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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Colorcon
AstraZeneca
Johnson and Johnson
Moodys

Last Updated: November 27, 2021

DrugPatentWatch Database Preview

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, Biocon Ltd, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd V, Mylan, Strides Pharma, Sun Pharm, Teva Pharms Usa, Zydus Pharms, and Novartis, and is included in thirteen 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 thirty-one patent family members in fifty countries.

There are twenty-one drug master file entries for fingolimod hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for fingolimod hydrochloride

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

SponsorPhase
The Affiliated Hospital of Xuzhou Medical UniversityN/A
Ning Wang, MD., PhD.Phase 2
Tammie L. S. Benzinger, MD, PhD

See all fingolimod hydrochloride clinical trials

Generic filers with tentative approvals for FINGOLIMOD HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it FreeEQ 0.5MG BASECAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fingolimod hydrochloride
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 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
Hetero Labs Ltd V FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207933-001 May 18, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Strides Pharma FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207971-001 Jun 29, 2020 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Dr Reddys FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208000-001 Mar 5, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Biocon Ltd FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 207979-001 Dec 4, 2019 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan FINGOLIMOD HYDROCHLORIDE fingolimod hydrochloride CAPSULE;ORAL 208005-001 Jan 19, 2021 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 ⤷  Try it Free ⤷  Try it Free
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 ⤷  Try it Free ⤷  Try it Free
>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 C20110013 00043 Estonia ⤷  Try it Free PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
1613288 CA 2011 00023 Denmark ⤷  Try it Free
1613288 399 Finland ⤷  Try it Free
1613288 2011/027 Ireland ⤷  Try it Free 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
0627406 2011020 Ireland ⤷  Try it Free 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 it Free PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
1613288 PA2011010 Lithuania ⤷  Try it Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Colorcon
AstraZeneca
Johnson and Johnson
Moodys

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