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. Thirty-five 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:	131
Clinical Trials:	3
Patent Applications:	5,173
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
Dauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen Hospital	Phase 4
Collaborative Care Initiative, LLC	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	8,617,600		Y
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes	11,166,960		Y
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes	11,896,599		Y
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes	7,722,898		Y
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-001	Oct 19, 2012	AB	RX	Yes	No	10,220,042
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-002	Oct 19, 2012	AB	RX	Yes	No	9,370,525		Y
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes	9,119,791

International Patents for OXTELLAR XR

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

Country	Patent Number	Title	Estimated Expiration
Japan	2009535351
Spain	2396051
Canada	2597740	PREPARATIONS A LIBERATION MODIFIEE CONTENANT DE L'OXCARBAZEPINE ET SES DERIVES (MODIFIED-RELEASE PREPARATIONS CONTAINING OXCARBAZEPINE AND DERIVATIVES THEREOF)
Spain	2360423
Mexico	2008013675	PREPARACIONES DE LIBERACION CONTROLADA DE OXCARBACEPINA QUE TIENEN PERFIL DE LIBERACION SIGMOIDAL. (CONTROLLED RELEASED PREPARATIONS OF OXCARBAZEPINE HAVING SIGMOIDAL RELEASE PROFILE.)
Austria	E496623
Japan	5253381

OXTELLAR XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxtellar XR

Introduction to Oxtellar XR

Oxtellar XR, developed by Supernus Pharmaceuticals, Inc., is a novel, oral once-daily extended-release formulation of oxcarbazepine. It is approved for the treatment of partial-onset seizures in patients 6 years of age and older. The drug is available in 150mg, 300mg, and 600mg extended-release tablets[1].

Regulatory Milestones

A significant regulatory milestone for Oxtellar XR was the FDA approval of the supplemental New Drug Application (sNDA) to expand its indication to include monotherapy for partial-onset seizures. This approval, received in December 2018, marked a crucial expansion of the drug's market potential beyond its initial adjunctive therapy indication[1].

Market Position and Competition

Oxtellar XR operates within the epilepsy treatment market, which is characterized by a mix of branded and generic products. The global oxcarbazepine market, which includes Oxtellar XR, is expected to grow at a CAGR of 5.5% from 2022 to 2030, driven by increasing demand for effective epilepsy treatments[4].

Financial Performance

Revenue Growth

Oxtellar XR has contributed significantly to Supernus Pharmaceuticals' revenue growth. In the second quarter of 2024, net product sales of Oxtellar XR increased, contributing to a 32% rise in total revenues excluding Trokendi XR and Oxtellar XR, compared to the same period in 2023[2].

For the full year 2023, Oxtellar XR net sales were $113 million, which was essentially stable compared to 2022. This stability is notable given the decline in sales of other products like Trokendi XR due to generic erosion[3].

Quarterly and Annual Financial Highlights

• In the third quarter of 2024, total revenues for Supernus Pharmaceuticals were $175.7 million, with a 14% increase compared to the same period in 2023. Oxtellar XR net product sales remained relatively stable, with a slight increase of 1% compared to the third quarter of 2023[5].
• For the nine months ended September 30, 2024, total revenues were $487.7 million, a 10% increase from the same period in 2023. Oxtellar XR net product sales for this period were $86.3 million, a 5% increase from the previous year[5].

Operational Earnings and Adjustments

The financial performance of Oxtellar XR is also reflected in Supernus Pharmaceuticals' operating earnings. In the third quarter of 2024, operating earnings were $40.9 million, a significant improvement from the operating loss of $8.1 million in the same period in 2023. Adjusted operating earnings (non-GAAP) for the nine months ended September 30, 2024, were $135.4 million, up from $77.9 million in the same period in 2023[5].

Impact of Generic Erosion

While Oxtellar XR has maintained stable sales, the company has faced challenges from generic erosion, particularly with Trokendi XR. However, the growth of other products like Qelbree and GOCOVRI has helped mitigate these losses. For instance, in 2023, the combined net sales of Qelbree and GOCOVRI exceeded $260 million, significantly offsetting the decline in Trokendi XR sales[3].

Market Expansion and Growth Opportunities

The expansion of Oxtellar XR's indication to include monotherapy has opened up additional growth opportunities. As stated by Supernus Pharmaceuticals, "We believe that expanding the indication to include monotherapy represents an additional growth opportunity for Oxtellar XR"[1].

Future Outlook

Supernus Pharmaceuticals is optimistic about the future performance of Oxtellar XR, along with its other growth products. The company is focusing on transitioning from mature brands to newer products and has a robust pipeline of emerging CNS product candidates. This strategic shift is expected to drive continued growth and mitigate the impact of generic competition[3].

Key Statistics and Trends

• Revenue Growth: Total revenues excluding Trokendi XR and Oxtellar XR net product sales (non-GAAP) increased by 26% and 23% for the three and nine months ended September 30, 2024, respectively[5].
• Market Share: The global oxcarbazepine market is expected to grow at a CAGR of 5.5% from 2022 to 2030, indicating a favorable market environment for Oxtellar XR[4].
• Prescription Trends: The stability in Oxtellar XR sales despite generic erosion in other products highlights its strong market position and prescription loyalty[3].

Expert Insights and Quotes

"We are pleased with the timely approval of the expanded indication for Oxtellar XR. We look forward to launching Oxtellar XR in the first quarter 2019 as a new monotherapy treatment option for partial-onset seizures," said a representative from Supernus Pharmaceuticals, reflecting the company's optimism about the drug's potential[1].

Highlight and Citation

"The global oxcarbazepine market is expected to grow at a CAGR of 5.5% from 2022 to 2030. The growth in the market can be attributed to the increasing demand for effective epilepsy treatments." - DataIntelo Report[4]

Key Takeaways

• Regulatory Approval: Oxtellar XR received FDA approval for monotherapy treatment of partial-onset seizures, expanding its market potential.
• Revenue Stability: Despite generic erosion in other products, Oxtellar XR has maintained stable sales.
• Growth Opportunities: The expansion of its indication and strong market position offer additional growth opportunities.
• Financial Performance: Oxtellar XR has contributed significantly to Supernus Pharmaceuticals' revenue and operating earnings growth.
• Market Trends: The global oxcarbazepine market is expected to grow, supporting Oxtellar XR's future prospects.

Frequently Asked Questions (FAQs)

Q: What is Oxtellar XR used for? A: Oxtellar XR is used for the treatment of partial-onset seizures in patients 6 years of age and older, both as adjunctive therapy and as monotherapy.

Q: What was the significant regulatory milestone for Oxtellar XR? A: The FDA approval of the sNDA to expand its indication to include monotherapy for partial-onset seizures in December 2018.

Q: How has Oxtellar XR performed financially? A: Oxtellar XR has contributed to Supernus Pharmaceuticals' revenue growth, with stable sales despite generic erosion in other products.

Q: What are the future growth prospects for Oxtellar XR? A: The expansion of its indication and the company's focus on transitioning to newer products are expected to drive continued growth.

Q: How does Oxtellar XR fit into the global oxcarbazepine market? A: The global oxcarbazepine market is expected to grow at a CAGR of 5.5% from 2022 to 2030, providing a favorable market environment for Oxtellar XR.

Sources Cited

1. Supernus Announces FDA Approval of sNDA to Expand Oxtellar XR Label to Include Monotherapy - Supernus Pharmaceuticals, Inc.
2. Supernus Announces Second Quarter 2024 Financial Results - Supernus Pharmaceuticals, Inc.
3. Dear Supernus Stockholder - Supernus Pharmaceuticals, Inc.
4. Oxcarbazepine Market Report | Global Forecast From 2023 To 2032 - DataIntelo
5. Supernus Announces Third Quarter 2024 Financial Results - GlobeNewswire