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 SUN PHARM INDS on November 4^th, 2011.

Summary for GABITRIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	144
Clinical Trials:	10
Patent Applications:	4,904
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	020646-001	Sep 30, 1997	AB	RX	Yes	Yes
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	AB	RX	Yes	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997		DISCN	No	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999	AB	RX	Yes	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-007	Nov 29, 2005		DISCN	No	No

Expired US Patents for GABITRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	5,958,951
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	5,958,951
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999	5,010,090
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	5,354,760
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	5,010,090

International Patents for GABITRIL

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

Country	Patent Number	Title	Estimated Expiration
Argentina	008236	FORMA CRISTALINA ANHIDRA DEL CLORHIDRATO DE ACIDO R(-)-N-(4,4-DI(3- METILTIEN-2-IL)BUT-3-ENIL)-NIPECOTICO, UNA COMPOSICION FARMACEUTICA Y EL USO DE DICHA SAL CRISTALINA PARA LA PREPARACION DE UNA COMPOSICION FARMACEUTICA
Austria	223405
Israel	118142
Norway	870781
South Korea	100440354

Supplementary Protection Certificates for GABITRIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for GABITRIL (Tiagabine Hydrochloride)

Introduction

GABITRIL, known generically as tiagabine hydrochloride, is an antiepilepsy drug used to treat certain types of seizures. Understanding its market dynamics and financial trajectory is crucial for investors, pharmaceutical companies, and healthcare professionals.

Approval and Availability

GABITRIL was approved by the FDA on September 30, 1997, and is available in various strengths, including 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration[1][4].

Generic Availability

The generic version of GABITRIL, tiagabine hydrochloride, has been approved and is available in the market. Companies like Amneal Pharmaceuticals have launched generic equivalents, which are AB-rated therapeutic equivalents to GABITRIL[3][4].

Market Impact of Generic Entry

The introduction of generic versions of GABITRIL has significantly impacted its market dynamics. Generic drugs typically reduce the market share and revenue of the branded version due to their lower prices. As of 2018, the annual U.S. sales of GABITRIL and its generic equivalents were approximately $30 million, indicating a decline in revenue for the branded product[3].

Clinical Efficacy and Market Position

GABITRIL has demonstrated efficacy in reducing seizure rates in clinical trials. Studies have shown that it provides a statistically significant reduction in partial and complex partial seizure rates compared to placebo. This efficacy supports its continued use in the market, despite the presence of generics[1].

Financial Performance

Revenue Trends

The revenue from GABITRIL has declined since the introduction of generic versions. The market data from 2018 indicated that the annual U.S. sales were $30 million, which is a significant drop from the pre-generic era. This decline is typical for branded drugs facing generic competition[3].

Pharmaceutical Company Financials

Pharmaceutical companies that once held the exclusive rights to GABITRIL, such as Cephalon (now part of Teva Pharmaceutical Industries), have seen a reduction in revenue from this product. This reduction is part of a broader trend where branded drugs lose market share and revenue once generics enter the market.

Competitive Landscape

The antiepilepsy drug market is highly competitive, with several other drugs available for treating various types of seizures. The entry of generics for GABITRIL has increased competition, making it challenging for the branded version to maintain its market share.

Pricing Dynamics

The pricing of GABITRIL has been affected by the availability of generic alternatives. Generic tiagabine hydrochloride is generally priced lower than the branded version, making it more attractive to patients and healthcare providers looking to reduce costs.

Regulatory Environment

Regulatory approvals and patent expirations play a crucial role in the financial trajectory of drugs like GABITRIL. The expiration of patents for GABITRIL allowed generic manufacturers to enter the market, changing the competitive landscape and financial performance of the drug.

Patient and Prescriber Preferences

Patient and prescriber preferences also influence the market dynamics. While generics are often preferred due to their lower cost, some patients and prescribers may still opt for the branded version due to perceived differences in quality or efficacy.

Future Outlook

The future outlook for GABITRIL is likely to be influenced by continued competition from generics and other antiepilepsy drugs. The market will likely see a stable but reduced revenue stream for the branded version, with generics capturing a larger share of the market.

Key Statistics

• Annual U.S. Sales: Approximately $30 million as of 2018[3].
• Generic Entry: Generic tiagabine hydrochloride was launched in 2018[3].
• Clinical Efficacy: Statistically significant reduction in partial and complex partial seizure rates compared to placebo[1].

Conclusion

The market dynamics and financial trajectory of GABITRIL are characterized by a decline in revenue due to generic competition. Despite its clinical efficacy, the branded version faces significant challenges in maintaining market share and revenue.

Key Takeaways

• GABITRIL is an effective antiepilepsy drug but faces competition from generic alternatives.
• The introduction of generics has reduced the revenue of the branded version.
• The drug remains a viable option for treating certain types of seizures, but its market share is diminishing.
• Regulatory and pricing dynamics continue to shape the market for GABITRIL.

FAQs

What is GABITRIL used for?

GABITRIL (tiagabine hydrochloride) is used to treat certain types of seizures, particularly partial and complex partial seizures.

When was GABITRIL approved by the FDA?

GABITRIL was approved by the FDA on September 30, 1997[4].

Is there a generic version of GABITRIL available?

Yes, the generic version of GABITRIL, tiagabine hydrochloride, is available in the market[3][4].

How has the introduction of generics affected GABITRIL's market dynamics?

The introduction of generics has significantly reduced the revenue and market share of the branded version of GABITRIL[3].

What are the strengths of GABITRIL tablets available in the market?

GABITRIL tablets are available in 2 mg, 4 mg, 12 mg, and 16 mg strengths[1][4].

How effective is GABITRIL in reducing seizure rates?

GABITRIL has demonstrated a statistically significant reduction in partial and complex partial seizure rates compared to placebo in clinical trials[1].