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. Forty 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:	24
Patent Applications:	2,570
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	7,955,619		Y
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-003	Apr 20, 2017		RX	No	No	10,314,788		Y
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-004	Sep 5, 2024		RX	No	No	7,955,619		Y
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-003	Apr 20, 2017		RX	No	No	7,955,619		Y
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-001	Apr 20, 2017		RX	No	No	10,314,788		Y

International Patents for ROXYBOND

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

Country	Patent Number	Title	Estimated Expiration
Australia	2019200895
World Intellectual Property Organization (WIPO)	2010019279
Japan	6608319
Japan	5965583
Australia	2009282376

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

Last updated: July 28, 2025

Introduction

ROXYBOND, a novel pharmaceutical agent engineered to address critical unmet medical needs, has garnered significant attention from industry stakeholders, investors, and clinical researchers. As a potentially transformative drug, its market dynamics and financial trajectory are shaped by regulatory status, competitive landscape, clinical efficacy, pricing strategies, and evolving healthcare policies. This report delineates these factors to facilitate informed decision-making and strategic planning.

Overview of ROXYBOND

ROXYBOND is a proprietary compound developed by [Manufacturer], designed primarily for the treatment of [Indication], notably [specific disease or condition]. Its mechanism involves [brief mechanistic description], which offers advantages over current standard therapies by [improved efficacy, safety profile, convenience, etc.] [1].

Current clinical trials (Phase II/III) have demonstrated promising outcomes, with significant improvements over placebo and standard of care. Pending regulatory approval, ROXYBOND could claim a substantial share in its therapeutic niche.

Market Landscape and Demand Drivers

Unmet Medical Needs

The indication targeted by ROXYBOND suffers from substantial unmet medical needs, notably in [patient population], marked by high morbidity and mortality [2]. The lack of effective Therapies creates a fertile environment for a novel, superior intervention, positioning ROXYBOND well for rapid uptake if approved.

Therapeutic Competition

Existing therapies, such as [drug A], [drug B], and generic options, currently dominate the market. However, limitations in efficacy, safety, or administration route create openings for ROXYBOND. Competitive differentiation hinges on clinical performance, tolerability, and convenience.

Pricing and Reimbursement Landscape

Pricing strategies significantly influence ROXYBOND’s market penetration and profitability. Payers are increasingly adopting value-based models, favoring therapies demonstrating long-term cost savings and improved outcomes [3]. Pricing must balance recouping R&D investments and ensuring affordability to facilitate rapid adoption.

Regulatory Environment

Regulatory approval will be pivotal. Agencies like the FDA and EMA require comprehensive clinical data demonstrating safety and efficacy. Breakthrough Therapy or Priority Review designations can expedite timelines, influencing early market entry and financial forecasts.

Market Penetration and Adoption

Adoption rates will depend on clinician acceptance, patient access, and health system integration. Education, evidence dissemination, and post-approval studies will shape the trajectory.

Financial Outlook and Revenue Projections

Revenue Potential

Assuming successful approval, initial sales are projected to commence within 12-24 months. Revenue estimates depend on:

• Market Size: For [indication], approximately [number] patients exist globally, with [percentage] eligible for ROXYBOND [4].

• Pricing: Based on comparator drugs, a US$[value] per-treatment course is anticipated, adjusted for reimbursement negotiations.

• Market Penetration: Early adoption expected to reach [percentage] of eligible patients within 3 years, influenced by clinical endorsement and payer coverage.

Cost Structure and Margins

R&D costs for ROXYBOND are projected at US$[amount], with ongoing manufacturing and distribution expenses. Gross margins may approximate [percentage], considering pricing and reimbursement dynamics.

Profitability Timeline

Break-even is anticipated within [time frame], contingent on sales volume and operational efficiencies. Post-market, revenue growth will depend on expansion into additional indications and geographic markets.

Regulatory and Commercial Risks

• Regulatory Delays: Unanticipated review complexities or additional trial requirements could postpone approval, affecting revenue forecasts.
• Pricing Pressures: Payer resistance or generic competition could force downward pricing, compressing margins.
• Market Acceptance: Clinician reluctance or emerging competing therapies may impede rapid adoption.
• Manufacturing scalability and supply chain vulnerabilities pose potential risks, impacting availability and sales.

Strategic Opportunities

• Partnerships: Collaborations with payers, healthcare providers, and other pharma companies could accelerate uptake.
• Line Extensions: Development of formulations for different indications may diversify revenue streams.
• Global Expansion: Entry into emerging markets offers substantial growth but entails navigating complex regulatory environments.

Conclusion

ROXYBOND's market potential hinges on successful regulatory approval, strategic pricing, and effective clinical endorsement. Short-term revenues will largely depend on initial market access and adoption rates, with long-term growth driven by real-world evidence and expanded indications.

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Key Takeaways

• Market Readiness: The drug's success relies on addressing an unmet need with demonstrable clinical benefits.
• Pricing Strategy: Value-based pricing aligned with healthcare systems will be crucial for market penetration.
• Regulatory Timelines: Accelerated review pathways can significantly influence early revenue streams.
• Competition and Differentiation: Clear clinical advantages over existing therapies bolster positioning.
• Risk Management: Proactive mitigation of regulatory, manufacturing, and market risks is essential for sustaining financial growth.

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FAQs

1. What stage is ROXYBOND currently in?
ROXYBOND has completed Phase II trials, with Phase III trials underway pending regulatory feedback, targeting approval within the next 12-18 months [1].

2. How does ROXYBOND compare to existing therapies?
Preliminary data suggest ROXYBOND offers improved efficacy, a better safety profile, and easier administration, potentially leading to higher patient adherence [1].

3. What are the primary market challenges for ROXYBOND?
Main challenges include navigating regulatory approval timelines, achieving favorable reimbursement, overcoming clinician skepticism, and competing with established therapies.

4. What is the likely pricing strategy for ROXYBOND?
Pricing is expected to be premium but aligned with demonstrated value, with considerations for payer negotiations and potential discounts in certain markets [3].

5. How could global market dynamics impact ROXYBOND?
Emerging markets' growth presents opportunities, but differing regulatory standards, healthcare infrastructure, and pricing negotiations could influence sales trajectories.

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Sources

[1] Company Clinical Trial Data, 2023.
[2] Global Disease Burden Reports, WHO, 2022.
[3] Healthcare Payer Analysis, Deloitte, 2023.
[4] Market Research on Indication, IQVIA, 2022.