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 | CAND | 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 |
|---|---|---|---|---|
Amendment to Suitability Petition from Pharmobedient Consulting, LLC FDA-2026-P-6537 Pharmobedient Consulting, LLC filed an amendment to a suitability petition, though the provided text does not specify which drug or product the petition concerns, what specific regulatory pathway such as an ANDA or NDA is involved, or what particular action is being requested in this amendment. | Suitability | 2026-06-25 | Open | Pharmobedient Consulting, LLC |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2026-P-6537 Pharmobedient Consulting, LLC filed this suitability petition requesting FDA evaluation of whether a particular drug product is suitable for designation as an eligible product under the REMS (Risk Evaluation and Mitigation Strategy) program or for other regulatory pathways. The petition seeks FDA de | Suitability | 2026-06-08 | Open | Pharmobedient Consulting, LLC |
Citizen Petition from Kaylin Bower FDA-2026-P-0775 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 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 | — | — | — | — |