TEGRETOL Drug Patent Profile

When do Tegretol patents expire, and what generic alternatives are available?

Tegretol is a drug marketed by Novartis and is included in four NDAs.

The generic ingredient in TEGRETOL 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

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

Summary for TEGRETOL

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	25
Patent Applications:	2,461
Drug Prices:	Drug price information for TEGRETOL
Drug Sales Revenues:	Drug sales revenues for TEGRETOL
What excipients (inactive ingredients) are in TEGRETOL?	TEGRETOL excipients list
DailyMed Link:	TEGRETOL at DailyMed

See drug prices for TEGRETOL

See drug sales revenues for TEGRETOL

Recent Clinical Trials for TEGRETOL

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 clinical trials

Pharmacology for TEGRETOL

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

US Patents and Regulatory Information for TEGRETOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TEGRETOL	carbamazepine	SUSPENSION;ORAL	018927-001	Dec 18, 1987	AB	RX	Yes	Yes
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-001	Mar 25, 1996	AB	RX	Yes	No
Novartis	TEGRETOL	carbamazepine	TABLET, CHEWABLE;ORAL	018281-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Novartis	TEGRETOL	carbamazepine	TABLET;ORAL	016608-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-003	Mar 25, 1996	AB	RX	Yes	Yes

Expired US Patents for TEGRETOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TEGRETOL	carbamazepine	SUSPENSION;ORAL	018927-001	Dec 18, 1987	4,409,212
Novartis	TEGRETOL	carbamazepine	TABLET;ORAL	016608-001	Approved Prior to Jan 1, 1982	4,409,212
Novartis	TEGRETOL	carbamazepine	TABLET, CHEWABLE;ORAL	018281-001	Approved Prior to Jan 1, 1982	4,409,212

International Patents for TEGRETOL

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

Country	Patent Number	Title	Estimated Expiration
Italy	1147841	PREPARATI FARMACEUTICI PER LA PROFILASSI ED IL TRATTAMENTO DI INSUFFICIENZA DI RENDIMENTO CEREBRALE
Italy	8248224
Australia	8263382
Philippines	17334	METHOD OF PREVENTING AND TREATING CEREBRAL INSUFFICIENCY
Switzerland	649080	5H-DIBENZ(B,F)AZEPIN-5-CARBOXAMIDE ALS MITTEL ZUR PROPHYLAXE UND BEHANDLUNG VON ZEREBRALER LEISTUNGSINSUFFIZIENZ.

TEGRETOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tegretol (Carbamazepine)

Introduction

Tegretol, known generically as carbamazepine, is a widely used anticonvulsant medication with a broad range of therapeutic applications, including the treatment of epilepsy, bipolar disorder, trigeminal neuralgia, neuropathic pain, and alcohol withdrawal. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Market Size and Projections

The global carbamazepine market was valued at USD 713.4 million in 2023 and is projected to reach USD 958.77 million by 2031, growing at a compound annual growth rate (CAGR) of 3.3% from 2024 to 2031[1][2][3].

Market Segmentation

The carbamazepine market is segmented based on several key factors:

• Type: Tablets, capsules, and liquid formulations.
• Application: Epilepsy, bipolar disorder, trigeminal neuralgia, neuropathic pain, and alcohol withdrawal.
• Geography: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][3].

Drivers of Market Growth

Several factors are driving the growth of the carbamazepine market:

• Increasing Incidence of Neurological Conditions: The rising incidence of epilepsy, bipolar disorder, and other neurological conditions globally increases the demand for carbamazepine[1][3].
• Advancements in Medication Formulations: Improvements in formulations, such as extended-release tablets and capsules, enhance patient compliance and treatment efficacy[1].
• Generic Availability: The availability of generic carbamazepine provides affordable alternatives, contributing to market growth[1].
• Continuous Research: Ongoing research into novel therapeutic uses and combinations of carbamazepine expands its market potential[1].

Economic Factors and Market Impact

Economic uncertainties play a significant role in shaping the carbamazepine market:

• Demand Contraction: Economic uncertainties, including persistent inflation and constrained healthcare budgets, may lead to cautious inventory management and reduced demand[1][3].
• Pricing Pressures: The competitive landscape allows buyers to negotiate favorable terms, further pressuring API pricing and market dynamics[1].
• Currency Volatility: Depreciating local currencies in key importing regions can erode purchasing power, forcing manufacturers to adjust their procurement strategies[1].

Regional Variations

Regional variations significantly influence the market:

• Key Players: Companies like Novartis and Teva are focusing on strategy building, product portfolio strengthening, and global expansion. These companies invest in research and development to enhance the therapeutic uses of carbamazepine[1][4].
• Market Strategies: Stakeholders are advised to maintain agile strategies, closely monitor regional variations, and remain adaptable to the rapidly transforming pharmaceutical API landscape[1].

Economic Appraisal and Cost-Effectiveness

Carbamazepine is economically advantageous:

• Cost-Minimization Model: Studies have shown that carbamazepine is cost-effective compared to other antiepileptic drugs like lamotrigine, phenytoin, and valproate. The direct medical costs of 2-year therapy for carbamazepine are relatively lower, making it a preferred option for many patients[2].

Future Prospects

Despite current challenges, the long-term prospects for the carbamazepine market remain positive:

• Growing Demand: The increasing incidence of neurological conditions and advancements in medication formulations will continue to drive demand for carbamazepine[1][3].
• Innovative Therapeutic Uses: Continuous research into novel therapeutic applications will enhance the market potential of carbamazepine[1].
• Generic and Branded Options: The availability of both generic and branded carbamazepine provides a range of options for patients, contributing to market growth[1].

Competitive Landscape

The competitive landscape of the carbamazepine market is characterized by:

• Leading Players: Companies such as Novartis, Teva, Mylan, Sun Pharmaceuticals, and Torrent Pharmaceuticals are key players in the market. These companies are involved in various strategies including new service/product launches, collaborations, company expansions, and acquisitions[1].
• Market Share: The report includes the market share of leading players, helping stakeholders understand the competitive dynamics and strategies used by top companies to maintain their market position[1].

Recent Developments

Recent agreements and partnerships have significant implications for the market:

• Distribution Rights: In August 2021, Yuyu Pharma obtained the exclusive distribution rights for Tegretol, a medication containing carbamazepine, from Novartis Korea[4].

Regional Growth

The Asia-Pacific region is expected to grow at the highest rate during the forecast period due to:

• Government Funding: Increased government funding and support to improve treatment facilities, especially in emerging economies, drive market growth in this region[4].

Key Takeaways

• The 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 Q4 2024.
• 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

What is the current market size of the carbamazepine market?

The global carbamazepine market was valued at USD 713.4 million in 2023[1][2][3].

What is the projected growth rate of the carbamazepine market?

The carbamazepine market is expected to grow at a CAGR of 3.3% from 2024 to 2031[1][2][3].

What are the main drivers of the carbamazepine market growth?

The main drivers include the increasing incidence of neurological conditions, advancements in medication formulations, availability of generic options, and continuous research into novel therapeutic uses[1].

How do economic uncertainties affect the carbamazepine market?

Economic uncertainties lead to demand contraction, pricing pressures, and cautious inventory management, which can impact the market dynamics and growth[1][3].

Which region is expected to grow at the highest rate in the carbamazepine market?

The Asia-Pacific region is expected to grow at the highest rate due to increased government funding and support for improving treatment facilities[4].

Sources

1. Market Research Intellect - Global Carbamazepine Market Report.
2. Drug Patent Watch - Generic CARBAMAZEPINE INN entry.
3. Market Research Intellect - Market Segmentation and Drivers.
4. GlobeNewswire - Epilepsy Treatment Market Report.
5. University of Maryland, Baltimore - Carbamazepine Final Report.