ROPIVACAINE HYDROCHLORIDE | N020533 | FRESENIUS KABI USA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2022-02-18 | Terminated 2022-07-27 | — | |
Fresenius Kabi USA, LLC et al v. Baxter Healthcare Corporation et al 4 patentsANDA 215691ropivacaine hydrochloride | D. Del. | 2021-07-16 | Terminated 2022-05-05 | — |
FRESENIUS KABI USA LLC, et al. WOCKHARDT USA LLC, et al. 1 patentANDA 206320ropivacaine hydrochloride | D.N.J. | 2019-11-15 | Terminated 2020-02-05 | — |
Fresenius Kabi USA, LLC et al v. Custopharm, Inc. 3 patentsANDA 211907ropivacaine hydrochloride | W.D. Tex. | 2018-08-06 | Terminated 2019-08-13 | — |
| D. Del. | 2017-01-04 | Terminated 2017-06-09 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2758 · 8 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client and at the directive of the Office of Generic Drugs, filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that FDA declare Ropivacaine Hydrochloride Injection, US | Suitability | 2024-06-10 | Partially Denied | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Lachman Consultant Services Inc on behalf of Sintetica SA FDA-2021-P-1323 · 4 docket documents Lachman Consultant Services Inc., on behalf of Sintetica SA, filed this petition requesting that the FDA determine whether the Reference Listed Drug NAROPIN (ropivacaine) injection in 50mg/10mL and 75mg/10mL strengths, approved under NDA N020533 and held by Fresenius Kabi USA LLC, was voluntarily wi | 505(q) | 2021-12-17 | Granted | Sintetica SA |
McGuireWoods LLP - Citizen Petition FDA-2013-P-1203 · 3 docket documents McGuireWoods LLP, on behalf of a client, filed this citizen petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an ANDA for Ropivacaine Hydrochloride Injection 2mg/mL in a 500mL infusion bag, using NAROPIN (Ropivacaine Hydrochloride) | Other | 2013-10-25 | Granted | — |
Navinta LLC - Citizen Petition FDA-2009-P-0601 · 6 docket documents Navinta LLC submitted this citizen petition on December 18, 2009, requesting that the FDA refrain from approving any abbreviated new drug applications (ANDA) for generic ropivacaine hydrochloride monohydrate injection (Naropin) that include a section (viii) statement to U.S. Patent No. 5,670,524 unl | 505(q) | 2010-01-04 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.