SABRIL Drug Patent Profile
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When do Sabril patents expire, and what generic alternatives are available?
Sabril is a drug marketed by Lundbeck Pharms Llc and is included in two NDAs.
The generic ingredient in SABRIL 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 Sabril
A generic version of SABRIL was approved as vigabatrin by PAR PHARM INC on April 27th, 2017.
Summary for SABRIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 12 |
| Patent Applications: | 3,877 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SABRIL |
| What excipients (inactive ingredients) are in SABRIL? | SABRIL excipients list |
| DailyMed Link: | SABRIL at DailyMed |
Recent Clinical Trials for SABRIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Washington University School of Medicine | Phase 2 |
| Kullasate Sakpichaisakul | N/A |
| Benuvia Therapeutics Inc. | Phase 3 |
Pharmacology for SABRIL
| Drug Class | Anti-epileptic Agent |
Anatomical Therapeutic Chemical (ATC) Classes for SABRIL
US Patents and Regulatory Information for SABRIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lundbeck Pharms Llc | SABRIL | vigabatrin | FOR SOLUTION;ORAL | 022006-001 | Aug 21, 2009 | AA | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Lundbeck Pharms Llc | SABRIL | vigabatrin | TABLET;ORAL | 020427-001 | Aug 21, 2009 | AB | RX | Yes | Yes | ⤷ 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 SABRIL
| 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 |
