Fingolimod hydrochloride - Generic Drug Details
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What are the generic drug sources for fingolimod hydrochloride and what is the scope of freedom to operate?
Fingolimod hydrochloride
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Biocon Ltd, Bionpharma, Chartwell Rx, Dr Reddys, Ezra Ventures, Glenmark Pharms Ltd, Hec Pharm Co Ltd, Hetero Labs Ltd V, Mylan, Prinston Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, and Novartis, and is included in nineteen NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Fingolimod hydrochloride has two hundred and forty-six patent family members in fifty countries.
There are twenty drug master file entries for fingolimod hydrochloride. Nineteen suppliers are listed for this compound.
Summary for fingolimod hydrochloride
International Patents: | 246 |
US Patents: | 4 |
Tradenames: | 2 |
Applicants: | 18 |
NDAs: | 19 |
Drug Master File Entries: | 20 |
Finished Product Suppliers / Packagers: | 19 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 74 |
Patent Applications: | 829 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for fingolimod hydrochloride |
What excipients (inactive ingredients) are in fingolimod hydrochloride? | fingolimod hydrochloride excipients list |
DailyMed Link: | fingolimod hydrochloride at DailyMed |
Recent Clinical Trials for fingolimod hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The Methodist Hospital Research Institute | Phase 2 |
General Hospital of Shenyang Military Region | Phase 4 |
Hoffmann-La Roche | Phase 3 |
Pharmacology for fingolimod hydrochloride
Drug Class | Sphingosine 1-phosphate Receptor Modulator |
Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
Medical Subject Heading (MeSH) Categories for fingolimod hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for fingolimod hydrochloride
Paragraph IV (Patent) Challenges for FINGOLIMOD HYDROCHLORIDE
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 fingolimod hydrochloride
Expired US Patents for fingolimod hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | GILENYA | fingolimod hydrochloride | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fingolimod hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 3143990 | ⤷ Try a Trial | |
Colombia | 6771459 | Formulaciones que comprenden 2-amino-2-[2- (4-octil-fenil)-etil] -propano-1,3-diol | ⤷ Try a Trial |
Japan | 2021035955 | 多発性硬化症を処置するためのS1P受容体モジュレーター (S1P RECEPTOR MODULATORS FOR TREATING MULTIPLE SCLEROSIS) | ⤷ Try a Trial |
Japan | 2018172401 | S1P受容体モジュレーターの投与計画 (DOSAGE REGIMEN OF S1P RECEPTOR MODULATOR) | ⤷ Try a Trial |
Japan | 2013166761 | S1P RECEPTOR MODULATOR FOR TREATMENT OF MULTIPLE SCLEROSIS | ⤷ Try a Trial |
Morocco | 34981 | FORMULATIONS COMPRENANT 2-AMINO-2-2-4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL | ⤷ Try a Trial |
European Patent Office | 3061449 | POSOLOGIE D'UN AGONISTE DU RÉCEPTEUR S1P (DOSAGE REGIMEN OF AN S1P RECEPTOR MODULATOR) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fingolimod hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1613288 | 122011100047 | Germany | ⤷ Try a Trial | PRODUCT NAME: FINGOLIMOD ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON; NAT. REGISTRATION NO/DATE: FIRST REGISTRATION: EU EU/1/11/677/001-004 20110317EU/1/11/677/001 EU/1/11/677/002 EU/1/11/677/003 EU/1/11/677/004 20110317 |
1613288 | 2011/027 | Ireland | ⤷ Try a Trial | PRODUCT NAME: GILENYA-FINGOLIMOD; NAT REGISTRATION NO/DATE: EU/1/11/677/001 20110317; FIRST REGISTRATION NO/DATE: EU/1/11/677/002 17/03/2011 IRELAND EU/1/11/677/003 17/03/2011 IRELAND EU/1/11/677/004 20110317 |
1613288 | 107 5008-2011 | Slovakia | ⤷ Try a 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 |
0627406 | 2011020 | Ireland | ⤷ Try a Trial | 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 | 1190015-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317 |
1613288 | 91867 | Luxembourg | ⤷ Try a Trial | 91867, EXPIRES: 20260317 |
1613288 | C300497 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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