VIGADRONE Drug Patent Profile

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

Vigadrone is a drug marketed by Bora and is included in one NDA.

The generic ingredient in VIGADRONE is vigabatrin. There is one drug master file entry 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 Vigadrone

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

Summary for VIGADRONE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Patent Applications:	4,675
DailyMed Link:	VIGADRONE at DailyMed

Pharmacology for VIGADRONE

Drug Class

Anti-epileptic Agent

US Patents and Regulatory Information for VIGADRONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bora	VIGADRONE	vigabatrin	FOR SOLUTION;ORAL	210196-001	Jun 21, 2018	AA	RX	No	No

EU/EMA Drug Approvals for VIGADRONE

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

Last updated: July 26, 2026

Vigadrone Market Dynamics and Financial Trajectory (Revenue, Access, Competition, and IP-Driven Risk)

Vigadrone’s financial trajectory is driven by (1) exclusivity and patent/market-entry timing (including generic and biosimilar risk depending on formulation/ingredient class), (2) payer access and channel mix (hospital vs retail), and (3) competitive pressure from therapeutically comparable products and any copycat label launches. Vigadrone’s near-to-mid term revenue path typically follows a standard shape: early ramp tied to formulary adoption and reimbursement coverage, plateau as share stabilizes, then step-down risk around the first meaningful competitive entry window tied to FDA exclusivity and Orange Book/patent expiration or Paragraph IV challenges.

No market-sizing, revenue, utilization, pricing, or FDA/Orange Book/IP status data for Vigadrone is provided in the prompt. Under the operating constraints, a complete and accurate market-and-financial write-up cannot be produced.