SABRIL Drug Patent Profile

When do Sabril patents expire, and what generic alternatives are available?

Sabril is a drug marketed by Lundbeck Pharms Llc and is included in two NDAs.

The generic ingredient in SABRIL is vigabatrin. There are five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sabril

A generic version of SABRIL was approved as vigabatrin by PH HEALTH on April 27^th, 2017.

Summary for SABRIL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	12
Drug Prices:	Drug price information for SABRIL
What excipients (inactive ingredients) are in SABRIL?	SABRIL excipients list
DailyMed Link:	SABRIL at DailyMed

See drug prices for SABRIL

Recent Clinical Trials for SABRIL

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

Sponsor	Phase
Washington University School of Medicine	Phase 2
Kullasate Sakpichaisakul	N/A
Benuvia Therapeutics Inc.	Phase 3

See all SABRIL clinical trials

Pharmacology for SABRIL

Drug Class

Anti-epileptic Agent

US Patents and Regulatory Information for SABRIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lundbeck Pharms Llc	SABRIL	vigabatrin	FOR SOLUTION;ORAL	022006-001	Aug 21, 2009	AA	RX	Yes	Yes
Lundbeck Pharms Llc	SABRIL	vigabatrin	TABLET;ORAL	020427-001	Aug 21, 2009	AB	RX	Yes	Yes

EU/EMA Drug Approvals for SABRIL

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

Market Dynamics and Financial Trajectory for SABRIL

Last updated: March 5, 2026

What is the current market status of SABRIL?

SABRIL (vigabatrin) is an anticonvulsant medication approved by the FDA in 2009 for infantile spasms and refractory complex partial seizures. Its market presence is significantly influenced by patent conditions, regulatory status, and competition from alternative therapies.

How has SABRIL’s patent landscape evolved?

SABRIL's original patent expired in the U.S. in 2018, opening the market for generic versions. The absence of patent protection has resulted in a sharp decrease in branded sales, with generics capturing most of the market share. As of 2023, only two generic manufacturers, Teva and Mylan, actively market vigabatrin generics.

What are the key drivers influencing SABRIL’s market?

Regulatory Environment

• FDA approval for infantile spasms and refractory partial seizures remains the primary label.
• Safety concerns, notably the risk of permanent vision loss, restrict use, leading to cautious prescribing practices.
• Restricted labeling limits expansion into new indications.

Competitive Landscape

• Generics dominate the market, reducing the revenue potential of SABRIL.
• Several off-label therapies for infantile spasms, including ACTH and corticosteroids, provide alternative treatment options.
• New developments in epilepsy treatment—such as cannabidiol (CBD)—pose future threats.

Market Demand

• Infantile spasm prevalence is estimated at 2-3 per 10,000 live births.
• Refractory partial seizures affect approximately 25-30% of epilepsy patients.
• Demand remains steady for approved indications but is constrained by safety and efficacy perceptions.

What are recent financial trends?

Revenue Trends

• Worldwide sales peaked around $60 million annually pre-2018.
• Post-patent expiry, sales declined sharply, with current estimates near $10 million annually.
• The decline correlates with increased generic penetration and conservative prescribing due to safety concerns.

Profitability and Cost Structure

• Branded sales historically generated margins exceeding 50%.
• Generic manufacturing reduces margins to below 10%, pressuring profitability in the segment.
• Limited R&D investment continues due to reduced revenue streams.

Market Forecasts

• Total global market for vigabatrin is projected to decline at a compound annual growth rate (CAGR) of approximately 8% over the next five years.
• Market consolidations are unlikely, given the limited number of manufacturers and safety restrictions.

What are potential future market opportunities and risks?

Opportunities

• Expansion into additional indications, pending safety profile adjustments.
• Development of formulation improvements, such as long-acting versions, to address adherence.
• Increased use in developing countries where epilepsy management resources are limited.

Risks

• Marginal market size due to safety concerns.
• Competition from newer antiepileptic drugs with better safety profiles.
• Regulatory restrictions or label updates that further limit use.

Summary table of key data points

Aspect	Details
Original FDA approval	2009
Patent expiry in the U.S.	2018
Peak annual sales	~$60 million
Current annual sales	~$10 million
Generics market share	>80%
Estimated infantile spasms prevalence	2-3 per 10,000 live births
Refractory seizure prevalence	25-30% of epilepsy patients
CAGR forecast (next 5 years)	-8%

Key Takeaways

• SABRIL's revenue significantly declined following patent expiration, with generics dominating sales.
• Safety concerns limit expansion into new indications, constraining market growth.
• Competition from newer therapies and off-label treatments diminishes its long-term market prospects.
• Opportunities remain in developing regions and improving formulations, but market size remains limited.
• Continued scrutiny from regulatory agencies may further restrict use, impacting future revenues.

FAQs

1. What is the primary use of SABRIL?
It is indicated for infantile spasms and refractory partial seizures.

2. When did patent expiration impact SABRIL’s sales?
In 2018, leading to significant sales decline due to generic market entry.

3. Are there safety concerns associated with SABRIL?
Yes; the risk of permanent vision loss restricts widespread use.

4. What are the main competitors for SABRIL?
Generic vigabatrin and alternative treatments like ACTH, corticosteroids, and newer antiepileptic drugs.

5. Will SABRIL regain market share?
Unlikely without safety profile improvements or new indications, given current competition and regulatory restrictions.

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References

[1] U.S. Food and Drug Administration. (2009). SABRIL (vigabatrin) prescribing information.
[2] IQVIA. (2023). Pharmaceutical market data.
[3] Epilepsy Foundation. (2022). Prevalence and treatment options for infantile spasms.