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GILENYA Drug Profile
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See Plans and PricingWhich patents cover Gilenya, and when can generic versions of Gilenya launch?
Gilenya is a drug marketed by Novartis and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and eighty-six patent family members in forty-eight countries.
The generic ingredient in GILENYA is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Gilenya
A generic version of GILENYA was approved as fingolimod hydrochloride by BIOCON LTD on December 4th, 2019.
Summary for GILENYA
| International Patents: | 186 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 27 |
| Patent Applications: | 102 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for GILENYA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GILENYA |
| DailyMed Link: | GILENYA at DailyMed |
Recent Clinical Trials for GILENYA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wake Forest University Health Sciences | Early Phase 1 |
| National Cancer Institute (NCI) | Early Phase 1 |
| Mayo Clinic | Early Phase 1 |
Recent Litigation for GILENYA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Novartis Pharmaceuticals Corporation v. Apotex Inc. | 2020-01-28 |
| Novartis Pharmaceuticals Corporation v. Accord Healthcare Inc. | 2018-07-16 |
| Novartis Pharmaceuticals Corporation v. Sun Pharmaceutical Industries, Ltd. | 2018-07-13 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2017-08-16 | |
| 2017-08-15 | |
| 2017-06-09 |
Pharmacology for GILENYA
| Drug Class | Sphingosine 1-phosphate Receptor Modulator |
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Synonyms for GILENYA
| 1,3-Propanediol, 2-amino-2-(2-(4-octylphenyl)ethyl)-, hydrochloride |
| 1,3-Propanediol, 2-amino-2-[2-(4-octylphenyl)ethyl]-, hydrochloride |
| 1,3-Propanediol, 2-amino-2-[2-(4-octylphenyl)ethyl]-, hydrochloride (1:1) |
| 1346604-90-7 |
| 162359-56-0 |
| 162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720 |
| 2-(4-octylphenethyl)-2-aminopropane-1,3-diol hydrochloride |
| 2-Amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol hydrochloride |
| 2-amino-2-(2-(4-octylphenyl)ethyl)propane-1,3-diol hydrochloride |
| 2-Amino-2-(2-(4-octylphenyl)ethyl)propane-1,3-diol, HCl |
| 2-Amino-2-(4-octylphenethyl)propane-1,3-diol hydrochloride |
| 2-Amino-2-[2-(4-n-octylphenyl)ethyl]propane-1,3-diol Hydrochloride |
| 2-Amino-2-[2-(4-octyl-phenyl)-ethyl]-propane -1,3-diol hydrochloride |
| 2-AMINO-2-[2-(4-OCTYL-PHENYL)-ETHYL]-PROPANE-1,3-DIOL HCL |
| 2-amino-2-[2-(4-octylphenyl) ethyl]-1,3-propanediol hydrochloride |
| 2-Amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol hydrochloride |
| 2-Amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol, hydrochloride |
| 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol hydrochloride |
| 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol;hydrochloride |
| 359F560 |
| 4CA-0534 |
| A25158 |
| A8548 |
| AB0018286 |
| AB1008447 |
| AC-1929 |
| AC1L332T |
| AK-33554 |
| AKOS005145784 |
| AM84549 |
| AN-444 |
| AOB7477 |
| API0002703 |
| AX8041343 |
| BC679342 |
| BCP01808 |
| BCP9000705 |
| BCPP000225 |
| C-35663 |
| C19H33NO2.HCl |
| CC-28427 |
| CHEBI:63112 |
| CHEMBL544665 |
| CS-0114 |
| D04187 |
| DTXSID00167364 |
| Epitope ID:156573 |
| EX-A960 |
| F1018 |
| Fin;limod hydrochloride |
| Fingolimod (FTY-720 HCl) |
| Fingolimod (FTY720) |
| Fingolimod (FTY720) HCl |
| Fingolimod (hydrochloride) |
| Fingolimod HCl |
| Fingolimod HClFTY-720 |
| Fingolimod hydrochloride |
| Fingolimod hydrochloride (JAN/USAN) |
| Fingolimod hydrochloride [USAN] |
| Fingolimod hydrochloride FTY720 |
| Fingolimod-d4 Hydrochloride |
| Fingolimod, HCl |
| FT-0643569 |
| Fty 720 |
| Fty-720 |
| FTY-720A |
| FTY720 |
| FTY720 - Fingolimod |
| FTY720,Fingolimod |
| G926EC510T |
| Gilenia |
| Gilenya (TN) |
| GP3498 |
| HY-12005 |
| I01-1261 |
| Imusera |
| IN1328 |
| J10426 |
| KB-51874 |
| KS-00000L2J |
| KS-1172 |
| LS-120139 |
| MLS006010179 |
| MolPort-006-666-484 |
| PubChem23815 |
| Q-101363 |
| RL02083 |
| RTX-010897 |
| s5002 |
| SC-21229 |
| SCHEMBL81362 |
| SMR004701287 |
| SR-01000942237 |
| SR-01000942237-2 |
| SW219384-1 |
| SWZTYAVBMYWFGS-UHFFFAOYSA-N |
| TDI-132 |
| UNII-G926EC510T |
| W-5231 |
Paragraph IV (Patent) Challenges for GILENYA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| GILENYA | CAPSULE;ORAL | fingolimod hydrochloride | 022527 | 2018-07-19 |
| GILENYA | CAPSULE;ORAL | fingolimod hydrochloride | 022527 | 2018-07-18 |
| GILENYA | CAPSULE;ORAL | fingolimod hydrochloride | 022527 | 2014-09-22 |
US Patents and Regulatory Information for GILENYA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-002 | May 11, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-002 | May 11, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for GILENYA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-002 | May 11, 2018 | Start Trial | Start Trial |
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | Start Trial | Start Trial |
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GILENYA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3143990 | Start Trial |
| European Patent Office | 1613288 | Start Trial |
| Taiwan | I332847 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GILENYA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1613288 | 91867 | Luxembourg | Start Trial | 91867, EXPIRES: 20260317 |
| 0627406 | 1190015-6 | Sweden | Start Trial | PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317 |
| 1613288 | 107 5008-2011 | Slovakia | Start Trial | FIRST REGISTRATION NO/DATE: EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004, 20110317 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
