GILENYA Drug Patent Profile
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Which patents cover Gilenya, and what generic alternatives are available?
Gilenya is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has ninety-eight patent family members in thirty-nine countries.
The generic ingredient in GILENYA is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gilenya
A generic version of GILENYA was approved as fingolimod hydrochloride by BIOCON LTD on December 4th, 2019.
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Summary for GILENYA
International Patents: | 98 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 32 |
Patent Applications: | 389 |
Drug Prices: | Drug price information for GILENYA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GILENYA |
What excipients (inactive ingredients) are in GILENYA? | GILENYA excipients list |
DailyMed Link: | GILENYA at DailyMed |


Recent Clinical Trials for GILENYA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The Methodist Hospital Research Institute | Phase 2 |
Hikma Pharmaceuticals LLC | Phase 1 |
Genuine Research Center, Egypt | Phase 1 |
Pharmacology for GILENYA
Drug Class | Sphingosine 1-phosphate Receptor Modulator |
Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Paragraph IV (Patent) Challenges for GILENYA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
GILENYA | Capsules | fingolimod hydrochloride | 0.25 mg | 022527 | 1 | 2018-07-19 |
GILENYA | Capsules | fingolimod hydrochloride | 0.5 mg | 022527 | 19 | 2014-09-22 |
US Patents and Regulatory Information for GILENYA
GILENYA is protected by two US patents.
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 | 9,592,208*PED | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | RX | Yes | Yes | 10,543,179 | ⤷ Try for Free | ⤷ Try for Free | |||
>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 | 022527-001 | Sep 21, 2010 | 6,004,565 | ⤷ Try for Free |
Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-002 | May 11, 2018 | 5,604,229*PED | ⤷ Try for Free |
Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | 5,604,229*PED | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GILENYA
When does loss-of-exclusivity occur for GILENYA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 5749
Patent: FORMULACIONES
Estimated Expiration: ⤷ Try for Free
Patent: 4661
Patent: FORMULACIONES
Estimated Expiration: ⤷ Try for Free
Australia
Patent: 12236357
Patent: Formulations comprising 2 -amino- 2- [2- (4 - octylphenyl) ethyl] propane -1, 3 - diol
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2013024430
Patent: formulações compreendendo 2-amino-2-[2-(4-octilfenil)etil]propano-1,3-diol
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 31600
Patent: FORMULATIONS COMPRENANT 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷ Try for Free
Chile
Patent: 13002810
Patent: Composicion farmaceutica solida oral que comprende a) un compuesto 2-amino-2-[2-(4-octil-fenil)-etil]-propano-1,3-diol (fingolimod) en una cantidad de 0,5 mg o menos, o una sal del mismo, b) un relleno y c) un estabilizante que comprende una ciclodextrina; y su uso para tratar una enfermedad autoinmune tal como esclerosis multiple.
Estimated Expiration: ⤷ Try for Free
China
Patent: 3476400
Patent: Formulations comprising 2-amino-2-[2-(4 - octylphenyl) ethyl] propane -1, 3-diol
Estimated Expiration: ⤷ Try for Free
Colombia
Patent: 71459
Patent: Formulaciones que comprenden 2-amino-2-[2- (4-octil-fenil)-etil] -propano-1,3-diol
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0170021
Estimated Expiration: ⤷ Try for Free
Patent: 0200249
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 18423
Estimated Expiration: ⤷ Try for Free
Patent: 22868
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 94037
Estimated Expiration: ⤷ Try for Free
Patent: 43990
Estimated Expiration: ⤷ Try for Free
Ecuador
Patent: 13012912
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2-(4-OCTIL-FENIL)-ETIL]-PROPANO-1,3-DIOL
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 7721
Patent: ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷ Try for Free
Patent: 5686
Patent: ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷ Try for Free
Patent: 1391442
Patent: ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ
Estimated Expiration: ⤷ Try for Free
Patent: 1790436
Patent: ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 94037
Patent: FORMULATIONS COMPRENANT 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷ Try for Free
Patent: 43990
Patent: FORMULATIONS COMPRENANT 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷ Try for Free
Guatemala
Patent: 1300227
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-(2-(4-OCTIL-FENIL)-ETIL)-PROPANO-1,3-DIOL
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 90309
Patent: 包含 -氨基- -辛基苯基 乙基 丙- -二醇的製劑 (FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL]PROPANE - 1, 3 - DIOL 2--2-[2-(4-)]-13-)
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 31286
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 8250
Patent: תכשירים המכילים 2-אמינו-2-[2-(4-אוקטילפניל)אתיל]פרופאנ-1,3-דיול (Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 19101
Estimated Expiration: ⤷ Try for Free
Patent: 14509652
Estimated Expiration: ⤷ Try for Free
Jordan
Patent: 77
Patent: تركيبات تتالف من 2-أمينو-2- [ 2- ( 4- أكتيل فينيل ) إثيل ] بروبان - 3, 1- ديول (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷ Try for Free
Lithuania
Patent: 94037
Estimated Expiration: ⤷ Try for Free
Patent: 43990
Estimated Expiration: ⤷ Try for Free
Malaysia
Patent: 3746
Patent: FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL
Estimated Expiration: ⤷ Try for Free
Patent: 5633
Patent: FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 2522
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2- (4-OCTIL-FENIL) -ETIL] -PROPANO-1, 3-DIOL. (FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL.)
Estimated Expiration: ⤷ Try for Free
Patent: 13011415
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2- (4-OCTIL-FENIL) -ETIL] -PROPANO-1, 3-DIOL. (FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL.)
Estimated Expiration: ⤷ Try for Free
Morocco
Patent: 981
Patent: FORMULATIONS COMPRENANT 2-AMINO-2-2-4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 5023
Patent: Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
Estimated Expiration: ⤷ Try for Free
Peru
Patent: 140162
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2-(4-OCTIL-FENIL)-ETIL]-PROPANO-1,3-DIOL
Estimated Expiration: ⤷ Try for Free
Patent: 170913
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2-(4-OCTIL-FENIL)-ETIL]-PROPANO-1,3-DIOL
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 94037
Estimated Expiration: ⤷ Try for Free
Patent: 43990
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 94037
Estimated Expiration: ⤷ Try for Free
Patent: 43990
Estimated Expiration: ⤷ Try for Free
Serbia
Patent: 917
Patent: FORMULACIJE KOJE SADRŽE 2-AMINO-2-[2-(4-OKTILFENIL)ETIL]PROPAN-1,3-DIOL (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL)
Estimated Expiration: ⤷ Try for Free
Singapore
Patent: 3256
Patent: FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 94037
Estimated Expiration: ⤷ Try for Free
Patent: 43990
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 1306636
Patent: FORMULAIONS COMPRISING 2 -AMINO- 2-[2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 2027014
Estimated Expiration: ⤷ Try for Free
Patent: 140014194
Patent: FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 10966
Estimated Expiration: ⤷ Try for Free
Patent: 73482
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 28958
Estimated Expiration: ⤷ Try for Free
Patent: 1244711
Patent: Formulations
Estimated Expiration: ⤷ Try for Free
Tunisia
Patent: 13000396
Patent: FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷ Try for Free
Ukraine
Patent: 2857
Patent: ПРЕПАРАТ, ЩО МІСТИТЬ 2-АМІНО-2-[2-(4-ОКТИЛФЕНІЛ)ЕТИЛ]ПРОПАН-1,3-ДІОЛ
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering GILENYA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 3143990 | ⤷ Try for Free | |
European Patent Office | 2959894 | MODULATEURS DU RÉCEPTEUR S1P POUR TRAITER LA SCLÉROSE EN PLAQUES (S1P RECEPTOR MODULATORS FOR TREATING MULTIPLE SCLEROSIS) | ⤷ Try for Free |
Spain | 2887042 | ⤷ Try for Free | |
Serbia | 59917 | FORMULACIJE KOJE SADRŽE 2-AMINO-2-[2-(4-OKTILFENIL)ETIL]PROPAN-1,3-DIOL (FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL) | ⤷ Try for Free |
Ukraine | 112857 | ПРЕПАРАТ, ЩО МІСТИТЬ 2-АМІНО-2-[2-(4-ОКТИЛФЕНІЛ)ЕТИЛ]ПРОПАН-1,3-ДІОЛ | ⤷ Try for Free |
Tunisia | 2013000396 | FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL | ⤷ Try for Free |
Japan | 6931019 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GILENYA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1613288 | 2011C/030 | Belgium | ⤷ Try for Free | PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322 |
1613288 | 28/2011 | Austria | ⤷ Try for Free | PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 20110317 |
0627406 | C00627406/01 | Switzerland | ⤷ Try for Free | FORMER REPRESENTATIVE: BOHEST AG, CH |
0627406 | 1190015-6 | Sweden | ⤷ Try for Free | PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317 |
0627406 | CA 2011 00015 | Denmark | ⤷ Try for Free | |
1613288 | C 2011 005 | Romania | ⤷ Try for Free | PRODUCT NAME: FINGOLIMOD SI SARURILE SALE ACCEPTABILE FARMACEUTIC INSPECIAL SARE CLORHIDRAT 2-AMINO-2[2-(4-OCTILFENIL)ETIL]PROPAN-1,3 DIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/677/001, RO EU/1/11/677/002, RO EU/1/11/677/003, RO EU/1/11/677/004; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/677/001, EMEA EU/1/11/677/002, EMEA EU/1/11/677/003, EMEA EU/1/11/677/004; DATE OF FIRST AUTHORISATION IN EEA: 20110317 |
1613288 | 1190025-5 | Sweden | ⤷ Try for Free | PERIOD OF VALIDITY (FROM - UNTIL): 20240407 - 20260321 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for GILENYA
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