CARBATROL Drug Patent Profile

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

Carbatrol is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in CARBATROL 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 Carbatrol

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

Summary for CARBATROL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	163
Patent Applications:	2,957
Drug Prices:	Drug price information for CARBATROL
Drug Sales Revenues:	Drug sales revenues for CARBATROL
What excipients (inactive ingredients) are in CARBATROL?	CARBATROL excipients list
DailyMed Link:	CARBATROL at DailyMed

See drug prices for CARBATROL

See drug sales revenues for CARBATROL

Pharmacology for CARBATROL

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 CARBATROL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CARBATROL	Extended-release Capsules	carbamazepine	100 mg and 200 mg	020712	1	2006-02-02

US Patents and Regulatory Information for CARBATROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-003	Sep 30, 1997	AB	RX	Yes	No
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997	AB	RX	Yes	No
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-002	Sep 30, 1997	AB	RX	Yes	Yes

Expired US Patents for CARBATROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997	6,221,392
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-003	Sep 30, 1997	5,326,570
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-002	Sep 30, 1997	5,912,013
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-002	Sep 30, 1997	5,326,570
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997	5,912,013
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997	5,326,570
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-003	Sep 30, 1997	5,912,013

International Patents for CARBATROL

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9301804
Germany	69230112
Japan	H06511484
Portugal	2147669
Canada	2284663	DISSOLUTION RAPIDE DE FORME POSOLOGIQUE DE BONNE TENUE (RAPIDLY DISSOLVING ROBUST DOSAGE FORM)
Japan	2001524956
European Patent Office	2266538	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)

CARBATROL Market Analysis and Financial Projection Experimental

Carbamazepine Market Dynamics and Financial Trajectory: A Comprehensive Analysis

Introduction to Carbamazepine

Carbamazepine, marketed under various brand names including Carbatrol, is a crucial medication used in the treatment of several neurological and psychiatric conditions. This article delves into the market dynamics and financial trajectory of carbamazepine, highlighting key drivers, challenges, and future prospects.

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[2][3].

Market Segmentation

The carbamazepine market is segmented based on:

• 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][2][3].

Drivers of Market Growth

Several factors are driving the growth of the carbamazepine market:

• Increasing Incidence of Neurological Conditions: The rising prevalence of epilepsy, bipolar disorder, and other neurological conditions is a significant driver. Improved diagnostic methods and growing awareness contribute to increased demand for carbamazepine[1][2][3].
• Advancements in Medication Formulations: Improvements in formulations, such as prolonged-release options, enhance patient compliance and treatment efficacy. For instance, the FDA-approved controlled release formulation of carbamazepine has shown fewer side effects[3].
• Availability of Generic Options: The presence of generic carbamazepine provides affordable alternatives, expanding the market reach[1][2][3].

Economic Factors and Challenges

Economic uncertainties and market dynamics pose several challenges:

• Demand Contraction and Pricing Pressures: Global economic uncertainties, including inflation and constrained healthcare budgets, lead to cautious purchasing strategies and reduced volume-based procurement. This results in demand contraction and pricing pressures[2].
• Inventory Management: Pharmaceutical manufacturers are adopting more conservative inventory management approaches due to saturated market conditions, further impacting demand and pricing[2].
• Currency Volatility: Depreciating local currencies in key importing regions erode purchasing power, forcing manufacturers to recalibrate their procurement strategies[2].

Regional Variations

Regional variations significantly influence the market:

• Key Players and Strategies: Companies like Novartis and Teva are focusing on strategy building to strengthen their product portfolios and expand globally. These companies invest in research and development to enhance the therapeutic uses of carbamazepine[2][3].
• Market Strategies: Stakeholders are advised to maintain agile strategies, closely monitor regional variations, and remain adaptable to the rapidly transforming pharmaceutical API landscape[2].

Cost-Effectiveness and Economic Appraisal

Carbamazepine is highlighted for its cost-effectiveness:

• Cost-Minimization Model: Studies show that carbamazepine is cost-effective compared to other antiepileptic drugs. 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[2][3].
• Innovative Therapeutic Uses: Continuous research into novel therapeutic applications will enhance the market potential of carbamazepine. For example, the FDA approval of Carnexiv for adult patients unable to take oral carbamazepine expands its therapeutic use[3].
• Generic and Branded Options: The availability of both generic and branded carbamazepine provides a range of options for patients, contributing to market growth[2][3].

Competitive Landscape

The market is characterized by a competitive landscape with several key players:

• Leading Companies: Novartis, Teva, Mylan, Sun Pharmaceuticals, and Torrent Pharmaceuticals are among the prominent companies in the carbamazepine market. These companies are profiled based on their product portfolios, financial standing, and recent developments[1][3].

Regulatory Approvals and Side Effects

Regulatory approvals and potential side effects are critical considerations:

• FDA Approvals: The FDA has approved carbamazepine for various conditions, including epilepsy, manic episodes of bipolar disorders, and trigeminal neuralgia. However, there are risks of severe dermatologic reactions and hematologic effects such as agranulocytosis and aplastic anemia[3].

Market Trends and Opportunities

The dynamic growth of related markets presents lucrative opportunities:

• Epilepsy Market: The increasing number of epilepsy cases, especially in the mid-teen age group, presents growth opportunities for carbamazepine. Newer therapies for epilepsy and bipolar depression have seen significant adoption[3].
• Other Conditions: The growing incidence of alcohol withdrawal disorders, central partial diabetes insipidus, and psychotic disorders also drives the demand for carbamazepine[3].

Key Takeaways

• The carbamazepine market is expected 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.

Frequently Asked Questions (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[2][3].

Q: What is the projected growth rate of the carbamazepine market from 2024 to 2031?

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

Q: What are the primary drivers of the carbamazepine market growth?

A: The primary drivers include the increasing incidence of neurological conditions, advancements in medication formulations, and the availability of generic carbamazepine[2][3].

Q: How will economic uncertainties impact the carbamazepine API market in the near future?

A: Economic uncertainties will lead to demand contraction, pricing pressures, and more conservative inventory management approaches, resulting in reduced demand and price pressures[2].

Q: Which regions are expected to be most lucrative for the carbamazepine market?

A: North America is currently the leading consumer of carbamazepine globally, but other regions such as Europe and Asia-Pacific are also expected to be lucrative due to growing demand and advancements in healthcare infrastructure[2][5].

Sources Cited:

1. Market Research Intellect: "Global Carbamazepine Market Size and Projections"[1].
2. Drug Patent Watch: "Generic CARBAMAZEPINE INN entry, drug patent expiration"[2].
3. Biospace: "Carbamazepine Market is expected to expand at a healthy growth rate by 2025"[3].
4. Casetext: "Rule 7 CCR 1101-3 R17 Ex 07 - Rule 17, Exhibit 7"[4].
5. ChemAnalyst: "Carbamazepine Market Size, Share, Growth & Forecast, 2034"[5].