ELUXADOLINE | A213511 | AUROBINDO PHARMA LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Allergan USA, Inc., et al. v. MSN Laboratories Private Limited, et al. 6 patentsANDA 213511, 213613, 213427, 213576, 213447, 213522eluxadoline | D. Del. | 2019-09-13 | Terminated 2025-01-02 | — |
| D. Del. | 2019-09-06 | Terminated 2022-02-09 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Allergan Holdings Unlimited Company FDA-2019-P-2537 · 6 docket documents Allergan Holdings Unlimited Company filed this citizen petition under 21 U.S.C. § 355 requesting that FDA publish updated guidance requiring clinical endpoint testing for generic versions of VIBERZI (eluxadoline) tablets, refuse to receive or approve any abbreviated new drug application (ANDA) refer | 505(q) | 2019-05-24 | Withdrawn | Allergan Holdings Unlimited Company |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.