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 four patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and forty-six patent family members in fifty 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: | 246 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 139 |
| Clinical Trials: | 32 |
| Patent Applications: | 384 |
| Formulation / Manufacturing: | see details |
| 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 |
| Genuine Research Center, Egypt | Phase 1 |
| Hikma Pharmaceuticals LLC | 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 four US patents.
Patents protecting GILENYA
Dosage regimen of an S1P receptor modulator
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS BY DETERMINING VARICELLA ZOSTER VIRUS (VZV) STATUS AND VACCINATING PRIOR TO COMMENCING TREATMENT
Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
S1P receptor modulators for treating relasping-remitting multiple sclerosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Patent: 4661
Patent: FORMULACIONES
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 12236357
Patent: Formulations comprising 2 -amino- 2- [2- (4 - octylphenyl) ethyl] propane -1, 3 - diol
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013024430
Patent: formulações compreendendo 2-amino-2-[2-(4-octilfenil)etil]propano-1,3-diol
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
China
Patent: 3476400
Patent: Formulations comprising 2-amino-2-[2-(4 - octylphenyl) ethyl] propane -1, 3-diol
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 71459
Patent: Formulaciones que comprenden 2-amino-2-[2- (4-octil-fenil)-etil] -propano-1,3-diol
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0170021
Estimated Expiration: ⤷ Sign Up
Patent: 0200249
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 18423
Estimated Expiration: ⤷ Sign Up
Patent: 22868
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 94037
Estimated Expiration: ⤷ Sign Up
Patent: 43990
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 13012912
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2-(4-OCTIL-FENIL)-ETIL]-PROPANO-1,3-DIOL
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
Patent: 1391442
Patent: ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ
Estimated Expiration: ⤷ Sign Up
Patent: 1790436
Patent: ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
Guatemala
Patent: 1300227
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-(2-(4-OCTIL-FENIL)-ETIL)-PROPANO-1,3-DIOL
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Hungary
Patent: 31286
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Japan
Patent: 19101
Estimated Expiration: ⤷ Sign Up
Patent: 14509652
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Lithuania
Patent: 94037
Estimated Expiration: ⤷ Sign Up
Patent: 43990
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 3746
Patent: FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL
Estimated Expiration: ⤷ Sign Up
Patent: 5633
Patent: FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
Morocco
Patent: 981
Patent: FORMULATIONS COMPRENANT 2-AMINO-2-2-4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5023
Patent: Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 140162
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2-(4-OCTIL-FENIL)-ETIL]-PROPANO-1,3-DIOL
Estimated Expiration: ⤷ Sign Up
Patent: 170913
Patent: FORMULACIONES QUE COMPRENDEN 2-AMINO-2-[2-(4-OCTIL-FENIL)-ETIL]-PROPANO-1,3-DIOL
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 94037
Estimated Expiration: ⤷ Sign Up
Patent: 43990
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 94037
Estimated Expiration: ⤷ Sign Up
Patent: 43990
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Singapore
Patent: 3256
Patent: FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 94037
Estimated Expiration: ⤷ Sign Up
Patent: 43990
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1306636
Patent: FORMULAIONS COMPRISING 2 -AMINO- 2-[2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2027014
Estimated Expiration: ⤷ Sign Up
Patent: 140014194
Patent: FORMULATIONS COMPRISING 2-AMINO-2-[2-(4-OCTYLPHENYL)ETHYL]PROPANE-1,3-DIOL
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 10966
Estimated Expiration: ⤷ Sign Up
Patent: 73482
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 28958
Estimated Expiration: ⤷ Sign Up
Patent: 1244711
Patent: Formulations
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 13000396
Patent: FORMULATIONS COMPRISING 2 -AMINO- 2- [2- (4 - OCTYLPHENYL) ETHYL] PROPANE -1, 3 - DIOL
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 2857
Patent: ПРЕПАРАТ, ЩО МІСТИТЬ 2-АМІНО-2-[2-(4-ОКТИЛФЕНІЛ)ЕТИЛ]ПРОПАН-1,3-ДІОЛ
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Germany | 122011100012 | ⤷ Sign Up | |
| Spain | 2773482 | ⤷ Sign Up | |
| Norway | 2011016 | ⤷ Sign Up | |
| Taiwan | I332847 | ⤷ Sign Up | |
| Russian Federation | 2012117561 | СПОСОБ И СИСТЕМА ДОСТУПА К ДАННЫМ О ПАЦИЕНТАХ | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GILENYA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0627406 | SPC/GB11/026 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317 |
| 1613288 | PA2011010 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FINGOLIMODUM; REGISTRATION NO/DATE: EU/1/11/677/001, 2011 03 17 EU/1/11/677/002, 2011 03 17 EU/1/11/677/003, 2011 03 17 EU/1/11/677/004 20110317 |
| 1613288 | C01613288/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: FINGOLOMOD; REGISTRATION NO/DATE: SWISSMEDIC 60916 20110103 |
| 0627406 | 2011020 | Ireland | ⤷ Sign Up | PRODUCT: GILENYA FINGOLIMOD AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF REGISTRATION NO/DATE: IRELAND EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011; FIRST REGISTRATION NO/DATE: EUROPEAN UNION EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011 |
| 0627406 | 91832 | Luxembourg | ⤷ Sign Up | 91832, EXPIRES: 20181018 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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