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-five 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:	2
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	25
Patent Applications:	4,270
Drug Prices:	Drug price information for TEGRETOL-XR
Drug Sales Revenues:	Drug sales revenues 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
Pfizer	Phase 1
Arvinas Estrogen Receptor, Inc.	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	020234-003	Mar 25, 1996
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-001	Mar 25, 1996
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-003	Mar 25, 1996
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-002	Mar 25, 1996
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-002	Mar 25, 1996

International Patents for TEGRETOL-XR

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

Country	Patent Number	Title	Estimated Expiration
Finland	86143
Spain	2007100	PROCEDIMIENTO PARA LA OBTENCION DE UN SISTEMA TERAPEUTICO ORAL A BASE DE CARBAMAZEPINA. (Oral therapeutic system having systemic action)
Australia	7661787
Norway	873298
Hungary	T44930

TEGRETOL-XR Market Analysis and Financial Projection Experimental

Carbamazepine Market Dynamics and Financial Trajectory: A Focus on Tegretol-XR

Market Overview

The global carbamazepine market, which includes Tegretol-XR, is a significant segment within the pharmaceutical industry, particularly in the treatment of neurological conditions. Here’s a detailed look at the market dynamics and financial trajectory of this market.

Current Market Size and Projections

As of 2023, the global carbamazepine market was valued at USD 713.4 million. It is projected to grow to USD 958.77 million by 2031, with a compound annual growth rate (CAGR) of 3.3% from 2024 to 2031[1][3][4].

Market Segmentation

The carbamazepine market is segmented based on several key factors:

By Type

• Tablets
• Capsules
• Liquid

By Application

• Epilepsy
• Bipolar Disorder
• Trigeminal Neuralgia
• Neuropathic Pain
• Alcohol Withdrawal

By Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle East and Africa[1][3][4].

Key Players and Competitive Landscape

Major players in the carbamazepine market include Novartis, Teva, Mylan, Sun Pharmaceuticals, and Torrent Pharmaceuticals. Novartis, in particular, is a significant player with its product Tegretol-XR. These companies are focusing on strategy building, product portfolio enhancement, and global expansion through research and development investments[1][3][4].

Economic Factors and Market Growth

Economic Uncertainties

Global economic uncertainties, including persistent inflation and constrained healthcare budgets, are expected to impact the market. Buyers are likely to adopt conservative purchasing strategies, leading to reduced volume-based procurement and a shift towards just-in-time inventory models to mitigate financial risks[1][3].

Currency Volatility

Depreciating local currencies in key importing regions will erode purchasing power, forcing manufacturers to recalibrate their procurement strategies. This will contribute to reduced demand and more conservative inventory management approaches[1].

Demand Contraction

Pharmaceutical manufacturers are likely to exhibit caution in inventory management due to saturated market conditions, leading to a contraction in demand and pricing pressures[1].

Cost-Effectiveness and Economic Appraisal

Carbamazepine, including Tegretol-XR, is cost-effective compared to other antiepileptic drugs. Studies have shown that the direct medical costs of 2-year therapy for carbamazepine are relatively lower, making it a preferred option for many patients[2][3].

Therapeutic Uses and Market Drivers

Extended-Release Formulations

Extended-release formulations like Tegretol-XR offer the convenience of less-frequent administration and smaller peak-to-trough serum carbamazepine fluctuations. This can improve patient compliance and reduce the risk of adverse events[2].

Increasing Incidence of Neurological Conditions

The growing incidence of neurological conditions such as epilepsy, bipolar disorder, and trigeminal neuralgia is driving the demand for carbamazepine. Continuous research into novel therapeutic applications will further enhance the market potential[1][3][4].

Regional Market Dynamics

The market dynamics vary significantly across different geographical regions:

North America and Europe

These regions are expected to remain significant markets due to their well-established healthcare systems and high demand for neurological treatments.

Asia-Pacific

This region is anticipated to grow rapidly due to increasing healthcare expenditure and a rising incidence of neurological disorders[1][3][4].

Future Prospects

Despite the challenges posed by economic uncertainties and demand contraction, the long-term prospects for the carbamazepine market, including Tegretol-XR, remain positive. Here are some key points:

Growing Demand

The increasing incidence of neurological conditions and advancements in medication formulations will continue to drive demand for carbamazepine[1][3][4].

Innovative Therapeutic Uses

Continuous research into novel therapeutic applications will enhance the market potential of carbamazepine. This includes exploring its use in conditions beyond epilepsy and trigeminal neuralgia[3].

Generic and Branded Options

The availability of both generic and branded carbamazepine will provide a range of options for patients, contributing to market growth. Tegretol-XR, as a branded option, will continue to compete with generic formulations based on its efficacy and patient compliance benefits[1][3][4].

Adverse Events and Safety Profile

Tegretol-XR, like other carbamazepine formulations, carries risks such as aplastic anemia and agranulocytosis, although these are rare. Patients should be closely monitored, and any skin reactions or hematologic changes should be immediately reported to healthcare providers[5].

Market Strategies

To navigate the complexities of the carbamazepine market, stakeholders are advised to:

Maintain Agile Strategies

Closely monitor regional variations and remain adaptable to the rapidly transforming pharmaceutical API landscape[1].

Competitive Pricing

Leverage competitive pricing mechanisms and negotiate favorable terms to maintain market share[1].

Regional Expansion

Develop regional expansion strategies based on the analysis of market dynamics in various locations[1].

"Understanding the market dynamics in various locations and developing regional expansion strategies are both aided by this analysis."[1]

Key Takeaways

• The global carbamazepine market is projected to grow from USD 713.4 million in 2023 to USD 958.77 million by 2031.
• Economic uncertainties and demand contraction are expected to impact the market in the short term.
• Regional variations and competitive strategies will play a crucial role in shaping the market.
• Carbamazepine remains a cost-effective option for treating neurological conditions.
• Continuous research and advancements in medication formulations will drive long-term market growth.

FAQs

Q: What is the current market size of the carbamazepine market?

A: The global carbamazepine market was valued at USD 713.4 million in 2023[1][3][4].

Q: What is the projected growth rate of the carbamazepine market?

A: The market is expected to grow at a CAGR of 3.3% from 2024 to 2031[1][3][4].

Q: What are the key applications of carbamazepine?

A: The key applications include epilepsy, bipolar disorder, trigeminal neuralgia, neuropathic pain, and alcohol withdrawal[1][3][4].

Q: Which companies are major players in the carbamazepine market?

A: Major players include Novartis, Teva, Mylan, Sun Pharmaceuticals, and Torrent Pharmaceuticals[1][3][4].

Q: What are the advantages of extended-release formulations like Tegretol-XR?

A: Extended-release formulations offer the convenience of less-frequent administration and smaller peak-to-trough serum carbamazepine fluctuations, improving patient compliance and reducing adverse events[2].

Sources

1. Market Research Intellect, "Carbamazepine Market Size and Projections".
2. PubMed, "A pharmacoeconomic analysis of the available carbamazepine formulations".
3. Drug Patent Watch, "Generic CARBAMAZEPINE INN entry, drug patent expiration".
4. OpenPR, "Carbamazepine Market: Size, Share, Growth, Analysis, Key Players, Revenue, Growth".
5. Novartis, "Tegretol® Tegretol®-XR Rx only Prescribing Information".