CARBAMAZEPINE - Generic Drug Details

What are the generic drug sources for carbamazepine and what is the scope of freedom to operate?

Carbamazepine is the generic ingredient in eight branded drugs marketed by Apotex Inc, Nostrum Labs Inc, Taro, Teva Pharms, Takeda Pharms Usa, Validus Pharms, Lundbeck Pharms Llc, Chartwell Rx, Novitium Pharma, Novartis, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Ajanta Pharma Ltd, Amneal Pharms, Anbison Lab, Apotex, Cspc Ouyi, Epic Pharma Llc, Novast Labs, Osmotica Pharm Us, Umedica, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Bionpharma, Inwood Labs, Pliva, Rk Pharma, Unichem, Usl Pharma, and Warner Chilcott, and is included in forty-six NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbamazepine has seventy-eight patent family members in twenty-one countries.

There are twenty-seven drug master file entries for carbamazepine. Forty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for CARBAMAZEPINE

International Patents:	78
US Patents:	8
Tradenames:	8
Applicants:	34
NDAs:	46
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	182
Patent Applications:	6,748
Drug Prices:	Drug price trends for CARBAMAZEPINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CARBAMAZEPINE
What excipients (inactive ingredients) are in CARBAMAZEPINE?	CARBAMAZEPINE excipients list
DailyMed Link:	CARBAMAZEPINE at DailyMed

See drug prices for CARBAMAZEPINE

See drug sales revenues for CARBAMAZEPINE

Recent Clinical Trials for CARBAMAZEPINE

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

Sponsor	Phase
Alexion Pharmaceuticals, Inc.	Phase 1
Arvinas Estrogen Receptor, Inc.	Phase 1
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company	Phase 1

See all CARBAMAZEPINE clinical trials

Generic filers with tentative approvals for CARBAMAZEPINE

Applicant	Application No.	Strength	Dosage Form
		300MG	CAPSULE, EXTENDED RELEASE; ORAL
		200MG	CAPSULE, EXTENDED RELEASE; ORAL
		100MG	CAPSULE, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CARBAMAZEPINE

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

Medical Subject Heading (MeSH) Categories for CARBAMAZEPINE

Analgesics, Non-Narcotic

Anticonvulsants

Antimanic Agents

Cytochrome P-450 CYP3A Inducers

Anatomical Therapeutic Chemical (ATC) Classes for CARBAMAZEPINE

N03AF	Carboxamide derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for CARBAMAZEPINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EQUETRO	Extended-release Capsules	carbamazepine	100 mg	021710	1	2014-05-23
EQUETRO	Extended-release Capsules	carbamazepine	200 mg and 300 mg	021710	1	2007-08-21
CARBATROL	Extended-release Capsules	carbamazepine	100 mg and 200 mg	020712	1	2006-02-02
TEGRETOL-XR	Extended-release Tablets	carbamazepine	100 mg	020234	1	2005-12-30

US Patents and Regulatory Information for CARBAMAZEPINE

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	020712-002	Sep 30, 1997	AB	RX	Yes	Yes
Torrent Pharms	CARBAMAZEPINE	carbamazepine	TABLET;ORAL	077272-004	Dec 7, 2005		RX	No	No
Unique Pharm	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	211623-003	Apr 24, 2020	AB	RX	No	No
Taro	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	078115-003	Mar 31, 2009	AB	RX	No	No
Unique Pharm	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	211623-001	Apr 24, 2020	AB	RX	No	No
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997	AB	RX	Yes	No
Nostrum Labs Inc	CARBAMAZEPINE	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	076697-001	May 20, 2011	AB	RX	No	No

Expired US Patents for CARBAMAZEPINE

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	5,284,662
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-001	Dec 10, 2004	5,912,013
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-003	Dec 10, 2004	6,977,253
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-002	Mar 25, 1996	5,284,662
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-003	Mar 25, 1996	RE34990
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	6,977,253
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997	6,221,392

International Patents for CARBAMAZEPINE

Country	Patent Number	Title	Estimated Expiration
Poland	1928464
China	114053423	磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions)
World Intellectual Property Organization (WIPO)	2013130666
South Korea	101633479
Russian Federation	2615385	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME RELATED APPLICATIONS)
Denmark	1928464
Portugal	1928464

CARBAMAZEPINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carbamazepine

Introduction to Carbamazepine

Carbamazepine is a widely used antiepileptic drug, also employed in the treatment of bipolar disorder, trigeminal neuralgia, and neuropathic pain. Understanding its market dynamics and financial trajectory is crucial for stakeholders in the pharmaceutical industry.

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[3].

Market Segmentation

The carbamazepine market is segmented based on type (tablets, capsules, liquid) and application (epilepsy, bipolar disorder, trigeminal neuralgia, neuropathic pain, alcohol withdrawal). Geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa are also key segments[3][4].

Drivers of Market Growth

Several factors are driving the growth of the carbamazepine market:

• Increasing Incidence of Neurological Conditions: The rising incidence of epilepsy and bipolar disorder globally is a significant driver. Improved diagnostic methods and growing awareness contribute to higher demand for carbamazepine[3].
• Advancements in Medication Formulations: Improvements in drug formulations, such as prolonged-release versions, enhance patient compliance and treatment efficacy, further propelling market growth[3].
• Generic Availability: The availability of generic carbamazepine provides affordable alternatives, expanding the market reach[3].
• Research into Novel Therapeutic Uses: Continuous research into new therapeutic applications and combinations of carbamazepine enhances its utility and market potential[3].

Challenges in Q4 2024

The carbamazepine API market is expected to face significant challenges in Q4 2024:

• 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].
• Economic Uncertainties: Global economic uncertainties, including persistent inflation and constrained healthcare budgets, will compel buyers to adopt conservative purchasing strategies. This will result in reduced volume-based procurement and a shift towards just-in-time inventory models to mitigate financial risks[1].
• Currency Volatility: Depreciating local currencies in key importing regions will erode purchasing power, forcing manufacturers to recalibrate their procurement strategies and contributing to reduced demand and more conservative inventory management approaches[1].

Impact of Economic Factors

Economic factors play a critical role in shaping the carbamazepine market:

• Pricing Pressures: The competitive landscape will allow buyers to negotiate more favorable terms, further pressuring API pricing and market dynamics. Volatile pricing mechanisms will trigger a cautious "wait-and-watch" approach among downstream buyers, contributing to market contraction[1].
• Inventory Management: The strategic shift towards more targeted neurological and psychiatric treatments, coupled with inventory overhang, will dampen carbamazepine API procurement. This will result in a self-reinforcing cycle of reduced demand and price pressures[1].

Regional Variations

Regional variations will significantly influence the market:

• Geographical Segmentation: The market is segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own set of economic, healthcare, and regulatory dynamics that will impact the demand and pricing of carbamazepine[3][4].
• Country-Specific Trends: Country-level trends, including GDP, healthcare budgets, and regulatory environments, will also play a crucial role in shaping the market. For instance, regions with stronger healthcare systems and higher GDP are likely to have more stable demand for carbamazepine[4].

Competitive Landscape

The competitive landscape of the carbamazepine market is characterized by:

• Key Players: Companies like Novartis and Teva are focusing on strategy building to strengthen their product portfolios and expand their business globally. These companies are investing in research and development to enhance the therapeutic uses of carbamazepine[4].
• Market Strategies: Stakeholders are advised to maintain agile strategies, closely monitor regional variations, and remain adaptable to the rapidly transforming pharmaceutical API landscape. This includes leveraging competitive pricing mechanisms and negotiating favorable terms[1].

Economic Appraisal and Cost-Effectiveness

An economic appraisal of carbamazepine highlights its cost-effectiveness:

• 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 the challenges in Q4 2024, 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.
• Innovative Therapeutic Uses: Continuous research into novel therapeutic applications will enhance the market potential of carbamazepine.
• Generic and Branded Options: The availability of both generic and branded carbamazepine will provide a range of options for patients, contributing to market growth[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 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.

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[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[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[3].

Q: How will economic uncertainties impact the carbamazepine API market in Q4 2024? A: Economic uncertainties will lead to demand contraction, pricing pressures, and more conservative inventory management approaches, resulting in reduced demand and price pressures[1].

Q: Which regions are expected to be most lucrative for the carbamazepine market in the near future? A: Regions with strong healthcare systems and higher GDP, such as North America and Europe, are likely to be more lucrative due to stable demand and better economic conditions[4].

Cited Sources

1. ChemAnalyst: Q4-2024 Carbamazepine API Market Forecast - ChemAnalyst.
2. PubMed: An economic appraisal of carbamazepine, lamotrigine, phenytoin ...
3. Market Research Intellect: Carbamazepine Market Size and Projections.
4. Cognitive Market Research: Carbamazepine Market Report 2024 (Global Edition).