GABITRIL Drug Patent Profile

Which patents cover Gabitril, and what generic alternatives are available?

Gabitril is a drug marketed by Cephalon and is included in one NDA.

The generic ingredient in GABITRIL is tiagabine hydrochloride. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gabitril

A generic version of GABITRIL was approved as tiagabine hydrochloride by MSN on November 16^th, 2021.

Summary for GABITRIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	10
Patent Applications:	5,925
Drug Prices:	Drug price information for GABITRIL
What excipients (inactive ingredients) are in GABITRIL?	GABITRIL excipients list
DailyMed Link:	GABITRIL at DailyMed

See drug prices for GABITRIL

Recent Clinical Trials for GABITRIL

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 2
Rajesh Narendran	Phase 1
Cephalon	Phase 3

See all GABITRIL clinical trials

Paragraph IV (Patent) Challenges for GABITRIL

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 GABITRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999	AB	RX	Yes	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	AB	RX	Yes	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-007	Nov 29, 2005		DISCN	No	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997		DISCN	No	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-001	Sep 30, 1997	AB	RX	Yes	Yes
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-006	Nov 29, 2005		DISCN	No	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	AB	RX	Yes	No

Expired US Patents for GABITRIL

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
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-001	Sep 30, 1997
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997

International Patents for GABITRIL

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

Country	Patent Number	Title	Estimated Expiration
Canada	2220019	COMPOSITION PHARMACEUTIQUE CONTENANT DE L'HYDROCHLORURE DE TIAGABINE ET PROCEDE DE PREPARATION (PHARMACEUTICAL COMPOSITION CONTAINING TIAGABINE HYDROCHLORIDE AND THE PROCESS FOR ITS PREPARATION)
Australia	5644196
Portugal	906309
South Korea	20000016580
Spain	556659
South Africa	9202297
Finland	870810

Supplementary Protection Certificates for GABITRIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0236342	SPC/GB98/022	United Kingdom		PRODUCT NAME: TIAGABINE ( INCLUDING SALTS THEREOF ); REGISTERED: FR AMM NO. 341 260.2 19960614; FR AMM NO. 341 262.5 19960614; FR AMM NO. 341 264.8 19960614; UK 03132/0117 19971111; UK 03132/0118 19971111; UK 03132/0119 19971111
0236342	97C0107	Belgium		PRODUCT NAME: TIAGABINE CHLORHYDRATE MONOHYDRATE - TIAGABINE ANHYDRE; NAT. REGISTRATION NO/DATE: 403 IS 102 F 3 19970602; FIRST REGISTRATION: FR 341 260.2 19960614

Market Dynamics and Financial Trajectory for GABITRIL (Tiagabine)

Last updated: July 29, 2025

Introduction

GABITRIL, the brand name for Tiagabine, is an antiepileptic drug initially approved by the FDA in 1997 for adjunctive treatment of partial seizures. Over the past two decades, its market positioning, competitive landscape, and financial trajectory have undergone significant transitions driven by regulatory decisions, clinical development, and shifting market needs. This report analyzes the intricate market dynamics surrounding GABITRIL, evaluates its current financial outlook, and highlights future growth prospects within the broader epilepsy and neurological therapeutics sector.

Market Overview and Therapeutic Context

Tiagabine operates as a selective GABA reuptake inhibitor, enhancing synaptic GABA concentrations, thereby exerting anticonvulsant effects. The global epilepsy therapeutics market, valued at approximately $5.1 billion in 2022, is projected to expand at a compound annual growth rate (CAGR) of 4.8% through 2030 [1]. The demand for effective, well-tolerated anticonvulsants like GABITRIL is driven by rising epilepsy prevalence, increasing awareness, and advances in personalized medicine.

While first-generation drugs like carbamazepine and phenytoin remain mainstays, newer agents such as levetiracetam have gained ground, further intensifying competition. Tiagabine's niche resides in specific patient subsets, notably those with partial seizures resistant to other therapies, though its market share has been impacted by emerging formulations and newer AEDs.

Regulatory and Market Dynamics

Regulatory Landscape

Initially, GABITRIL's approval catalyzed its adoption in epilepsy management. However, subsequent regulatory decisions have impacted its market. Notably:

• Market Withdrawal in Certain Regions: In 2017, the European Medicines Agency (EMA) withdrew GABITRIL’s marketing authorization for epilepsy due to lack of sufficient clinical benefit over alternative therapies and concerns over neuropsychiatric adverse events [2].

• FDA Status and Market Exclusivity: The FDA continues its approval of GABITRIL in the United States for adjunctive therapy, with no recent patent expirations or exclusivity extensions reported. Patent protection reportedly expired in 2013, leading to an increased presence of generics.

Competitive Market Dynamics

GABITRIL's market share has contracted owing to:

• Generic Competition: Post-patent expiry, the entry of generic tiagabine products has exerted downward pressure on prices, reducing pharmaceutical revenues [3].

• Emerging Therapeutics: Several newer AEDs, including lacosamide and cannabidiol derivatives, have demonstrated improved safety profiles and broader indications, further challenging GABITRIL's market position.

• Side Effect Profile: Concerns over neuropsychiatric adverse effects—such as depression, confusion, and dizziness—have curtailed GABITRIL's use, especially in vulnerable populations, limiting its growth potential [4].

Market Trends and Usage Patterns

Despite these challenges, GABITRIL maintains a niche following in specific demographics:

• Refractory Partial Seizures: Prescribers may consider GABITRIL in cases where patients respond favorably, especially when other agents cause intolerable side effects.

• Off-Label Use: Limited off-label utilization in conditions like anxiety disorders has been reported but remains unsubstantiated by regulatory agencies.

• Pediatric and Geriatric Populations: Market penetration diminishes further due to safety concerns and complex dosing considerations.

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

GABITRIL's revenues peaked shortly after approval in the late 1990s and early 2000s, reaching an estimated $300 million annually worldwide. As patents expired and generics gained market share, revenues declined sharply, averaging around $50–$70 million between 2015 and 2022 [5].

Current Revenue Streams

• United States: The US remains the primary revenue source, with annual sales approximating $30 million, primarily through branded sales and certain curative-specific formulations.

• International Markets: Europe and Asia represent minor segments owing to market withdrawal and limited marketing authorization.

Future Revenue Projections

Given current market dynamics:

• Patent expiration and generic competition predict continued revenue erosion unless new formulations or indications are developed.

• Pipeline Developments: There are no significant ongoing clinical trials or reformulations targeting GABITRIL, limiting prospects for revenue revitalization.

• Market Repositioning: Companies may explore off-label use, combination therapies, or derivative compounds; however, regulatory hurdles and safety profiles pose challenges.

Valuation and Investment Outlook

From an investment perspective, GABITRIL's declining revenue trajectory diminishes its attractiveness within portfolios emphasizing growth drugs. Nonetheless, niche market applications and potential repositioning strategies could sustain minimal revenues for select manufacturers.

Strategic and Commercial Considerations

• Market Differentiation: To secure ongoing revenue, companies may focus on novel delivery systems (e.g., extended-release formulations), or seek new indications.

• Regulatory Re-engagement: Reconsideration of approval status in regions where market withdrawal occurred could be pursued with additional clinical data.

• Cost Optimization: As profits diminish, companies may seek to optimize manufacturing and distribution costs associated with generic versions.

• Pipeline Focus: Pharmaceutical firms are increasingly investing in genetically tailored epilepsy treatments, moving away from older drugs like GABITRIL.

Key Challenges and Opportunities

Challenges:

• Declining market share due to generics and competition.

• Regulatory restrictions impacting geographic availability.

• Safety concerns leading to reduced prescriber confidence.

Opportunities:

• Development of combination therapies incorporating GABITRIL.

• Repositioning for novel indications.

• Identification of underserved patient populations who tolerate GABITRIL better.

Conclusion

The market dynamics surrounding GABITRIL reflect broader trends impacting legacy neurological drugs: patent expiry, generics proliferation, and stiff competition from newer therapies. While its financial trajectory has significantly declined since its peak, niche applications and strategic repositioning could sustain marginal revenues. However, without substantial innovation or new indications, GABITRIL is unlikely to recover its erstwhile market prominence.

---

Key Takeaways

• GABITRIL (Tiagabine) peaked in revenue during the late 1990s but has experienced substantial decline due to patent expiry, generic competition, and safety concerns.

• Regulatory actions, including EMA withdrawal in Europe, have constrained its global market penetration.

• The current global revenue generation is modest, primarily driven by the U.S. market, with projections indicating continued decline absent innovation.

• Strategic opportunities exist in combination therapies and exploring new indications, but significant development efforts are necessary to revitalize its market presence.

• Industry stakeholders should prioritize innovation and regulatory engagement to manage the obsolescence of legacy drugs like GABITRIL effectively.

---

FAQs

1. Why was GABITRIL withdrawn from the European market?
The EMA withdrew GABITRIL in Europe in 2017 due to insufficient evidence of benefit over existing therapies and safety concerns related to neuropsychiatric adverse events.

2. What factors have contributed to the decline in GABITRIL’s sales?
Patent expiration, the entry of cheaper generics, competition from newer AEDs with better safety profiles, and concerns over adverse effects have driven sales decline.

3. Are there ongoing efforts to reintroduce GABITRIL in new indications?
Currently, no significant clinical trials or regulatory efforts are underway to reposition GABITRIL for other indications.

4. How does generic competition impact GABITRIL’s financial outlook?
Generic competition significantly reduces brand-name drug revenues and limits profit margins, making continued investment less attractive.

5. What strategic options exist for companies holding GABITRIL assets?
Options include developing new formulations, exploring off-label indications, establishing combination therapies, or licensing the drug for markets with less competition and regulatory hurdles.

---

Sources:

[1] MarketsandMarkets. "Epilepsy Drugs Market by Type, Distribution Channel, and Region" (2022).
[2] European Medicines Agency. "EMA withdraws marketing authorisation for Tiagabine" (2017).
[3] IQVIA. "Pharmaceutical Market Data," 2022.
[4] U.S. Food and Drug Administration. "GABITRIL (Tiagabine) Highlights of Prescribing Information."
[5] EvaluatePharma. "Global Revenue Trends for Epilepsy Drugs," 2022.