Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
BENDAMUSTINE HYDROCHLORIDE | N022303 | CEPHALON
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Cephalon Inc. v. Sun Pharma Global FZE et al 2 patentsANDA 205653bendamustine hydrochloride | D. Del. | 2013-12-26 | Terminated 2015-03-26 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Teva Pharmaceutical Industries, Ltd. FDA-2015-P-3980 Teva Pharmaceutical Industries, Ltd. filed this petition under section 21 USC 355(q) on behalf of its subsidiary Cephalon, Inc., requesting that the FDA refrain from approving any abbreviated new drug application (ANDA) referencing Treanda (bendamustine hydrochloride) before May 1, 2016, if the prop | 505(q) | 2015-10-30 | Denied | Teva Pharmaceutical Industries |
Citizen Petition from Teva Pharmaceuticals (Cephalon, Inc) FDA-2015-P-1431 Teva Pharmaceuticals submitted this citizen petition under section 355(q) on behalf of its subsidiary Cephalon, requesting that FDA not approve any abbreviated new drug application for bendamustine (Treanda) referencing the chronic lymphocytic leukemia indication until expiration of the drug's orpha | 505(q) Stay Request | 2015-04-30 | Denied | Teva Pharmaceuticals (Cephalon |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.