DrugPatentWatch Database Preview
GILENYA Drug Profile
Which 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-four 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. One supplier is listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.
Summary for GILENYA
| International Patents: | 184 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 109 |
| Clinical Trials: | 27 |
| Patent Applications: | 101 |
| 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 |
Generic Entry Opportunity Date for GILENYA
Generic Entry Date for GILENYA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for GILENYA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wake Forest University Health Sciences | Early Phase 1 |
| Mayo Clinic | Early Phase 1 |
| National Cancer Institute (NCI) | Early Phase 1 |
Recent Litigation for GILENYA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Novartis Pharmaceuticals Corporation v. Accord Healthcare Inc. | 2018-07-16 |
| Novartis Pharmaceuticals Corporation v. Apotex Inc. | 2018-07-13 |
| Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc. | 2018-07-13 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Sun Pharmaceutical Industries, Ltd. | 2017-08-16 |
| Actavis Elizabeth LLC | 2017-08-15 |
| Argentum Pharmaceuticals LLC | 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 | 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 | ||||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | RX | Yes | Yes | 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 |
|---|---|---|
| Slovenia | 2316431 | Start Trial |
| Hong Kong | 1214758 | Start Trial |
| Denmark | 2694037 | Start Trial |
| Guatemala | 201300227 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GILENYA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1613288 | C20110013 00043 | Estonia | Start Trial | PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011 |
| 1613288 | C300497 | Netherlands | Start Trial | PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317 |
| 0627406 | 1190015-6 | Sweden | Start Trial | PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317 |
| 0627406 | C00627406/01 | Switzerland | Start Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
