FINGOLIMOD HYDROCHLORIDE | N022527 | NOVARTIS PHARMACEUTICALS CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Novartis Pharmaceuticals Corporation v. Handa Neuroscience, LLC et al 2 patentsfingolimod | CAND | 2021-05-06 | Terminated 2022-03-18 | — |
Shilpa Pharma, Inc. v. Novartis Pharmaceuticals Corporation 1 patentfingolimod hydrochloride | D. Del. | 2021-04-20 | Terminated 2025-10-14 | — |
Novartis Pharmaceuticals Corporation v. Sun Pharmaceutical Industries, Ltd., et al. 1 patentANDA 208014Fingolimod | D. Del. | 2018-07-13 | Terminated 2022-04-11 | — |
| 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 a suitability petition under section 505(j)(2)(C) of the FDC Act requesting FDA approval to submit an ANDA for Fingolimod Oral Solution, 0.5 mg/5 mL, which differs from the Reference Listed Drug GILENYA (Fingolimod HCl Capsule, approved under NDA 022527) only in d | Suitability | 2026-06-25 | Open | Pharmobedient Consulting |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2026-P-6537 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Fingolimod Oral Solution in strengths of 0.5 mg/5 mL and 15 mg/150 mL suitable for submission in an ANDA, with the Reference Listed Dru | Suitability | 2026-06-08 | Open | Pharmobedient Consulting |
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 | — | — | — | — |