FINGOLIMOD HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for fingolimod hydrochloride and what is the scope of patent protection?
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
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 | 15177166 | ⤷ Try a Trial | |
Morocco | 34981 | FORMULATIONS COMPRENANT 2-AMINO-2-2-4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL | ⤷ Try a Trial |
Japan | 6019101 | ⤷ Try a Trial | |
Chile | 2012000766 | Combinación farmacéutica que contiene fingolimod o un derivado de fosfato del mismo y un segundo fármaco; kit que contiene la combinación; y uso de fingolimod para el tratamiento de una enfermedad inflamatoria o autoinmune tal como esclerosis múltiple. | ⤷ Try a Trial |
Cyprus | 1118423 | ⤷ Try a Trial | |
Russian Federation | 2012117561 | СПОСОБ И СИСТЕМА ДОСТУПА К ДАННЫМ О ПАЦИЕНТАХ | ⤷ 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 | PA2011010,C1613288 | Lithuania | ⤷ Try a Trial | 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 | 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 | C20110013 00043 | Estonia | ⤷ Try a Trial | PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011 |
1613288 | 28/2011 | Austria | ⤷ Try a Trial | PRODUCT NAME: FINGOLIMODHYDROCHLORID; REGISTRATION NO/DATE: EU/1/11/677-001-004 20110317 |
1613288 | CA 2011 00023 | Denmark | ⤷ Try a Trial | |
1613288 | CR 2011 00023 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FINGOLIMOD, HERUNDER FINGOLIMOD SOM HYDROCHLORID; REG. NO/DATE: EU/1/11/677/001-004 20110317 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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