VIGABATRIN Drug Patent Profile
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When do Vigabatrin patents expire, and what generic alternatives are available?
Vigabatrin is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Dexcel, Dr Reddys, Endo Operations, Granules, Invagen Pharms, MSN, Propel Pharma, Specgx Llc, Teva Pharms Usa, Zydus Lifesciences, Hikma, Ryan Labs, and Upsher Smith Labs. and is included in twenty-five NDAs.
The generic ingredient in VIGABATRIN 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 Vigabatrin
A generic version of VIGABATRIN was approved as vigabatrin by ENDO OPERATIONS on April 27th, 2017.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for VIGABATRIN?
- What are the global sales for VIGABATRIN?
- What is Average Wholesale Price for VIGABATRIN?
Summary for VIGABATRIN
| US Patents: | 0 |
| Applicants: | 19 |
| NDAs: | 25 |
| Finished Product Suppliers / Packagers: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 30 |
| Patent Applications: | 3,760 |
| Drug Prices: | Drug price information for VIGABATRIN |
| DailyMed Link: | VIGABATRIN at DailyMed |
Recent Clinical Trials for VIGABATRIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Amzell | Phase 3 |
| Thomas Jefferson University | Phase 2 |
| University of Florida | Phase 2 |
Pharmacology for VIGABATRIN
| Drug Class | Anti-epileptic Agent |
Medical Subject Heading (MeSH) Categories for VIGABATRIN
Anatomical Therapeutic Chemical (ATC) Classes for VIGABATRIN
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 214425-001 | Nov 13, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma Ltd | VIGABATRIN | vigabatrin | TABLET;ORAL | 215601-001 | May 10, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Upsher Smith Labs | VIGABATRIN | vigabatrin | TABLET;ORAL | 214749-001 | Jun 29, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dexcel | VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 214992-001 | May 13, 2021 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Annora Pharma | VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 213519-001 | Jan 26, 2021 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Msn | VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 215363-001 | Sep 7, 2022 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | VIGABATRIN | vigabatrin | TABLET;ORAL | 211539-001 | Jan 29, 2021 | AB | 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 VIGABATRIN
| 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 |
