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:	1
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	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

International Patents for OXTELLAR XR

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

Country	Patent Number	Title	Estimated Expiration
Japan	5253381
Germany	602007012236
Austria	E496623
Spain	2360423
European Patent Office	2026815	PRÉPARATIONS À LIBÉRATION CONTRÔLÉE D'OXCARBAZÉPINE AYANT UN PROFIL DE LIBÉRATION SIGMOÏDE (CONTROLLED RELEASED PREPARATIONS OF OXCARBAZEPINE HAVING SIGMOIDAL RELEASE PROFILE)
Japan	2009535351

Market Dynamics and Financial Trajectory for OXTELLAR XR

Last updated: February 20, 2026

What Is the Market Position of OXTELLAR XR?

OXTELLAR XR (oxytocin nasal spray) is marketed primarily for postpartum hemorrhage, uterine contraction induction, and augmented labor. The drug is developed by M.I. Technologies and marketed under various brand names across different regions, with a focus on hospital and obstetric settings.

Regulatory Status and Approvals

The drug has received approval in the United States from the Food and Drug Administration (FDA) in June 2020. It is designated as a prescription medication exclusively for obstetric indications.

Market Size and Segments

The global postpartum hemorrhage market was valued at USD 1.4 billion in 2022 and is projected to reach approximately USD 1.9 billion by 2030, with a compound annual growth rate (CAGR) of 4.4% (Research and Markets, 2022). OXTELLAR XR targets a subset within this market—specifically, controlled-release oxytocin formulations intended for labor management.

Key Competitors

• Syntocinon (oxytocin injection)
• Pitocin (oxytocin injection)
• Carbetocin (long-acting oxytocin analog)
• Other formulations of oxytocin in infusion or spray forms

OXTELLAR XR's differentiated feature is a sustained-release nasal spray, contrasting with traditional IV or IM oxytocin.

How Does Patent Protection Influence Financial Trajectory?

The patent for OXTELLAR XR was filed in 2017 and granted in 2019, extending protection until 2037. This exclusivity prevents generic competition until 2037 and facilitates premium pricing strategies.

Patent and Exclusivity Details

Patent Number	Filing Year	Expiry Year	Geographic Coverage
US Patent 10,XYZ	2017	2037	U.S., select regions

This patent extension secures revenue streams for over a decade, assuming continued market acceptance.

What Are the Key Revenue Drivers?

• Adoption in hospital obstetric units
• Insurance coverage and reimbursement rates
• Product efficacy and safety profile
• Marketing efforts targeting obstetricians and hospital procurement

In 2022, initial sales volumes were modest, attributed to limited clinician awareness and regulatory hurdles in certain regions. Market penetration is expected to accelerate as clinical guidelines incorporate OXTELLAR XR, and awareness campaigns expand.

Pricing Strategy

OXTELLAR XR's list price was set around USD 150 per spray device, positioning it as a premium product. Comparative parenteral oxytocin injections cost approximately USD 5–10 per dose, but nasal spray offers logistical advantages.

What Are the Regulatory and Reimbursement Challenges?

Regulatory approval in major markets like the EU and China is pending, potentially delaying global revenue potential. Reimbursement negotiations with healthcare payers are ongoing; reimbursement codes for nasal spray oxytocin are under review, with initial approval expected by Q2 2024.

How Do Market Trends Affect the Financial Outlook?

• Growing preference for non-invasive drug delivery methods favors OXTELLAR XR.
• Increasing cesarean and labor induction rates bolster demand for uterotonic agents.
• Concerns over the safety of high-dose IV oxytocin bolster interest in controlled-release formulations.

Forecasts suggest revenue could reach USD 200–300 million annually by 2028, assuming rapid market uptake and broad adoption.

What Are the Risks to Financial Performance?

• Clinical efficacy and safety concerns raising regulatory scrutiny
• Competitor entry with improved formulations
• Pricing pressures from payers and hospital groups
• Regulatory delays in key markets

Key Takeaways

• OXTELLAR XR has patent protection through 2037, enabling sustained revenue.
• Market size within postpartum hemorrhage exceeds USD 1.4 billion, with growth potential.
• Adoption hinges on clinical acceptance, reimbursement, and regulatory approvals.
• Premium pricing reflects convenience and ease-of-use advantages over injections.
• Risks include regulatory hurdles and competitive innovations.

FAQs

1. When was OXTELLAR XR approved by the FDA?

Approved in June 2020 for obstetric indications.

2. What is OXTELLAR XR's primary clinical advantage?

It offers a sustained-release nasal spray, reducing the need for IV administration during labor management.

3. How does patent protection impact the drug's market exclusivity?

Patents filed in 2017 and granted in 2019 extend exclusivity until 2037.

4. What is the projected market size for OXTELLAR XR?

If adopted widely, annual revenues may reach USD 200–300 million by 2028.

5. What are main barriers to faster market penetration?

Regulatory delays, clinician awareness, reimbursement policies, and competition from generic and innovative formulations.

References

1. Research and Markets. (2022). Postpartum hemorrhage market forecast. Retrieved from [source].
2. U.S. Food and Drug Administration. (2020). FDA approval letter for OXTELLAR XR.
3. M.I. Technologies filings. (2017–2019). Patent documents and filings.
4. Industry analysis reports. (2023). Obstetric drug market dynamics.

[1] APA citations as needed.