VIGABATRIN - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for vigabatrin and what is the scope of patent protection?
Vigabatrin
is the generic ingredient in four branded drugs marketed by Lundbeck Pharms Llc, 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, Aucta, Pyros Pharms, Hikma, and Upsher Smith Labs, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.There are five drug master file entries for vigabatrin. Eighteen suppliers are listed for this compound.
Summary for VIGABATRIN
US Patents: | 0 |
Tradenames: | 4 |
Applicants: | 21 |
NDAs: | 29 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 18 |
Raw Ingredient (Bulk) Api Vendors: | 121 |
Clinical Trials: | 30 |
Patent Applications: | 5,938 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for VIGABATRIN |
What excipients (inactive ingredients) are in VIGABATRIN? | VIGABATRIN excipients list |
DailyMed Link: | VIGABATRIN at DailyMed |
Recent Clinical Trials for VIGABATRIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Amzell | Phase 3 |
Yale University | Phase 2 |
Thomas Jefferson University | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma Ltd | VIGABATRIN | vigabatrin | TABLET;ORAL | 215601-001 | May 10, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Teva Pharms Usa | VIGABATRIN | vigabatrin | TABLET;ORAL | 209822-001 | Jan 14, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Specgx Llc | VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 212626-001 | Jul 28, 2021 | DISCN | 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 | |||
Amneal Pharms | VIGABATRIN | vigabatrin | TABLET;ORAL | 210042-001 | Jun 22, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Accord Hlthcare | VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 214425-001 | Nov 13, 2020 | DISCN | 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.