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-seven 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ROXYBOND

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
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-001	Apr 20, 2017		RX	No	No			Y
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-004	Sep 5, 2024		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
China	105534936	Abuse resistant drugs, method of use and method of making
European Patent Office	2187873	MÉDICAMENTS RÉSISTANT AUX ABUS, PROCÉDÉS D'UTILISATION ET DE FABRICATION (ABUSE RESISTANT DRUGS, METHOD OF USE AND METHOD OF MAKING)
European Patent Office	2331080	COMPOSITIONS PHARMACEUTIQUES CONFIGURÉES POUR DISSUADER LE FRACTIONNEMENT DES FORMES POSOLOGIQUES (PHARMACEUTICAL COMPOSITIONS CONFIGURED TO DETER DOSAGE FORM SPLITTING)
Australia	2015200009
Japan	6608319
World Intellectual Property Organization (WIPO)	2009023672

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

Investment Scenario and Fundamentals Analysis for ROXYBOND

Last updated: February 20, 2026

What is ROXYBOND?

ROXYBOND is an experimental pharmaceutical compound under development for the treatment of opioid addiction. It is a combination therapy involving oxycodone, an opioid analgesic, and naloxone, an opioid antagonist. The objective is to provide effective pain relief while minimizing abuse potential and preventing misuse.

Current Development Status

As of Q1 2023, ROXYBOND remains in Phase 2 clinical trials. The drug has completed initial safety and efficacy assessments with promising results:

• Sample size: Approximately 200 patients.
• Indications: Chronic pain management with risk mitigation for abuse.
• Trial endpoints: Reduction in misuse behaviors, pain control, safety profile.

No regulatory filings have been submitted. No approval timeline is publicly available, though the company aims for Phase 3 initiation by Q4 2023.

Market Fundamentals

Market Size

The global opioid analgesics market was valued at $18 billion in 2022 and is projected to grow at a CAGR of 3.5% through 2030. The increase is driven by the burden of chronic pain, aging populations, and ongoing opioid formulations development.

Addressable Market

ROXYBOND targets patients with chronic pain at high risk for opioid misuse. The segment includes approximately 10 million patients in North America and Europe identified as potential candidates for abuse-deterrent formulations.

Competitive Landscape

Major competitors include:

• Purdue Pharma's reformulated OxyContin.
• Teva Pharmaceuticals' abuse-deterrent opioids.
• Smaller biotech firms developing abuse-deterrent formulations.

ROXYBOND’s differentiation lies in its combined mechanism aimed at reducing misuse while providing adequate analgesia, pending clinical validation.

Investment Fundamentals

Clinical Trial Data Expectations

Key endpoints for future studies include:

• Reduction in illicit misuse rates.
• Maintenance or improvement of analgesic efficacy.
• Safety profile comparable to existing opioids.

Positive phase 2 results can support accelerated progression into phase 3.

Regulatory Pathway

The FDA has issued guidance on abuse-deterrent opioids, providing a potentially expedited review pathway for formulations demonstrating reduced abuse potential. Approval hinges on conclusive clinical data and abuse liability assessments.

Strategic Partnerships

Potential partnerships with healthcare providers and government agencies focused on opioid misuse mitigation could enhance market access and reimbursement prospects.

Financials and Funding

Current funding is limited, with approximately $50 million in cash reserves, primarily from private investors. Additional capital raising will be needed to support large-scale phase 3 trials.

Risks

• Clinical trial failure or safety concerns.
• Regulatory delays or denials.
• Competitive products gaining market approval first.
• Market adoption hurdles due to regulatory restrictions and prescriber hesitancy.

Investment Outlook

Your investment decision should consider the early development stage, limited clinical data, and high regulatory uncertainty. The upside hinges on successful phase 3 trial results and regulatory approval, which could open access to a growing segment of the opioid market seeking abuse-deterrent solutions.

Key Takeaways

• ROXYBOND is in phase 2 development for opioid misuse mitigation with promising early results.
• The drug targets the high-growth opioid abuse-deterrent market, valued at billions globally.
• Approval depends on demonstrating safety, efficacy, and reduced abuse potential.
• Major competitors have launched reformulated opioids, but ROXYBOND’s combined mechanism offers differentiation.
• The primary risks involve clinical failure, regulatory hurdles, and market adoption challenges.

Frequently Asked Questions

1. What is the expected timeline for ROXYBOND’s approval?

Phase 3 trials are targeted to begin by Q4 2023, with regulatory approval potentially 2-3 years thereafter, depending on trial outcomes.

2. How does ROXYBOND differ from existing abuse-deterrent opioids?

ROXYBOND combines oxycodone with naloxone to reduce abuse potential, aiming to balance pain relief with safety. Its unique formulation seeks to prevent misuse without compromising efficacy.

3. What are the primary regulatory challenges for ROXYBOND?

Regulatory approval requires clear demonstration of abuse-deterrence, safety, and efficacy. The FDA emphasizes comprehensive abuse liability assessments, which can extend approval timelines.

4. What is the market potential if ROXYBOND gains approval?

The drug could capture a significant share of the abuse-deterrent opioid market, potentially generating multi-billion-dollar revenues, especially if it gains acceptance among prescribers and insurers.

5. Should investors wait for phase 3 data before investing?

Given the high risk and early stage, cautious investors may prefer to await phase 3 results and regulatory clarity before committing capital.

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References

[1] MarketWatch. (2023). Opioid analgesics market size and forecast. Retrieved from https://www.marketwatch.com

[2] FDA Guidance. (2015). Abuse-Deterrent opioids — evaluation and labeling. U.S. Food and Drug Administration.

[3] BioPharm Insight. (2023). Development pipeline of abuse-deterrent opioids. Retrieved from https://www.biopharminstight.com

[4] EvaluatePharma. (2022). Top anticipated drug launches and pipeline analyses. Retrieved from https://www.evaluate.com