

Country	Patent Number	Title	Estimated Expiration
Mexico	336789	FARMACOS RESISTENTES AL ABUSO, METODO DE USO Y METODO DE FABRICACION. (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING.)
Japan	5965583
Australia	2009282376	Pharmaceutical compositions configured to deter dosage form splitting
Canada	2923102	MEDICAMENTS RESISTANT AUX ABUS, PROCEDES D'UTILISATION ET DE FABRICATION (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING)

Supplementary Protection Certificates for ROXYBOND

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 RoxyBond

Introduction to RoxyBond

RoxyBond, an immediate-release (IR) oxycodone tablet, has been approved by the US FDA for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Developed by Protega Pharmaceuticals LLC, RoxyBond features a unique abuse-deterrent formulation designed to reduce misuse and abuse[1].

Market Need and Demand

The global oxycodone drugs market is driven by the growing burden of chronic diseases such as cancer, rheumatoid arthritis, lower back pain, and fibromyalgia. Lifestyle factors like smoking, drinking, obesity, and low physical activity levels contribute to the increasing incidence of chronic pain diseases, thereby boosting the demand for oxycodone drugs[3][4].

Chronic Pain Prevalence

Chronic pain affects a significant portion of the population, with conditions like neuropathic disease and musculoskeletal disorders contributing to the rising demand for effective pain management solutions. This trend is expected to continue, driving the growth of the oxycodone market[4].

Regional Market Dominance

North America, particularly the United States, holds a substantial market share in the global oxycodone drugs market. This region is expected to dominate the market throughout the forecast period, with the U.S. market projected to exhibit a CAGR of 5.9% between 2024 and 2032[4].

Market Size and Growth Projections

The global oxycodone drugs market was valued at approximately USD 5.4 billion in 2023 and is anticipated to grow at a CAGR of 5.7% between 2024 and 2032, reaching an estimated value of USD 8.9 billion by 2032[4].

Segment Analysis

The market is segmented by drug type, dosage form, indication, distribution channel, and region. Hospital pharmacies are expected to exhibit a significant CAGR, indicating a strong demand for oxycodone drugs in clinical settings[4].

Financial Trajectory

Revenue Projections

Given the market growth projections, RoxyBond is poised to contribute significantly to the revenue of Protega Pharmaceuticals LLC. With the market expected to grow from USD 5.46 billion in 2024 to USD 8.29 billion by 2032, RoxyBond's unique abuse-deterrent features are likely to capture a substantial share of this growing market[3].

Competitive Advantage

RoxyBond's proprietary SentryBond technology provides multiple levels of protection against physical manipulation, chemical extraction, and other forms of misuse. This technology is a key differentiator in the market, potentially increasing the product's adoption rate among healthcare providers and patients[1][5].

Distribution and Sales Channels

Hospital Pharmacies

Hospital pharmacies are expected to be a major distribution channel for RoxyBond, given the high demand for opioid analgesics in clinical settings. This segment is projected to exhibit a CAGR of 5.9% between 2024 and 2032[4].

Retail and Online Pharmacies

In addition to hospital pharmacies, drug stores, retail pharmacies, and online pharmacies will also play crucial roles in the distribution of RoxyBond. The convenience and accessibility offered by these channels will help in reaching a broader patient base[4].

Regulatory Environment

FDA Approval

RoxyBond has received FDA approval for its immediate-release formulation, which includes a new 10 mg dose. This approval underscores the regulatory support for abuse-deterrent formulations, which are critical in addressing the national epidemic of prescription opioid overdose[5].

Compliance and Safety

The FDA's approval process ensures that RoxyBond meets stringent safety and efficacy standards. The product's design to resist physical manipulation and chemical extraction aligns with regulatory efforts to combat opioid misuse[1][5].

Technological Innovations

SentryBond Technology

Protega's proprietary SentryBond technology is a significant innovation in the field of opioid formulations. This technology makes the tablet more difficult to manipulate for misuse and abuse, even when subjected to physical or chemical alterations. The potential for this technology to be applied in other medications further enhances its value[1][5].

Market Challenges and Opportunities

Abuse and Misuse

Despite the abuse-deterrent features, there is still a risk of abuse via intranasal, oral, and IV routes. Continuous monitoring and improvement of the formulation will be necessary to address these challenges[5].

Competitive Landscape

The oxycodone market is competitive, with key players such as Collegium Pharmaceutical and Mundipharma International. RoxyBond's unique features and regulatory approvals position it favorably in this competitive landscape[3].

Industry Expert Insights

"Data show that many people abuse immediate-release prescription opioids. With the launch of RoxyBond, we are now able to offer healthcare providers a treatment option that is expected to reduce abuse and misuse while providing their patients relief from pain," said Dr. Stefan Aigner, Chairman and CEO of Protega Pharmaceuticals LLC[1].

Key Statistics

• Market Size (2023): USD 5.4 billion[4]
• Forecasted Market Size (2032): USD 8.9 billion[4]
• CAGR (2024-2032): 5.7%[4]
• North America Market Share (2023): 42.7%[4]
• U.S. Market CAGR (2024-2032): 5.9%[4]

Conclusion

RoxyBond is well-positioned to capitalize on the growing demand for oxycodone drugs, driven by the increasing prevalence of chronic pain diseases. Its unique abuse-deterrent formulation and FDA approvals make it a valuable addition to the market, offering both clinical efficacy and safety.

Key Takeaways

• Growing Market Demand: The global oxycodone drugs market is expected to grow significantly due to the rising incidence of chronic pain diseases.
• Abuse-Deterrent Technology: RoxyBond's SentryBond technology provides multiple levels of protection against misuse and abuse.
• Regulatory Support: FDA approval for RoxyBond underscores the regulatory focus on safety and efficacy in opioid formulations.
• Competitive Advantage: RoxyBond's unique features position it favorably in a competitive market.
• Distribution Channels: Hospital pharmacies, retail pharmacies, and online pharmacies will be key distribution channels.

FAQs

What is RoxyBond and how is it different from other oxycodone formulations?

RoxyBond is an immediate-release oxycodone tablet with a unique abuse-deterrent formulation using SentryBond technology, which makes it more difficult to manipulate for misuse and abuse.

What are the key factors driving the growth of the oxycodone drugs market?

The growth is driven by the increasing burden of chronic diseases such as cancer, rheumatoid arthritis, and lower back pain, as well as lifestyle factors contributing to chronic pain.

Which regions are expected to dominate the oxycodone drugs market?

North America, particularly the United States, is expected to dominate the market throughout the forecast period.

How does RoxyBond's SentryBond technology work?

SentryBond technology uses physical and chemical barriers to make the tablet resistant to cutting, crushing, grinding, and chemical extraction, reducing the potential for misuse and abuse.

What are the potential challenges for RoxyBond in the market?

Despite its abuse-deterrent features, there is still a risk of abuse via intranasal, oral, and IV routes, and the product must compete in a highly competitive market.

Sources

1. Protega Pharmaceuticals LLC Announces Commercialization of Oxycodone Hydrochloride Tablets CII in the US - Drug Development.
2. Daiichi Sankyo Group Value Report 2020 - Daiichi Sankyo.
3. Oxycodone Drugs Market Size, Growth Analysis Report, 2024-2032 - Polaris Market Research.
4. Oxycodone Drugs Market Share | 2024 - 2032 Growth Report - Grand View Research.
5. FDA approves new dose for abuse-deterrent oxycodone - Healio.

Last updated: 2024-12-19