VIGADRONE Drug Patent Profile
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When do Vigadrone patents expire, and what generic alternatives are available?
Vigadrone is a drug marketed by Aucta and is included in one NDA.
The generic ingredient in VIGADRONE is vigabatrin. There are five drug master file entries for this compound. Eighteen 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 PAR PHARM INC on April 27th, 2017.
Summary for VIGADRONE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Formulation / Manufacturing: | see details |
DailyMed Link: | VIGADRONE at DailyMed |
Pharmacology for VIGADRONE
Drug Class | Anti-epileptic Agent |
Anatomical Therapeutic Chemical (ATC) Classes for VIGADRONE
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aucta | VIGADRONE | vigabatrin | FOR SOLUTION;ORAL | 210196-001 | Jun 21, 2018 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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/004534 Kigabeq 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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |