OXTELLAR XR Drug Patent Profile

When do Oxtellar Xr patents expire, and what generic alternatives are available?

Oxtellar Xr is a drug marketed by Supernus Pharms and is included in one NDA. There are eleven patents protecting this drug and two Paragraph IV challenges.

This drug has fourteen patent family members in ten countries.

The generic ingredient in OXTELLAR XR is oxcarbazepine. There are twenty-one drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oxtellar Xr

A generic version of OXTELLAR XR was approved as oxcarbazepine by GLENMARK PHARMS LTD on October 9^th, 2007.

Summary for OXTELLAR XR

International Patents:	14
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	3
Patent Applications:	6,777
Drug Prices:	Drug price information for OXTELLAR XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OXTELLAR XR
What excipients (inactive ingredients) are in OXTELLAR XR?	OXTELLAR XR excipients list
DailyMed Link:	OXTELLAR XR at DailyMed

See drug prices for OXTELLAR XR

Recent Clinical Trials for OXTELLAR XR

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

Sponsor	Phase
University of Colorado, Denver	Phase 4
Collaborative Care Initiative, LLC	Phase 4
Dauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen Hospital	Phase 4

See all OXTELLAR XR clinical trials

Pharmacology for OXTELLAR XR

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for OXTELLAR XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OXTELLAR XR	Extended-release Tablets	oxcarbazepine	150 mg and 300 mg	202810	1	2013-04-12
OXTELLAR XR	Extended-release Tablets	oxcarbazepine	600 mg	202810	1	2013-03-20

US Patents and Regulatory Information for OXTELLAR XR

OXTELLAR XR is protected by eleven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes			Y
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes			Y
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes			Y
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes			Y

International Patents for OXTELLAR XR

See the table below for patents covering OXTELLAR XR around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2013079267	CONTROLLED RELEASED PREPARATION OF OXCARBAZEPINE HAVING SIGMOIDAL RELEASE PROFILE
European Patent Office	2359830	Préparations à libération contrôlée d'oxcarbazépine disposant d'un profil à libération sigmoïdale (Controlled released preparations of oxcarbazepine having sigmoidal release profile)
Japan	5253381
Austria	E496623

Market Dynamics and Financial Trajectory for OXTELLAR XR

Last updated: July 27, 2025

Introduction

OXTELLAR XR (oxycodone extended-release), a prescription opioid analgesic, has carved out a vital role in managing moderate to severe chronic pain. As the market landscape for opioid-based therapies evolves, understanding the current and projected financial trajectory of OXTELLAR XR becomes crucial for industry stakeholders, healthcare providers, and policymakers. This analysis examines key market dynamics, regulatory influences, competitive positioning, and financial forecasts that shape OXTELLAR XR’s future.

Market Overview and Therapeutic Positioning

OXTELLAR XR operates as an extended-release formulation of oxycodone, a potent opioid analgesic approved by U.S. FDA in 2014. Its primary market includes adult patients requiring long-term pain control—particularly those with cancer pain, severe injury, or chronic pain conditions where sustained analgesia is essential. The global opioid medications market, valued at approximately USD 9.3 billion in 2021, is projected to expand at a compound annual growth rate (CAGR) of 3-5% over the next five years, driven by escalating incidences of chronic pain and refined delivery systems.

OXTELLAR XR differentiates itself with its controlled-release technology, purportedly offering consistent plasma levels and reduced dosing frequency. This positioning enables higher compliance, but also places it within a highly scrutinized market environment due to the opioid crisis.

Regulatory and Legal Environment

Regulatory scrutiny profoundly influences OXTELLAR XR’s market trajectory. The opioid epidemic has prompted tighter controls and heightened oversight by agencies like the U.S. FDA and DEA. Manufacturers face increased pressure through stricter prescribing guidelines, abuse-deterrent formulations, and possible litigation stemming from overprescription issues.

In 2021, the FDA issued new REMS (Risk Evaluation and Mitigation Strategies) for extended-release and long-acting opioids to mitigate abuse risk. OXTELLAR XR, like other products in its class, must adhere to these evolving regulations, which could limit prescribing or increase compliance costs, impacting sales and profitability.

Market Dynamics and Competitive Landscape

Market Drivers

• Growing Pain Prevalence: Aging populations and rising chronic disease prevalence bolster demand.
• Advancements in Delivery Technology: Enhanced formulations and abuse-deterrent features improve safety profiles, supporting market acceptance.
• Healthcare Policy Shift: Increasing importance of long-acting opioids for chronic pain management sustains demand, albeit with caution due to addiction concerns.

Market Challenges

• Abuse and Misuse Concerns: Heightened societal and regulatory focus on opioid abuse affects market acceptance and patient access.
• Generic Competition: Several generic oxycodone ER formulations enjoy market share, pressuring prices of branded products like OXTELLAR XR.
• Alternative Therapies: Non-opioid pain management options, including gabapentinoids, NSAIDs, and emerging biologics, threaten long-term growth.

Competitive Positioning

OXTELLAR XR competes primarily with other branded opioids such as Purdue Pharma’s OxyContin, and generics manufactured by multiple players. Its success hinges on formulary positioning, prescriber acceptance, and demonstration of superior safety profiles through abuse-deterrent formulations.

Financial Trajectory and Growth Outlook

Revenue Streams

OXTELLAR XR’s revenue derives from direct sales to hospitals, clinics, and pharmacies, alongside licensing and distribution agreements. Its launch phase has shown variability based on regulatory shifts, prescribing trends, and payer reimbursement policies.

Historical Performance and Projections

Since launch, OXTELLAR XR’s sales growth has been moderated by regulatory constraints and competitive pressures, with an initial peak followed by stabilization. Analysts forecast a moderate CAGR of 2-4% through 2027, contingent on:

• Market Penetration: Increasing physician familiarity and formulary inclusions.
• Pricing Strategies: Maintaining premium positioning through safety and convenience features.
• Regulatory Navigations: Sustained compliance and proactive engagement with authorities to avoid restrictions.

Impact of Global and Local Market Factors

In the U.S., the opioid crisis has constrained growth prospects but also fostered efforts in abuse-deterrent technology, which can support premium pricing. International markets, such as Europe and Asia, present emerging opportunities but face differing regulatory and cultural barriers.

Revenue Risks and Opportunities

• Risks: Stringent prescribing limits, potential legal liabilities, and the rise of non-opioid therapies.
• Opportunities: Innovative formulations, combination therapies, and expansion into novel pain indications can drive future revenues.

Emerging Trends Influencing Financial Trajectory

• Digital Health Integration: Use of telemedicine and digital monitoring could optimize prescribing and adherence, potentially expanding market share.
• Policy Shifts: Moves toward re-evaluating opioid prescribing frameworks, including Prescription Drug Monitoring Programs (PDMPs), influence dispensing patterns.
• Research & Development: Investment in abuse-resistant formulations and non-addictive alternatives may alter competitive positioning and market size.

Conclusion

OXTELLAR XR’s market and financial growth trajectory is shaped by a complex interrelation of regulatory pressures, evolving prescribing habits, and competitive dynamics. While near-term prospects face headwinds from societal concerns over opioid misuse, long-term growth hinges on technological innovations, safety features, and strategic market positioning. Participants must balance potential revenue gains with the inherent risks associated with opioid management and regulatory compliance.

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Key Takeaways

• Market stability for OXTELLAR XR depends on navigating regulatory environments and differentiating through safety and abuse-deterrent features.
• Growth prospects remain moderate due to competition from generics, societal opioid restrictions, and alternative therapies.
• Innovation in abuse-resistant formulations offers pathways to maintain premium pricing and expand market share.
• International expansion could diversify revenue streams but requires addressing distinct regulatory landscapes.
• Stakeholders must prioritize compliance and advocate for balanced policies to sustain profitability amid declining societal tolerance for opioids.

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FAQs

1. How does OXTELLAR XR differ from other extended-release oxycodone formulations?
OXTELLAR XR utilizes advanced abuse-deterrent technology and sustained-release mechanisms designed to improve safety and compliance, making it potentially more resistant to misuse compared to traditional formulations.

2. What regulatory challenges could impact the sales of OXTELLAR XR?
Stringent prescribing guidelines, REMS requirements, and potential litigation associated with opioids can restrict access, increase compliance costs, and influence market acceptance.

3. What are the main factors influencing OXTELLAR XR's revenue growth?
Market acceptance by prescribers, reimbursement policies, competitive pressures, and technological innovations are primary drivers affecting its revenue trajectory.

4. Are there any international opportunities for OXTELLAR XR?
Yes, markets like Europe and Asia offer growth prospects, but they require navigating diverse regulatory environments and cultural perceptions of opioid use.

5. How might the opioid crisis influence the future of OXTELLAR XR?
Heightened awareness and regulatory response to the opioid epidemic could limit growth, but innovations like abuse-deterrent features may help sustain demand among appropriate patient populations.

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References

[1] MarketWatch, “Global Opioid Medications Market,” 2021.
[2] U.S. Food and Drug Administration, “Opioid Analgesic REMS,” 2021.
[3] Grand View Research, “Pain Management Market Size & Trends,” 2022.