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Last Updated: August 12, 2020

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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 Biocon Ltd, Glenmark Pharms Ltd, Hec Pharm Co Ltd, Hetero Labs Ltd V, Strides Pharma, Sun Pharm, and Novartis, and is included in seven 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 eighteen patent family members in fifty countries.

There are twenty-one drug master file entries for fingolimod hydrochloride. Two suppliers are listed for this compound.

Recent Clinical Trials for FINGOLIMOD HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
First Affiliated Hospital of Fujian Medical UniversityPhase 2
Wake Forest University Health SciencesEarly Phase 1
Mayo ClinicEarly Phase 1

See all FINGOLIMOD HYDROCHLORIDE clinical trials

Pharmacology for FINGOLIMOD HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for FINGOLIMOD HYDROCHLORIDE
Paragraph IV (Patent) Challenges for FINGOLIMOD HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
GILENYA CAPSULE;ORAL fingolimod hydrochloride 022527 2018-07-19
GILENYA CAPSULE;ORAL fingolimod hydrochloride 022527 2018-07-18
GILENYA CAPSULE;ORAL fingolimod hydrochloride 022527 2014-09-22

US Patents and Regulatory Information for FINGOLIMOD HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208014-001 Dec 4, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Biocon Ltd FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207979-001 Dec 4, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start 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 FINGOLIMOD HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FINGOLIMOD HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 CR 2011 00023 Denmark   Start Trial PRODUCT NAME: FINGOLIMOD, HERUNDER FINGOLIMOD SOM HYDROCHLORID; REG. NO/DATE: EU/1/11/677/001-004 20110317
1613288 C300497 Netherlands   Start Trial PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
0627406 C300488 Netherlands   Start Trial PRODUCT NAME: FINGOLIMOD, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
1613288 CA 2011 00023 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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