Tiagabine hydrochloride - Generic Drug Details

What are the generic sources for tiagabine hydrochloride and what is the scope of patent protection?

Tiagabine hydrochloride is the generic ingredient in two branded drugs marketed by Cephalon, Amneal Pharms Co, MSN, Sun Pharm Inds, and Wilshire Pharms Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for tiagabine hydrochloride. Five suppliers are listed for this compound.

Summary for tiagabine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	20
Patent Applications:	1,323
What excipients (inactive ingredients) are in tiagabine hydrochloride?	tiagabine hydrochloride excipients list
DailyMed Link:	tiagabine hydrochloride at DailyMed

Recent Clinical Trials for tiagabine hydrochloride

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

Sponsor	Phase
Assiut University	Phase 4
Eisai Inc.	Phase 4
Mid-Atlantic Epilepsy and Sleep Center, LLC	Phase 4

See all tiagabine hydrochloride clinical trials

Pharmacology for tiagabine hydrochloride

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for tiagabine hydrochloride

N03AG	Fatty acid derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TIAGABINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GABITRIL	Tablets	tiagabine hydrochloride	12 mg and 16 mg	020646	1	2014-01-24
GABITRIL	Tablets	tiagabine hydrochloride	2 mg and 4 mg	020646	1	2005-02-01

US Patents and Regulatory Information for tiagabine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msn	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	214816-003	Nov 16, 2021	AB	RX	No	No
Msn	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	214816-002	Nov 16, 2021	AB	RX	No	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-007	Nov 29, 2005		DISCN	No	No

Expired US Patents for tiagabine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997

Tiagabine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tiagabine Hydrochloride

Introduction

Tiagabine hydrochloride, marketed under the brand name Gabitril, is an antiepileptic drug used to treat partial seizures in adults and children aged 12 and older. Understanding the market dynamics and financial trajectory of this drug is crucial for stakeholders, including investors, pharmaceutical companies, and healthcare providers.

Market Size and Growth

The global tiagabine HCl market has been experiencing steady growth, driven by increasing demand for effective antiepileptic medications. As of 2023, the global tiagabine HCl market size was significant, and it is expected to grow at a compound annual growth rate (CAGR) from 2024 to 2031[1].

Key Market Drivers

Several factors drive the growth of the tiagabine HCl market:

Increasing Prevalence of Epilepsy

The rising prevalence of epilepsy globally increases the demand for antiepileptic drugs like tiagabine HCl. This trend is expected to continue, fueling market growth.

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in developing countries, enhance access to advanced medications, including tiagabine HCl.

Regulatory Approvals and Compliance

Regulatory approvals and compliance with international standards ensure the drug's safety and efficacy, boosting market confidence.

Market Restraints

Despite the growth drivers, there are several restraints that affect the market:

Competition from Alternative Treatments

The antiepileptic drug market is highly competitive, with numerous alternative treatments available. This competition can limit the market share of tiagabine HCl.

Side Effects and Safety Concerns

Tiagabine HCl, like other antiepileptic drugs, has potential side effects and safety concerns, such as serious rash and ophthalmologic effects, which can impact its adoption[4][5].

Economic Factors

Economic fluctuations and healthcare budget constraints can influence the affordability and accessibility of tiagabine HCl.

Financial Performance

Historical Context

To understand the financial trajectory of tiagabine HCl, it is helpful to look at the historical performance of companies that have marketed this drug. For example, Cephalon, the company that initially developed and marketed Gabitril, achieved significant financial milestones. In 2001, Cephalon reported product sales of $226 million, with Gabitril being one of its key products contributing to this revenue[2].

Current and Future Projections

The current market size and growth projections indicate a positive financial trajectory for tiagabine HCl. The drug's inclusion in treatment protocols for partial seizures ensures a steady revenue stream. However, the financial performance can be influenced by factors such as pricing strategies, market competition, and regulatory changes.

Regional Analysis

The global tiagabine HCl market is segmented by region, with different regions exhibiting varying growth rates:

North America and Europe

These regions are expected to dominate the market due to well-established healthcare systems and higher adoption rates of advanced medications.

Asia-Pacific and Latin America

These regions are anticipated to show significant growth due to improving healthcare infrastructure and increasing awareness about epilepsy treatment.

Segment Analysis

The market can be segmented by type, dosage form, and end-user:

By Type

Tiagabine HCl is available in various dosage forms, including tablets of 2 mg, 4 mg, 12 mg, and 16 mg. The tablet form accounts for the largest share of the market due to its ease of administration and patient compliance[5].

By End-User

The primary end-users are hospitals, clinics, and pharmacies. The demand from these sectors is driven by the need for effective antiepileptic treatments.

Competitive Analysis

The tiagabine HCl market is competitive, with several pharmaceutical companies involved in its production and distribution. Key players focus on strategic acquisitions, research and development, and marketing efforts to maintain market share.

Technological Trends

Advancements in drug delivery systems and the development of controlled-release formulations can enhance the efficacy and patient compliance of tiagabine HCl. For instance, a controlled-release formulation could offset the clinical disadvantage of the drug's short elimination half-life[3].

Regulatory Environment

Regulatory approvals and compliance are critical for the tiagabine HCl market. The FDA's oversight and guidelines ensure the drug's safety and efficacy, which is essential for maintaining market confidence[4].

Consumer Behavior Analysis

Consumer behavior plays a significant role in the adoption of tiagabine HCl. Patients and caregivers seek medications with proven efficacy and minimal side effects. The drug's safety profile and clinical success in treating partial seizures influence consumer preferences.

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the tiagabine HCl market. While there were disruptions in supply chains and healthcare services, the pandemic also highlighted the importance of maintaining access to essential medications, including antiepileptic drugs.

SWOT Analysis

Strengths

• Proven efficacy in treating partial seizures
• Strong regulatory approvals
• Established market presence

Weaknesses

• Potential side effects and safety concerns
• High competition in the antiepileptic drug market
• Economic constraints affecting affordability

Opportunities

• Growing demand for antiepileptic medications
• Advancements in drug delivery systems
• Expanding into new markets

Threats

• Regulatory changes
• Economic downturns
• Emergence of new competitors

Key Takeaways

• The tiagabine HCl market is expected to grow at a significant CAGR from 2024 to 2031.
• The drug's efficacy in treating partial seizures and its strong regulatory approvals are key drivers.
• Competition, side effects, and economic factors are significant restraints.
• Regional and segment analysis highlights the dominance of North America and Europe, and the tablet form, respectively.
• Technological advancements and regulatory compliance are crucial for market growth.

FAQs

What is tiagabine hydrochloride used for?

Tiagabine hydrochloride, marketed as Gabitril, is used to treat partial seizures in adults and children aged 12 and older.

What are the potential side effects of tiagabine hydrochloride?

Potential side effects include serious rash, ophthalmologic effects, and other adverse reactions associated with antiepileptic drugs.

How does tiagabine hydrochloride work?

Tiagabine hydrochloride inhibits the uptake of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) into astrocytes and neurons, increasing its extracellular concentration and thereby reducing seizure activity[3].

What is the expected market growth for tiagabine HCl?

The global tiagabine HCl market is expected to grow at a significant CAGR from 2024 to 2031, driven by increasing demand and advancements in healthcare infrastructure[1].

Which regions dominate the tiagabine HCl market?

North America and Europe are expected to dominate the market due to their well-established healthcare systems and higher adoption rates of advanced medications.

Sources

1. Global Tiagabine HCl Market Report 2024 Edition - Cognitivemarketresearch.com
2. 2001 Annual Report - Cephalon
3. Tiagabine pharmacology in profile - PubMed
4. Tiagabine hydrochloride (marketed as Gabitril) Information - FDA
5. Gabitril (tiagabine hydrochloride) tablets label - FDA