NICARDIPINE HYDROCHLORIDE | N019734 | CHIESI USA INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2015-00006 | 7612102 | IPR | Sandoz Inc. | Institution Denied | 2014-10-01 | — |
| IPR2015-00008 | 7659291 | IPR | Sandoz Inc. | Institution Denied | 2014-10-01 | — |
| IPR2015-00005 | 8455524 | IPR | Sandoz Inc. | Institution Denied | 2014-10-01 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Cornerstone Biopharma Inc. et al v. Exela Pharma Sciences LLC et al 2 patentsnicardipine hydrochloride | D. Del. | 2013-07-24 | Terminated 2015-12-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Teligent Pharma, Inc. FDA-2017-P-6479 Teligent Pharma, Inc. filed this petition requesting that the FDA designate an additional Reference Listed Drug for Nicardipine Hydrochloride Injection under Section 505(j) of the FDC Act, because the currently designated RLD, CARDENE Injection (NDA 019734), is not available in the market, thereby p | 505(q) | 2017-11-14 | Denied | Teligent Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.