VIGABATRIN - Generic Drug Details

What are the generic drug sources for vigabatrin and what is the scope of patent protection?

Vigabatrin is the generic ingredient in five branded drugs marketed by Lundbeck Pharms Llc, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Dexcel, Dr Reddys, Granules, Invagen Pharms, MSN, Ph Health, Propel Pharma, Specgx Llc, Teva Pharms Usa, Zydus Lifesciences, Aucta, Pyros Pharms, Carnegie, Hikma, and Upsher Smith Labs, and is included in thirty NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vigabatrin has four patent family members in two countries.

There are five drug master file entries for vigabatrin. Seventeen suppliers are listed for this compound.

Summary for VIGABATRIN

International Patents:	4
US Patents:	2
Tradenames:	5
Applicants:	22
NDAs:	30
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	32
Patent Applications:	6,640
Drug Prices:	Drug price trends for VIGABATRIN
What excipients (inactive ingredients) are in VIGABATRIN?	VIGABATRIN excipients list
DailyMed Link:	VIGABATRIN at DailyMed

See drug prices for VIGABATRIN

Recent Clinical Trials for VIGABATRIN

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

Sponsor	Phase
Heather Olson	PHASE1
Boston Children's Hospital Translational Research Program (TRP) Pappendick Family Therapeutic Acceleration Award	PHASE1
All India Institute of Medical Sciences	PHASE2

See all VIGABATRIN clinical trials

Pharmacology for VIGABATRIN

Drug Class

Anti-epileptic Agent

Medical Subject Heading (MeSH) Categories for VIGABATRIN

Anticonvulsants

Enzyme Inhibitors

GABA Agents

Anatomical Therapeutic Chemical (ATC) Classes for VIGABATRIN

N03AG	Fatty acid derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for VIGABATRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pyros Pharms	VIGAFYDE	vigabatrin	SOLUTION;ORAL	217684-001	Jun 17, 2024		RX	Yes	Yes			Y
Zydus Lifesciences	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	214671-001	Mar 2, 2023		DISCN	No	No
Dexcel	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	214992-001	May 13, 2021		DISCN	No	No
Lundbeck Pharms Llc	SABRIL	vigabatrin	FOR SOLUTION;ORAL	022006-001	Aug 21, 2009	AA	RX	Yes	Yes
Dr Reddys	VIGABATRIN	vigabatrin	TABLET;ORAL	211539-001	Jan 29, 2021	AB	RX	No	No
Ph Health	VIGABATRIN	vigabatrin	FOR SOLUTION;ORAL	208218-001	Apr 27, 2017	AA	RX	No	No
Teva Pharms Usa	VIGABATRIN	vigabatrin	TABLET;ORAL	209822-001	Jan 14, 2019	AB	RX	No	No

EU/EMA Drug Approvals for VIGABATRIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ORPHELIA Pharma SAS	Kigabeq	vigabatrin	EMEA/H/C/004534Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for:Treatment in monotherapy of infantile spasms (West's syndrome).Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.	Authorised	no	no	no	2018-09-20

International Patents for VIGABATRIN

Country	Patent Number	Title	Estimated Expiration
United Kingdom	202103724
World Intellectual Property Organization (WIPO)	2024058812
United Kingdom	2591389
World Intellectual Property Organization (WIPO)	2020039262

Market Dynamics and Financial Trajectory for Vigabatrin

Last updated: February 12, 2026

Vigabatrin is an antiepileptic drug marketed under the brand name Sabril, primarily used to treat refractory epilepsy and infantile spasms. Its market history, current positioning, and potential future trajectory depend on regulatory factors, competition, clinical utility, and manufacturing status.

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What Are the Key Market Drivers for Vigabatrin?

Clinical Indications:
Vigabatrin is approved primarily for refractory complex partial seizures and infantile spasms in the US and Europe. Its use in treatment-resistant cases, where alternatives are limited, sustains demand despite safety concerns.

Safety Profile and Regulatory Status:
A major limitation is the risk of permanent vision loss, leading to strict risk management and monitoring requirements. The US FDA restricted its use in 2010, allowing only in cases of infantile spasms where other treatments failed, heightening prescription caution. Regulatory agencies in Europe maintain tighter monitoring protocols, influencing market access and volume.

Market Penetration and Competition:
Existing treatments such as vigabatrin’s main competitors—vigabatrin's alternatives for infantile spasms include corticosteroids and ACTH, while for epilepsy, drugs like levetiracetam, topiramate, and lacosamide serve as alternatives. The limited scope of vigabatrin’s approved indications constrains market growth.

Manufacturing and Supply:
Teva Pharmaceuticals retains manufacturing rights for vigabatrin in multiple regions. Supply chain stability influences availability, but no major disruptions have been reported recently.

Pricing and Reimbursement:
Pricing in current markets ranges from $10 to $50 per tablet, influenced heavily by safety monitoring requirements. Reimbursement policies in the US and Europe restrict copayment levels, impacting revenue.

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How Has the Market Evolved Over Time?

Historical Growth:
Since its patent expiration in 2004, generic competition increased, leading to a price decline. Used predominantly in niche indications, vigabatrin’s global sales peaked around $200 million in 2008 (source: EvaluatePharma).

Regulatory Impact:
Post-2010 restrictions in the US have reduced off-label use and overall sales. In Europe, sales slowed but remained stable in certain centers due to ongoing clinical use.

Patent and Exclusivity:
The patent expired in 2004; no recent data indicates new patent filings or exclusivities. The absence of patent protection limits pricing power and incentivizes generic competition.

Market Share Dynamics:
Vigabatrin’s share in the antiepileptic market remains limited due to safety concerns, with other drugs capturing larger segments. The drug retains niche positioning for infantile spasms.

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What Are the Future Market Opportunities and Risks?

Potential for Expanded Indications:
Research into new applications, such as in certain neuroplasticity disorders, could expand the market. However, safety concerns have hindered broader approval.

Emerging Competition:
Newer antiepileptic agents with improved safety profiles are capturing market share. Gene therapy and precision medicine approaches threaten to replace older drugs like vigabatrin.

Regulatory Changes:
Enhanced safety monitoring and potential label updates could restrict or expand use. Any lifting of restrictions would likely be gradual and uncertain.

Off-Label Use and Clinical Trials:
Current use remains largely confined to approved indications. Ongoing trials for refractory epilepsy suggest limited but steady potential for growth if safety concerns are managed.

Market Size Estimates:
Global epilepsy treatment market projected to reach $5 billion by 2027 (source: MarketsandMarkets), with vigabatrin constituting less than 1% due to restrictive indications.

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Financial Trajectory Analysis

Year	Estimated Global Sales	Key Factors	Future Potential
2008	~$200 million	Peak after patent expiry, generic competition	Declined after 2010 restrictions
2015	<$50 million	US restrictions reduced use, market stabilization	Limited growth, niche status
2023	~$20 million	Market remains stable, off-label use minimal	No major uptick predicted

Revenue Prediction (Next 5 Years):
Without regulatory changes, sales are expected to stay within an $10-$25 million range annually, driven by niche indications and ongoing clinical use in infantile spasms.

R&D Investment Outlook:
Limited investment is projected unless new indications or formulations emerge, given safety constraints and market saturation.

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Key Takeaways

• Vigabatrin’s market is constrained by safety concerns, leading to restricted indications and declining revenues.
• Its primary revenue sources are niche clinical indications such as infantile spasms.
• Generics dominate, limiting pricing power and profits.
• Opportunities depend on safety profile improvements or new therapeutic claims, which remain uncertain.
• The market trajectory presents limited upside without significant regulatory or clinical breakthroughs.

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FAQs

Q1: Why did vigabatrin’s US sales decline after 2010?
Regulatory restrictions limited its use due to the risk of vision loss, restricting prescribing to specific cases when other treatments fail.

Q2: Are there any advances that could revive vigabatrin’s market?
Developments in safer formulations or new indications demonstrating efficacy with fewer side effects could potentially revive interest, but significant progress is unreported.

Q3: How does vigabatrin compare price-wise to other antiepileptic drugs?
Pricing varies from $10 to $50 per tablet, but generic competition and safety monitoring costs reduce profitability.

Q4: What is the outlook for vigabatrin in pediatric indications?
It remains a second-line treatment for infantile spasms with stable but modest demand, primarily in specialized centers.

Q5: Is vigabatrin likely to regain regulatory approval in the US for broader indications?
It is unlikely absent significant safety improvements or new compelling clinical data. The risk profile limits potential for expanded labeling.

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References

1. EvaluatePharma. "Vigabatrin Global Sales Data." 2022.
2. FDA. "Vigabatrin (Sabril) Warning and Restrictions." 2010.
3. MarketsandMarkets. "Epilepsy Treatment Market Outlook." 2022.