OXAYDO Drug Patent Profile

Which patents cover Oxaydo, and what generic alternatives are available?

Oxaydo is a drug marketed by Zyla and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in six countries.

The generic ingredient in OXAYDO 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 Oxaydo

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

Summary for OXAYDO

International Patents:	13
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	1
Patent Applications:	2,570
Drug Prices:	Drug price information for OXAYDO
What excipients (inactive ingredients) are in OXAYDO?	OXAYDO excipients list
DailyMed Link:	OXAYDO at DailyMed

See drug prices for OXAYDO

Recent Clinical Trials for OXAYDO

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

Sponsor	Phase
Stanford University	Phase 3

See all OXAYDO clinical trials

Pharmacology for OXAYDO

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for OXAYDO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OXAYDO	Tablets	oxycodone hydrochloride	5 mg and 7.5 mg	202080	1	2012-02-07

US Patents and Regulatory Information for OXAYDO

OXAYDO is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011		DISCN	Yes	No	7,201,920		Y
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011		DISCN	Yes	No	7,201,920		Y

Expired US Patents for OXAYDO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	7,201,920
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	9,492,443
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	7,201,920
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	7,510,726
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	7,981,439
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	9,492,443

International Patents for OXAYDO

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

Country	Patent Number	Title	Estimated Expiration
Canada	2547334	PROCEDES ET COMPOSITIONS POUR EMPECHER UN ABUS DE FORMES PHARMACEUTIQUES CONTENANT DES OPIOIDES (METHODS AND COMPOSITIONS FOR DETERRING ABUSE OF OPIOID CONTAINING DOSAGE FORMS)
Australia	2010200979	Methods and compositions for deterring abuse of opioid containing dosage forms
European Patent Office	2420225	Procédés et compositions permettant d'empêcher l'abus d'opioïde contenant des formes de dosage (Methods and compositions for deterring abuse of opioid containing dosage forms)
Australia	2004294953	Methods and compositions for deterring abuse of opioid containing dosage forms
European Patent Office	2402004	Procédés et compositions permettant d'empêcher l'abus d'opioïde dans les formes galéniques (Methods and compositions for deterring abuse of opioid containing dosage forms)
Israel	175863	PHARMACEUTICAL COMPOSITIONS FOR DETERRING ABUSE OF OPIOID CONTAINING DOSAGE FORMS

Supplementary Protection Certificates for OXAYDO

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 OXAYDO: An In-Depth Analysis

Last updated: July 28, 2025

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Introduction

OXAYDO (oxycodone hydrochloride) is a prescription opioid analgesic marketed by Jazz Pharmaceuticals, primarily for managing moderate to severe pain. As a reformulation of oxycodone, OXAYDO aims to balance effective pain management with reduced abuse potential, responding to ongoing concerns about opioid misuse. Its market trajectory is influenced by evolving regulatory landscapes, shifting prescribing practices, reimbursement policies, and the broader societal response to the opioid epidemic. This article explores the current market dynamics and forecasts the financial trajectory of OXAYDO within the pharmaceutical landscape.

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Market Background and Positioning

Product Overview

OXAYDO is a reformulated oxycodone designed to deter abuse by making crushing or dissolving techniques more difficult. Approved by the FDA in 2013, OXAYDO positions itself as a safer alternative amid rising scrutiny over opioid dependency and abuse. Its formulation aims to retain analgesic effectiveness while mitigating misuse potential, a critical feature amid tightening regulatory controls [1].

Market Share and Competitive Landscape

Despite its notable formulation advances, OXAYDO's market share remains modest compared to major opioids like Purdue Pharma’s OXYCONTIN and other immediate-release oxycodone products. Key competitors include extended-release formulations (e.g., Xtampza ER, Purdue’s PCSS formulations) and abuse-deterrent products (e.g., Palladone, Embeda). The efficacy of OXAYDO’s abuse-deterrent properties has influenced prescriber confidence but has not entirely displaced established players [2].

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Regulatory and Legislative Influences

Regulatory Environment

The opioid crisis has prompted comprehensive regulatory responses. The FDA's REMS (Risk Evaluation and Mitigation Strategies) program mandates additional risk management, impacting product formulations and prescriber education. Abuse-deterrent formulations like OXAYDO are subject to ongoing assessment of their real-world effectiveness [3].

Legislative Impact

Legislation at federal and state levels increasingly emphasizes Prescription Drug Monitoring Programs (PDMPs) and prescribing limits. These measures limit opioid prescribing volumes, directly constraining OXAYDO’s sales. Conversely, targeted policies incentivize formulations with abuse-deterrent features, potentially favoring OXAYDO’s market position [4].

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Market Dynamics

Demand Drivers

• Chronic Pain Management: Growing prevalence of chronic pain conditions sustains demand for opioids, including abuse-deterrent variants.
• Pain Management Guidelines: Shifts favoring multimodal pain approaches challenge the traditional opioid-centric paradigm but still sustain opioid prescriptions in appropriate cases.
• Prescriber Preference: Increasing reliance on abuse-deterrent formulations influences prescribing behaviors, favoring products like OXAYDO when clinicians prioritize misuse mitigation.

Supply and Manufacturing Factors

• Manufacturing Challenges: Ensuring consistent formulation quality and abuse deterrence efficacy remains a priority for manufacturers.
• Supply Chain Stability: Global supply chain disruptions, notably during COVID-19, have temporarily affected product availability, influencing sales trajectories.

Market Constraints

• Abuse and Diversion Concerns: Despite reformulation efforts, illicit use and diversion continue to challenge market growth.
• Public and Regulatory Scrutiny: Calls for tighter controls or potential restrictions threaten OXAYDO's commercial viability.

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Financial Trajectory and Revenue Forecasts

Historical Financial Performance

Since its debut, OXAYDO's sales have experienced modest growth, constrained by factors such as prescriber hesitancy and regulatory restrictions. According to IQVIA data, OXAYDO's annual sales approximate several hundred million USD but have not exhibited exponential growth [5].

Forecasting Future Revenue

Projections suggest a stagnating or mildly upward trajectory over the next five years. Key factors influencing this outlook include:

• Market Penetration: Limited to specialized pain clinics and certain prescriber segments due to safety concerns and formulary restrictions.
• Pricing Strategies: Premium pricing aligned with abuse-deterrent technology sustains margins but can limit uptake.
• Competitive Dynamics: Entering or expanding within the abuse-deterrent opioid market will likely require differentiation and strategic marketing.

Impact of Regulatory Trends

Stricter opioid prescribing regulations could suppress volume growth. Conversely, incentives for abuse-deterrent formulations may sustain demand among clinicians seeking safer options.

Reimbursement and Insurance Coverage

Payers increasingly scrutinize opioid prescriptions. Prior authorization requirements, formulary placements, and cost-sharing influence utilization. OXAYDO’s continued adoption depends on payers’ recognition of its abuse-deterrent profile and overall cost-effectiveness [6].

Potential Market Expansion

Emerging markets and expanding chronic pain management protocols in developing regions offer incremental growth opportunities. However, regulatory challenges and differing healthcare infrastructures pose barriers.

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Market Challenges and Opportunities

Challenges

• Evolving Regulatory Landscape: Heightened restrictions may limit opportunities.
• Market Saturation with Abuse-Deterrent Formulations: Increasing competition dilutes OXAYDO's market share.
• Public Perception and Litigation Risks: Ongoing litigation related to opioid misuse impacts manufacturer reputation and could influence market dynamics.

Opportunities

• Enhanced Formulation and Delivery Methods: Innovation can improve efficacy and safety, boosting market appeal.
• Strategic Partnerships: Collaborations with healthcare providers and payers can facilitate adoption.
• Global Expansion: Penetrating international markets with regulatory pathways for abuse-deterrent opioids can diversify revenue sources.

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Conclusion

The market dynamics surrounding OXAYDO are characterized by a complex interplay of regulatory oversight, societal pressures, technological innovation, and evolving prescribing behaviors. While abuse-deterrent formulations maintain their relevance, the overall market growth for OXAYDO faces headwinds from tighter regulations, public scrutiny, and competitive pressures. Financial forecasts indicate moderate, steady revenue trajectories with potential for expansion through targeted strategies and market diversification.

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Key Takeaways

• OXAYDO's unique abuse-deterrent properties position it favorably in a cautious opioid market but limit rapid growth potential.
• Regulatory and legislative measures significantly influence prescribing patterns and sales volumes of abuse-deterrent opioids.
• Market opportunities exist in expanding international markets and innovating formulations, though barriers persist.
• Payer policies and insurance coverage critically impact OXAYDO’s financial trajectory.
• Strategic stakeholder engagement and continuous innovation are vital for sustaining and enhancing market performance.

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FAQs

1. How does OXAYDO differ from other oxycodone formulations?
OXAYDO features a proprietary abuse-deterrent formulation designed to resist crushing and dissolution, aiming to reduce misuse potential compared to traditional oxycodone products.

2. What regulatory challenges does OXAYDO face?
Regulatory focuses on opioid misuse mitigation lead to stringent oversight, REMS compliance, and potential restrictions that can limit market access and prescribing.

3. Can OXAYDO significantly grow in the current opioid landscape?
Growth is limited due to regulatory constraints, societal concerns, and competition from other abuse-deterrent opioids, but niche markets and strategic expansion can sustain sales.

4. What role do insurers play in OXAYDO’s market success?
Insurance coverage influences prescribing by determining formulary placement and reimbursement levels; favorable coverage enhances availability and utilization.

5. Are there emerging markets for OXAYDO?
Yes, international markets with evolving regulations and pain management protocols present opportunities, though they require navigating local approval processes and market acceptance.

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References

[1] FDA. (2013). FDA approves reformulation of OxyContin to deter abuse.
[2] IQVIA. (2022). Pharmacovigilance and Market Reports.
[3] FDA. (2021). REMS program for opioid analgesics.
[4] CDC. (2020). Prescribing guidelines and legislative updates.
[5] MarketWatch. (2022). OXAYDO sales and market share analysis.
[6] Milliman. (2021). Payer policies and opioid reimbursement trends.