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. Four 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:	4
Raw Ingredient (Bulk) Api Vendors:	78
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
Mid-Atlantic Epilepsy and Sleep Center, LLC	Phase 4
Eisai Inc.	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	214816-001	Nov 16, 2021	AB	RX	No	No
Msn	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	214816-003	Nov 16, 2021	AB	RX	No	No
Amneal Pharms Co	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	208181-003	Dec 8, 2017		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	5,354,760
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997	5,010,090
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	5,354,760

Market Dynamics and Financial Trajectory for Tiagabine Hydrochloride

Last updated: July 28, 2025

Introduction

Tiagabine hydrochloride stands as a notable antiepileptic drug, primarily prescribed for the management of partial seizures. Since its introduction, its market performance reflects nuanced dynamics shaped by evolving clinical practices, competitive landscape, regulatory considerations, and broader healthcare trends. This analysis explores the current market environment, growth prospects, and financial trajectory of tiagabine hydrochloride, essential for stakeholders aiming to navigate this sector effectively.

Pharmacological Profile and Clinical Applications

Tiagabine is a gamma-aminobutyric acid (GABA) reuptake inhibitor that enhances GABAergic activity, offering symptomatic seizure control. Initially approved by the U.S. Food and Drug Administration (FDA) in 1997, its pivotal use is in adjunctive therapy for partial-onset seizures in adults [1]. The drug’s mechanism offers a targeted approach, appealing to clinicians seeking alternatives amid rising multidisciplinary management strategies for epilepsy.

However, the drug’s clinical adoption has been influenced by its safety profile and competitive positioning. Adverse effects such as dizziness, fatigue, and psychiatric disturbances have posed challenges, impacting prescribing patterns [2].

Market Landscape and Competitive Dynamics

Market Penetration and Prescribing Trends

In the U.S., tiagabine was once a prominent player among second-generation antiepileptics, but its market share has significantly diminished. The proliferation of newer agents, such as levetiracetam, lamotrigine, and lacosamide, offers broader efficacy and improved safety profiles, leading to decreased reliance on tiagabine [3].

Global markets, particularly in Europe and emerging economies, reflect similar dynamics. While some countries continue to prescribe tiagabine, overall utilization trends indicate a gradual decline, consistent with clinical guideline updates favoring newer drugs.

Patent Status and Market Exclusivity

Tiagabine’s patent protection expired in multiple jurisdictions around the late 2010s, culminating in generic formulations entering the market. Generics significantly reduce drug prices, eroding profit margins for pharmaceutical companies and diminishing revenue potential. The availability of cheaper alternatives further constrains market growth.

Regulatory and Safety Considerations

Regulatory agencies have monitored the safety signals associated with tiagabine, especially neurobehavioral adverse effects. Although no sweeping bans occurred, these issues have prompted cautious prescribing, limiting market expansion, particularly in vulnerable populations.

Market Drivers and Restraints

Drivers

• Unmet Clinical Needs: Persistent cases where newer agents are unsuitable for particular patients—such as those with comorbidities—maintain niche usage.
• Off-Label and Investigational Uses: Exploratory research into tiagabine’s potential for other neuropsychiatric conditions, such as anxiety disorders, might open additional avenues.
• Regional Expansion: In emerging markets with limited access to newer medications, tiagabine remains relevant due to cost considerations.

Restraints

• Market Saturation: In developed markets, the dominance of newer antiepileptics reduces tiagabine’s market share.
• Safety and Tolerability Profile: Concerns over adverse effects hinder broader acceptance.
• Availability of Alternatives: Multiple effective, safer, and often more convenient-to-use agents challenge tiagabine’s market position.

Financial Trajectory and Revenue Forecast

Historical Financial Performance

Since its initial launch, tiagabine experienced rapid growth, becoming a key product for its initial manufacturers. However, post-generic entry and competition, revenues declined sharply. In 2013, Pfizer—then the sole authorized manufacturer—licensed out rights to other firms as patent protections waned, leading to a fragmented market landscape and declining sales figures [4].

Projected Market Trends

• Declining Revenue: With lack of patent protection and high competition, revenues are projected to diminish steadily over the next five years.
• Generic Market Share Dominance: Generics are set to dominate sales, with major players focusing on cost-efficient production.
• Limited Upside: Clinical trials exploring off-label use or new indications are unlikely to produce significant revenue streams for tiagabine due to safety concerns and market preferences.

Impact of Regulatory Changes and Market Entry

Regulatory hurdles in certain jurisdictions and the introduction of biosimilar/generic versions further suppress prices. Large pharmaceutical firms aiming for exclusivity or market leadership have shifted focus to pipeline compounds rather than tiagabine.

Potential for Niche Growth

Despite the overall decline, niche segments—such as treatment-resistant epilepsy cases—may sustain minimal revenues. Additionally, regional markets with limited access to newer agents could provide modest growth opportunities, but these are constrained by competition from other generics and local affordability factors.

Strategic Implications

Pharmaceutical companies considering tiagabine-related assets should anticipate a contracting market with limited growth prospects. Investment strategies should prioritize developing new formulations, exploring adjunct or combination therapies, or pivoting to novel therapeutic candidates with higher market potential.

Key Market Opportunities and Challenges

Opportunities	Challenges
Niche market segments in underdeveloped regions	Shrinking overall market due to obsolescence and competition
Off-label research into neuropsychiatric indications	Safety profile risks limiting wider use
Cost-sensitive markets favoring generics	Price erosion and patent expirations

Conclusion

Tiagabine hydrochloride's market landscape is characterized by a transitioning paradigm. While early years indicated promising growth, the advent of newer, safer, and more effective agents has led to a significant decline in its market presence. Revenue streams are expected to continue diminishing, with niche applications and regional markets providing minor offsets. Stakeholders should reassess their portfolios, considering the limited scope for future expansion and focusing on innovation or value-added therapies within the neuropharmacological sector.

Key Takeaways

• Market Decline: Tiagabine's global revenues have contracted significantly post-patent expiry due to competition from newer antiepileptic agents.
• Competitive Pressures: The presence of multiple alternatives with improved safety and tolerability has reduced its clinical and commercial appeal.
• Limited Growth Prospects: The drug's future revenue potential is confined to niche markets, with minimal opportunities for expansion.
• Strategic Focus: Companies should consider repositioning, developing derivatives, or exploring new therapeutic indications rather than investing in tiagabine non-core markets.
• Regulatory and Safety Factors: Ongoing vigilance over safety profiles influences prescribing trends and market viability.

FAQs

1. Why has the market for tiagabine hydrochloride declined over the years?
The decline results from patent expiry leading to generic competition, the introduction of newer antiepileptics with better safety profiles, and shifting prescribing standards favoring agents like levetiracetam and lamotrigine.

2. Are there ongoing clinical trials exploring new uses for tiagabine?
Limited trials have investigated tiagabine for off-label uses such as anxiety or mood disorders, but safety concerns and market preference for newer therapies have limited its development trajectory.

3. How does patent expiration impact tiagabine’s market revenue?
Patent expiry enables generic manufacturers to enter the market, drastically reducing drug prices and eroding exclusivity-driven revenues for brand-name producers.

4. What are the main regulatory concerns surrounding tiagabine?
Regulatory agencies have monitored neuropsychiatric adverse effects, including psychiatric disturbances and suicidality risk, which influence prescribing practices and market acceptance.

5. Is tiagabine still relevant in the current epilepsy treatment landscape?
While still prescribed in certain niche contexts, its overall relevance has diminished, supplanted by newer, more tolerable antiepileptic drugs with broader approval and better safety profiles.

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References

[1] U.S. Food and Drug Administration. (1997). Tiagabine Hydrochloride New Drug Application.
[2] Epilepsy Foundation. (2020). Tiagabine Overview.
[3] MarketWatch. (2021). The Global Antiepileptic Drugs Market and Competitive Analysis.
[4] Pharmaceutical Business Review. (2013). Tiagabine Patent Expiration and Market Impact.