TEGRETOL-XR Drug Patent Profile

Which patents cover Tegretol-xr, and when can generic versions of Tegretol-xr launch?

Tegretol-xr is a drug marketed by Novartis and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tegretol-xr

A generic version of TEGRETOL-XR was approved as carbamazepine by TARO on October 3^rd, 1996.

Summary for TEGRETOL-XR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	25
Patent Applications:	3,193
Drug Prices:	Drug price information for TEGRETOL-XR
DailyMed Link:	TEGRETOL-XR at DailyMed

See drug prices for TEGRETOL-XR

See drug sales revenues for TEGRETOL-XR

Recent Clinical Trials for TEGRETOL-XR

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

Sponsor	Phase
Arvinas Estrogen Receptor, Inc.	Phase 1
Pfizer	Phase 1
Dr Cipto Mangunkusumo General Hospital	Phase 4

See all TEGRETOL-XR clinical trials

Pharmacology for TEGRETOL-XR

Drug Class	Mood Stabilizer
Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Paragraph IV (Patent) Challenges for TEGRETOL-XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEGRETOL-XR	Extended-release Tablets	carbamazepine	100 mg	020234	1	2005-12-30

US Patents and Regulatory Information for TEGRETOL-XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-001	Mar 25, 1996	AB	RX	Yes	No
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-002	Mar 25, 1996	AB	RX	Yes	No
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-003	Mar 25, 1996	AB	RX	Yes	Yes

Expired US Patents for TEGRETOL-XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-001	Mar 25, 1996	5,284,662
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-003	Mar 25, 1996	RE34990
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-003	Mar 25, 1996	5,284,662
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-002	Mar 25, 1996	RE34990
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-001	Mar 25, 1996	RE34990

International Patents for TEGRETOL-XR

See the table below for patents covering TEGRETOL-XR around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1302267	PRODUIT THERAPEUTIQUE AYANT UNE ACTION SYSTEMIQUE, ADMINISTRE PAR VOIEBUCCALE (ORAL THERAPEUTIC SYSTEM HAVING SYSTEMIC ACTION)
Japan	S6344525	ORAL THERAPEUTICAL SYSTEM HAVING GENERAL ACTIVITY AND MANUFACTURE
Finland	86143
South Korea	950006219
Austria	A199387

Market Dynamics and Financial Trajectory for TEGRETOL-XR

Last updated: July 27, 2025

Introduction
TEGRETOL-XR (carbamazepine extended-release), a long-acting formulation of the anticonvulsant carbamazepine, has established itself within the niche market of epilepsy and neuropathic pain management. As a successor to traditional immediate-release formulations, TEGRETOL-XR’s market penetration hinges on evolving clinical preferences, regulatory landscapes, and competitive dynamics. This analysis explores the current market forces affecting TEGRETOL-XR and projects its financial trajectory over the coming years.

Market Overview and Positioning
Carbamazepine remains a cornerstone in epilepsy treatment, with TEGRETOL-XR targeting patients requiring sustained therapeutic levels, improved compliance, and reduced dosing frequency. Its extended-release profile allows for once-daily dosing, which enhances adherence—an essential factor given the chronic nature of the target diseases. Globally, the epilepsy drug market was valued at approximately USD 4.5 billion in 2022, with a compound annual growth rate (CAGR) of 4.1% projected through 2030 [1].

In this context, TEGRETOL-XR’s primary markets include North America, Europe, and select Asia-Pacific countries, where robust healthcare infrastructure and increasing epilepsy prevalence support sustained demand. Its main competitors are immediate-release carbamazepine formulations and other extended-release anticonvulsants like oxcarbazepine (Trileptal) and newer agents such as pregabalin and gabapentin.

Market Drivers

• Clinical Advantages and Patient Compliance: The transition to extended-release formulations like TEGRETOL-XR significantly improves patient adherence by reducing dosing frequency. Enhanced compliance reduces seizure episodes and hospitalization risks, thereby stimulating demand.

• Growing Prevalence of Epilepsy: The global epilepsy prevalence is estimated at 50 million individuals, with incidence rising due to demographic aging and increased diagnosis. This demographic trend supports ongoing prescription of carbamazepine and derivatives [2].

• Regulatory Approvals and Guidelines Adoption: Positive clinical data and regulatory approvals in multiple jurisdictions bolster confidence among prescribers. Moreover, guideline endorsements from organizations such as the American Epilepsy Society promote increased utilization.

• Cost-effectiveness and Oral Bioavailability: TEGRETOL-XR's well-established manufacturing infrastructure and competitive pricing favor its uptake, especially in health systems emphasizing cost-effective chronic treatment options.

Market Challenges

• Generic Competition: Post-patent expiration, numerous generic versions of carbamazepine have entered markets. Although TEGRETOL-XR's extended-release formulation enjoys intellectual property protections in certain regions, generic competition exerts downward pressure on prices in others, constraining margins [3].

• Safety and Regulatory Risks: Notable adverse effects related to carbamazepine, including hyponatremia and hematological issues, necessitate vigilant monitoring, which can discourage some prescribers and patients. Regulatory scrutiny remains high, especially regarding safety alerts and post-marketing surveillance.

• Emergence of Newer Therapies: Advances in epilepsy pharmacotherapy, including novel antiepileptic drugs with potentially better side effect profiles and efficacy, threaten market share. Drugs such as cannabidiol (Epidiolex) and lacosamide gain popularity, primarily in refractory epilepsy.

• Pricing Pressures: Governments and payers increasingly emphasize cost containment, which can lead to price negotiations and access restrictions, impacting revenue streams.

Financial Trajectory and Revenue Outlook

The financial trajectory of TEGRETOL-XR depends on multiple interrelated factors:

1. Market Penetration Growth
   Given its clinical benefits, TEGRETOL-XR is poised for moderate growth in existing markets, driven by expanding indications and increased awareness. In North America, the anticonvulsant market expands at roughly 3–4% annually, with TEGRETOL-XR contributing an estimated 1–2% share of that segment [4].

2. Pricing and Revenue Scenarios
   Initial premium pricing for TEGRETOL-XR, suggestive of extended-release technology, was approximately 30–50% higher than immediate-release formulations. Over time, pricing will stabilize due to generic competition, with projected average price erosion of 10–15% annually post-generic entry.

3. Market Share Dynamics
   In mature markets, TEGRETOL-XR’s market share may plateau or decline marginally owing to competitive pressures, yet maintaining at least 10–15% of the carbamazepine prescribed segment through differentiation and physician preference. Emerging markets could exhibit higher growth rates, contingent on regulatory approvals and local healthcare infrastructure.

4. Revenue Projections (2023–2030)
   Assuming a conservative CAGR of 3–4%, driven by continued demand and incremental market expansion, revenues could reach USD 500–600 million globally by 2030. This projection considers declining unit prices, competitive threats, and regulatory hurdles but presumes successful lifecycle management and pipeline expansion (e.g., new formulations or indications).

5. Impact of Patent and Regulatory Landscape
   Patent protections and exclusivity rights are crucial for financial stability. Potential patent expirations, expected in the late 2020s, could precipitate generic competition, compress margins, and necessitate cost optimization strategies.

Strategic Considerations for Sustained Growth

• Pipeline Diversification: Developing combination products or formulations targeting refractory epilepsy or comorbid conditions could unlock new revenue streams.

• Market Expansion: Introducing TEGRETOL-XR into emerging markets with rising epilepsy prevalence and expanding insurance coverage can foster revenue growth.

• Brand Positioning and Education: Concerted efforts to position TEGRETOL-XR as a preferred long-term therapy can sustain prescribing habits even amid competitor innovations.

Conclusion
TEGRETOL-XR’s market dynamics reflect a product embedded within a mature yet growing segment of epilepsy therapy. Its success hinges on balancing clinical advantages with competitive pressures, pricing strategies, and regulatory shifts. While near-term growth remains steady, long-term financial success depends on innovative pipeline development and strategic market expansion.

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Key Takeaways

• TEGRETOL-XR benefits from improved patient compliance and established clinical efficacy, underpinning steady demand in global epilepsy markets.
• Pricing pressures and generic competition will diminish premium margins over time, with revenues dependent on maintaining market share.
• Developing new formulations, expanding into emerging markets, and securing regulatory approvals are critical to extending its financial trajectory.
• Monitoring technological advances and competing therapies is vital for strategic planning, especially amid available alternatives with better safety profiles.
• Proactive lifecycle management, including pipeline innovation and tailored market strategies, will be essential in sustaining revenue growth through 2030.

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FAQs

1. What distinguishes TEGRETOL-XR from other carbamazepine formulations?
TEGRETOL-XR offers an extended-release profile that allows once-daily dosing, improving compliance relative to immediate-release versions. Its sustained plasma levels potentially reduce side effects linked to peak concentrations.

2. When is the patent expiry for TEGRETOL-XR, and how does it impact market access?
Patent protections generally expire in the late 2020s, after which generic versions may enter markets, intensifying price competition and affecting revenue streams.

3. How does TEGRETOL-XR compare economically to newer antiepileptic drugs?
While traditional formulations like TEGRETOL-XR tend to be cost-effective compared to newer drugs, its economic advantage diminishes with generic competition. Newer agents may offer better safety profiles but at higher costs, influencing prescribing choices.

4. Are there emerging indications that could broaden TEGRETOL-XR’s market?
Yes, ongoing research explores its use in bipolar disorder and neuropathic pain, potentially expanding its therapeutic applications and revenue base.

5. What are the main risks facing TEGRETOL-XR’s market growth?
Key risks include patent expiration leading to generic competition, safety concerns, regulatory hurdles, and the emergence of newer, more effective treatments.

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Sources
[1] MarketWatch, "Global Antiepileptic Drugs Market," 2022.
[2] WHO, "Epilepsy Fact Sheet," 2022.
[3] FDA, "Carbamazepine Patent Data," 2021.
[4] IBISWorld, "Pharmaceuticals Market Report," 2022.