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-four 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:	7,678
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			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
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-001	Oct 19, 2012	AB	RX	Yes	No
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-002	Oct 19, 2012	AB	RX	Yes	No			Y

International Patents for OXTELLAR XR

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

Country	Patent Number	Title	Estimated Expiration
Austria	E496623
Australia	2007242984	Controlled released preparations of oxcarbazepine having sigmoidal release profile
Canada	2597740	PREPARATIONS A LIBERATION MODIFIEE CONTENANT DE L'OXCARBAZEPINE ET SES DERIVES (MODIFIED-RELEASE PREPARATIONS CONTAINING OXCARBAZEPINE AND DERIVATIVES THEREOF)
China	101489560	Controlled released preparations of oxcarbazepine having sigmoidal release profile
Germany	602007012236
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)

OXTELLAR XR (oxcarbazepine extended-release) Market Dynamics and Financial Trajectory (U.S.)

Last updated: July 23, 2026

Oxtellar XR is the U.S. extended-release (ER) formulation of oxcarbazepine. The product’s market dynamics are shaped by (i) patent and exclusivity driven supply constraints, (ii) competitive substitution across oxcarbazepine IR and branded/authorized ER alternatives, and (iii) insurer formulary positioning for partial-onset seizures. Financial trajectory is primarily a function of U.S. net sales momentum post-launch, penetration of managed-care formularies, and erosion risk as pricing pressure increases with generic entry and channel mix shifts.

What is the market positioning of OXTELLAR XR (oxcarbazepine ER) versus other oxcarbazepine products?

Oxtellar XR operates in the antiseizure market segment for focal (partial-onset) seizures. Its differentiation is the ER dosing schedule and the specific pharmacokinetic profile delivered by the Oxtellar XR formulation. In practice, payer substitution pressure typically centers on class and molecule-level interchangeability (oxcarbazepine across dosage forms) and on cost minimization strategies within managed formularies.

How does ER dosing affect prescribing and formulary placement?

• ER characteristics can support adherence and caregiver/schedule simplicity, which can matter in formulary decisions when prescribers and patients have demonstrated stability on a given dosing regimen.
• Payer committees often evaluate ER vs IR primarily on total daily cost and clinical differentiation claims. If clinical value is not captured in payer criteria, branded ER demand can convert quickly to cheaper substitutes.

What competitive substitution exists against Oxtellar XR?

Competitive dynamics for Oxtellar XR typically include:

• Oxcarbazepine IR generics used under formulary preferred tiering.
• Other ER antiseizure products that compete indirectly for the same patient population and neurologist prescribing mindshare, especially when payers favor lower net-cost products.

How do patent expiration, exclusivity, and generic entry risks affect OXTELLAR XR sales?

Oxtellar XR’s financial trajectory depends on the timing and strength of its IP wall and the speed of generic competitive supply once barriers drop. In antiseizure brands, sales erosion usually accelerates after:

1. the branded product loses exclusivity or the effective barriers are cleared, and
2. multiple generic manufacturers launch and drive net price compression.

What typically triggers rapid erosion for antiseizure brands?

• Multiple ANDA launches that increase supply and increase pharmacy benefit manager (PBM) leverage.
• Contracting and rebate renegotiations that shift OOP costs and tier placement.
• Switch-to-generic protocols and prescriber education by payers.

How do settlement agreements and licensing deals change the timing of erosion?

Where settlements exist, they can:

• Delay generic launch dates.
• Limit which generic strengths or dosing forms can be marketed during the stay period.
• Create “design-around” exposure if a settlement covers only specific formulations or methods.

When does OXTELLAR XR lose exclusivity and how does that map to revenue exposure?

A product-level financial model usually ties revenue to three timelines:

• exclusivity expiration (regulatory and market exclusivity),
• patent expiration (with litigation outcomes determining actual launch timing), and
• generic uptake (which can occur quickly after launch, but often depends on payer contracting and prescribing behavior).

Because your request is limited to “market dynamics and financial trajectory,” a full exclusivity-and-expiration table cannot be produced without a verified Orange Book and litigation record for Oxtellar XR in the specific U.S. listed strengths. Under the constraints here, a complete, accurate expiration mapping cannot be generated.

What is the Orange Book status of OXTELLAR XR and how does it influence generic risk?

Orange Book status drives:

• where Paragraph IV challenges may exist,
• whether listed patents are composition, method-of-use, or formulation, and
• whether generic entry is blocked in whole or in part.

A complete Orange Book status analysis requires the exact Orange Book listings for each strength and dosage form, including patent numbers and listed expiration dates. Those listings are not provided in the prompt and cannot be reconstructed reliably without direct source data in this environment.

What generic entry risks exist for OXTELLAR XR and how fast could substitution occur?

For branded ER antiseizure products, substitution velocity after generic entry often follows PBM channel mechanics:

• Rapid conversion at retail pharmacies if the branded product is moved to non-preferred tiers.
• Faster neurologist acceptance if clinical stability does not substantially differ between ER oxcarbazepine products and prescribers view the generic ER profile as interchangeable.
• Slower adoption if specific patient populations show sensitivity to excipients, device/formulation attributes, or therapeutic drug monitoring differences.

Because this is molecule- and dosage-form specific, the substitution speed depends on:

• whether the generic launched is ER-equivalent and labeled with the same dosing regimen, and
• the number of authorized competitors available at launch.

A quantified launch scenario and adoption curve cannot be provided without the product-specific generic lineup and FDA approvals.

How does OXTELLAR XR compare commercially with other antiseizure brands on price, payer adoption, and channel mix?

Oxtellar XR’s commercial performance in the antiseizure market is shaped by standard brand economics:

• higher gross-to-net due to rebates and contracting, and
• payer-driven channel mix where neurologists’ preferences interact with plan formularies.

Key business levers affecting sales:

• formulary tier placement (preferred vs non-preferred),
• prior authorization and step therapy rules,
• net pricing versus competitors (especially within oxcarbazepine ER vs generic ER or IR substitution),
• persistence and dose titration adherence.

Oxtellar XR’s financial trajectory typically improves when:

• it retains preferred status through multiple plan-year cycles, and
• it maintains stable prescriber use through therapy lines (new starts and switches).

It typically declines when:

• the brand is displaced in formularies by lower net-cost alternatives, or
• competing ER offerings capture the same patient segment and PBMs steer utilization.

What litigation and settlement events have affected OXTELLAR XR sales timing?

Generic erosion often depends on the presence and outcome of:

• patent infringement actions tied to ANDA approvals,
• Paragraph IV litigation timelines,
• automatic stays based on first-to-file status, and
• settlement agreements that define a launch calendar.

A litigation timeline for Oxtellar XR cannot be compiled here without verified case identifiers, dismissal/stay orders, and settlement dates tied to the exact Orange Book-listed patents for each marketed strength. Generating such a timeline without source-backed data would risk material error.

What is the FDA regulatory and labeling context for OXTELLAR XR that drives commercial uptake?

Oxtellar XR is approved for focal (partial-onset) seizures. Labeling scope influences commercial reach:

• indicated populations,
• contraindications and monitoring requirements, and
• dosing titration and persistence.

Commercial uptake accelerates when:

• dosing is aligned with common clinical workflows,
• safety profiles are manageable under typical monitoring practices, and
• payer policies do not restrict use beyond label.

Quantitative market-share outcomes are not deliverable without sales and prescription datasets by channel and plan type, which are not included in the prompt.

What are the most important market-dynamics variables that determine OXTELLAR XR net sales trajectory?

1) Formulary access and PBM contracting

• Preferred tier placement sustains script volume.
• Contracting terms (rebates and LTV) influence net price more than list price.

2) Generic substitution and multi-source pressure

• When supply expands, net price typically falls faster.
• The speed of switching depends on whether prescribers view alternatives as therapeutically equivalent and on plan-driven substitution.

3) Patient adherence and titration behavior

• ER regimens support adherence in stable patients.
• Breakthrough seizures or tolerability issues can drive discontinuation or switches.

4) Competitive landscape inside antiseizure class

• Antiseizure markets shift prescriptions across brands even if the same molecule category is targeted.
• New entrants and class trends can reallocate share independent of oxcarbazepine-specific economics.

How should investors and business teams model OXTELLAR XR revenue under generic launch and payer scenarios?

A practical model structure for ER antiseizure brands uses:

• baseline script volume and persistence,
• net price ramp down under PBM renegotiations,
• substitution elasticity after generic ER/IR competition, and
• channel mix changes (commercial vs Medicaid/managed care).

Without verified financials and post-launch generic timeline, a scenario table with specific percentages cannot be produced under the constraints.

Key Takeaways

• Oxtellar XR’s market dynamics are payer-driven and heavily influenced by ER vs IR substitution economics within oxcarbazepine and by PBM formulary contracting.
• Its financial trajectory is most sensitive to the timing of exclusivity and patent barrier removal and to generic uptake speed after launch.
• Building a decision-grade revenue outlook requires tying Oxtellar XR strength-specific regulatory status to Orange Book and litigation timelines, then mapping that calendar into net price and prescription conversion assumptions.

FAQs

1. How does payer step therapy typically affect Oxtellar XR utilization in focal seizure patients?
2. What factors determine whether neurologists switch from Oxtellar XR to generic oxcarbazepine ER?
3. How do rebate and net price dynamics usually change after generic oxcarbazepine ER launches?
4. Which antiseizure competitors most often displace branded ER options for focal seizures from formularies?
5. What market indicators best predict revenue erosion risk for branded antiseizure ER products?

References

1. [No sources were provided or retrievable in this environment.]