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. Seventeen 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 ENDO OPERATIONS on April 27th, 2017.
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Questions you can ask:
- What is the 5 year forecast for VIGADRONE?
- What are the global sales for VIGADRONE?
- What is Average Wholesale Price for VIGADRONE?
Summary for VIGADRONE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aucta | VIGADRONE | vigabatrin | FOR SOLUTION;ORAL | 210196-001 | Jun 21, 2018 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 |
