OXAYDO Drug Patent Profile

Which patents cover Oxaydo, and when can generic versions of Oxaydo launch?

Oxaydo is a drug marketed by Zyla and is included in one NDA. There are two patents 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-three 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:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	1
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 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
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011		DISCN	Yes	No			Y
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011		DISCN	Yes	No			Y
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011		DISCN	Yes	No			Y
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011		DISCN	Yes	No			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
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011

International Patents for OXAYDO

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

Country	Patent Number	Title	Estimated Expiration
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
Australia	2013206525	Methods and compositions for deterring abuse of opioid containing dosage forms
Australia	2004294953	Methods and compositions for deterring abuse of opioid containing dosage forms
Australia	2015264950	Methods and compositions for deterring abuse of opioid containing dosage forms
World Intellectual Property Organization (WIPO)	2005053587

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

OXAYDO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OXAYDO

Introduction

OXAYDO, a formulation of oxycodone hydrochloride, is a potent opioid analgesic used for the management of acute and chronic pain. Understanding the market dynamics and financial trajectory of OXAYDO is crucial for pharmaceutical companies, investors, and healthcare professionals.

Indications and Usage

OXAYDO is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic, particularly when alternative treatments are inadequate. This includes patients who have not tolerated or received adequate analgesia from non-opioid analgesics or other opioid combination products[4].

Market Size and Demand

The demand for opioid analgesics like OXAYDO is influenced by several factors, including the prevalence of chronic pain, the number of prescriptions, and the illicit opioid market. In the EU, for example, there was an estimated 1 million high-risk opioid users among adults in 2021, with significant variation between countries[1].

Prescription Trends

There has been a notable increase in opioid prescriptions over the years. In the Netherlands, opioid prescriptions rose by 80% between 2008 and 2017, with oxycodone prescriptions increasing by 350% during the same period. This trend is mirrored in other regions, including the United States, where prescription opioids have contributed to the opioid epidemic[1].

Impact of Illicit Markets

The increase in prescription opioids can affect the illicit market, as individuals dependent on prescription medications may turn to illicit sources when their prescriptions expire or are insufficient. This dynamic can influence the overall demand and pricing of opioids like OXAYDO[1].

Safety and Regulatory Considerations

OXAYDO, like other opioids, carries significant risks of addiction, abuse, and misuse. Regulatory bodies and healthcare providers must carefully manage these risks through proper dosing, titration, and patient monitoring. The FDA and other regulatory agencies have stringent guidelines for the prescription and use of OXAYDO, which can impact its market trajectory[2][4].

Competitive Landscape

The opioid market is competitive, with various formulations and brands available. OXAYDO's unique formulation, which includes features like robust resistance to preparation for injection, can differentiate it from competitors. However, the overall market is dominated by a few key players, and new entrants must navigate this competitive landscape carefully[5].

Financial Performance

The financial performance of OXAYDO is tied to several factors, including sales volume, pricing, and regulatory approvals. Drugs with higher comparative clinical benefit scores tend to have higher early market sales. For opioids, the market reward is significant, but it is also subject to stringent regulatory oversight and public health concerns[3].

Sales and Revenue

The sales of OXAYDO are influenced by its clinical benefit, patient demand, and competition. While specific revenue figures for OXAYDO are not publicly available, the overall opioid market is substantial. For instance, the cumulative nine-quarter sales for high-ranking oncology drugs, which are often used as a benchmark for other therapeutic areas, can reach over $1 billion. However, opioids typically have lower sales figures compared to oncology drugs but still represent a significant market segment[3].

Development and Approval Costs

The development and approval costs for opioid drugs like OXAYDO are considerable but generally lower than those for oncology or antimicrobial drugs. The average capitalized development and approval costs for antimicrobial drugs, for example, are significantly higher than those for opioids, which can make opioids a more attractive investment in terms of cost-benefit analysis[3].

Patient and Healthcare Provider Perspectives

Patient and healthcare provider perspectives play a crucial role in the market dynamics of OXAYDO. Patients require effective pain management, and healthcare providers must balance this need with the risks associated with opioid use. The conservative approach advised in dosing and the need for close patient monitoring can influence prescribing patterns and patient adherence[2][4].

Regulatory Environment

The regulatory environment is a critical factor in the market trajectory of OXAYDO. Regulatory bodies impose strict guidelines to mitigate the risks of addiction and misuse. Compliance with these regulations is essential for maintaining market approval and ensuring patient safety[2][4].

Future Outlook

The future outlook for OXAYDO is complex and influenced by multiple factors. As the opioid epidemic continues to be a public health concern, there may be increased scrutiny and regulation of opioid prescriptions. However, the ongoing need for effective pain management ensures a continued demand for opioids like OXAYDO.

Innovations and Formulations

Innovations in opioid formulations, such as abuse-deterrent technologies, can enhance the market position of OXAYDO. These technologies, which make it harder to misuse opioids, are increasingly favored by regulatory bodies and can provide a competitive edge[5].

Public Health Initiatives

Public health initiatives aimed at reducing opioid misuse can impact the market dynamics of OXAYDO. These initiatives may include stricter prescribing guidelines, increased access to treatment for opioid use disorders, and public awareness campaigns. While these efforts are crucial for public health, they can also affect the sales and revenue of opioid medications[1].

Key Takeaways

• Market Demand: Driven by chronic pain prevalence and prescription trends.
• Regulatory Oversight: Strict guidelines to mitigate risks of addiction and misuse.
• Competitive Landscape: Differentiation through unique formulations and safety features.
• Financial Performance: Influenced by sales volume, pricing, and regulatory approvals.
• Future Outlook: Shaped by public health initiatives, regulatory environment, and innovations in formulations.

FAQs

What are the primary indications for OXAYDO?

OXAYDO is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic, particularly when alternative treatments are inadequate[4].

What are the risks associated with OXAYDO?

OXAYDO carries significant risks of addiction, abuse, and misuse, as well as serious side effects such as respiratory depression and neonatal opioid withdrawal syndrome[2][4].

How does the regulatory environment impact OXAYDO?

The regulatory environment imposes strict guidelines to mitigate the risks associated with opioid use. Compliance with these regulations is essential for maintaining market approval and ensuring patient safety[2][4].

What is the competitive landscape for OXAYDO?

The opioid market is competitive, with various formulations and brands available. OXAYDO's unique features, such as its resistance to preparation for injection, can differentiate it from competitors[5].

What are the future outlook and challenges for OXAYDO?

The future outlook is influenced by public health initiatives, regulatory oversight, and innovations in formulations. Challenges include balancing the need for effective pain management with the risks of opioid misuse and the impact of regulatory changes on market dynamics[1][3][5].

Sources

1. EU Drug Market: Heroin and other opioids — Retail markets - EUDA
2. OXAYDO® (oxycodone HCl) tablets for oral use only - FDA
3. Antimicrobial drugs market returns analysis final - ASPE
4. Oxaydo: Package Insert / Prescribing Information - Drugs.com
5. PAINWeek Abstract Book 2016 - Tandfonline.com