FINGOLIMOD HYDROCHLORIDE | N022527 | NOVARTIS PHARMACEUTICALS CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2023-01-11 | Active | — | |
| D. Del. | 2022-03-21 | Terminated 2022-10-26 | — | |
| D. Del. | 2021-10-27 | Active | — | |
Novartis Pharmaceuticals Corporation v. Handa Neuroscience, LLC et al 2 patentsfingolimod | N.D. Cal. | 2021-05-06 | Terminated 2022-03-18 | — |
| D. Del. | 2021-05-04 | Terminated 2022-10-26 | — | |
Shilpa Pharma, Inc. v. Novartis Pharmaceuticals Corporation 1 patentfingolimod hydrochloride | D. Del. | 2021-04-20 | Terminated 2025-10-14 | — |
| D. Del. | 2019-06-17 | Terminated 2020-10-29 | — | |
| D. Del. | 2018-07-13 | Terminated 2022-04-20 | — | |
Novartis Pharmaceuticals Corporation v. Sun Pharmaceutical Industries, Ltd., et al. 1 patentANDA 208014Fingolimod | D. Del. | 2018-07-13 | Terminated 2022-04-11 | — |
| D. Del. | 2018-07-13 | Terminated 2019-03-19 | — | |
| D. Del. | 2016-04-22 | Terminated 2019-05-02 | — | |
| S.D. Fla. | 2015-10-28 | Terminated 2015-11-23 | — | |
Novartis AG et al v. HEC Pharm Co. Ltd. et al 1 patentANDA 207939Fingolimod Hydrochloride | D. Del. | 2015-02-11 | Terminated 2017-06-09 | — |
| D. Del. | 2015-02-11 | Terminated 2017-06-09 | — | |
| D.N.J. | 2014-12-17 | Terminated 2015-03-18 | — | |
Novartis AG et al v. Actavis Elizabeth LLC et al 1 patentANDA 207972Fingolimod Hydrochloride | D. Del. | 2014-12-16 | Terminated 2017-06-09 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2026-P-6537 · 9 docket documents Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an abbreviated new drug application for Fingolimod Oral Solution at strengths 0.5 mg/5 mL and 15 mg/150 mL, which differs from the re | Suitability | 2026-06-08 | Open | Pharmobedient Consulting, LLC |
Citizen Petition from Kaylin Bower FDA-2026-P-0775 · 2 docket documents Kaylin Bower filed this citizen petition with the FDA on January 24, 2026, requesting that the agency correct or remove misleading statements in FDA approval tables for multiple sclerosis drugs including Kesimpta, Aubagio, Ponvory, Gilenya, Mayzent, and Zeposia that present relative risk reductions | Other | 2026-01-27 | Open | Kaylin Bower |
Citizen Petition from Teva Pharmaceutical Industries Ltd. FDA-2013-P-0025 · 3 docket documents Teva Pharmaceutical Industries Ltd. filed this citizen petition on December 31, 2012, pursuant to 21 C.F.R. §10.30 and sections 505(b) and 505(s) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA refrain from approving any new drug or biological product (NDA or BLA) for the treatm | 505(q) | 2013-01-09 | Denied | Teva Pharmaceutical Industries Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 10543179 | Dec 25, 2027 | — | — | — | — |