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 thirty-nine 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. Fourteen 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 SUN PHARM on December 4th, 2019.
Summary for GILENYA
| International Patents: | 239 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 136 |
| Clinical Trials: | 32 |
| Patent Applications: | 514 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for GILENYA
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
S1P receptor modulators for treating relasping-remitting multiple sclerosis
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 12236357
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2013024430
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 31600
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 13002810
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3476400
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 71459
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0170021
Estimated Expiration: ⤷ Try a Trial
Patent: 0200249
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 18423
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 94037
Estimated Expiration: ⤷ Try a Trial
Patent: 43990
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 13012912
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 7721
Estimated Expiration: ⤷ Try a Trial
Patent: 5686
Estimated Expiration: ⤷ Try a Trial
Patent: 1391442
Estimated Expiration: ⤷ Try a Trial
Patent: 1790436
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 94037
Estimated Expiration: ⤷ Try a Trial
Patent: 43990
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 1300227
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 90309
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 31286
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8250
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 19101
Estimated Expiration: ⤷ Try a Trial
Patent: 14509652
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 77
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 94037
Estimated Expiration: ⤷ Try a Trial
Patent: 43990
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 3746
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 2522
Estimated Expiration: ⤷ Try a Trial
Patent: 13011415
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 981
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 5023
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 140162
Estimated Expiration: ⤷ Try a Trial
Patent: 170913
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 94037
Estimated Expiration: ⤷ Try a Trial
Patent: 43990
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 94037
Estimated Expiration: ⤷ Try a Trial
Patent: 43990
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 917
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 3256
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 94037
Estimated Expiration: ⤷ Try a Trial
Patent: 43990
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1306636
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2027014
Estimated Expiration: ⤷ Try a Trial
Patent: 140014194
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 10966
Estimated Expiration: ⤷ Try a Trial
Patent: 73482
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 28958
Estimated Expiration: ⤷ Try a Trial
Patent: 1244711
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 13000396
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 2857
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Norway | 20100250 | ⤷ Try a Trial | |
| South Korea | 20110005320 | SOLID PHARMACEUTICAL COMPOSITIONS COMPRISING A S1P RECEPTOR AGONIST AND A SUGAR ALCOHOL | ⤷ Try a Trial |
| European Patent Office | 1613288 | COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT UN AGONISTE DES RECEPTEURS DE LA S1P ET UN ALCOOL DE SUCRE (SOLID PHARMACEUTICAL COMPOSITIONS COMPRISING A S1P RECEPTOR AGONIST AND A SUGAR ALCOHOL) | ⤷ Try a Trial |
| Taiwan | 201244711 | Formulations | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GILENYA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0627406 | 91832 | Luxembourg | ⤷ Try a Trial | 91832, EXPIRES: 20181018 |
| 1613288 | C 2011 005 | Romania | ⤷ Try a Trial | 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 |
| 0627406 | CA 2011 00015 | Denmark | ⤷ Try a Trial | |
| 1613288 | 399 | Finland | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Serving leading biopharmaceutical companies globally:
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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