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Last Updated: August 6, 2020

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RILUZOLE - Generic Drug Details

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What are the generic drug sources for riluzole and what is the scope of freedom to operate?

Riluzole is the generic ingredient in four branded drugs marketed by Aquestive Therap, Italfarmaco Spa, Covis Pharma Bv, Alkem Labs Ltd, Apotex Corp, Daito Pharms Co Ltd, Glenmark Pharms Ltd, Impax Labs, Kenton, Mylan Pharms Inc, and Sun Pharm Inds Ltd, and is included in eleven NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Riluzole has one hundred and eighty-six patent family members in twenty-eight countries.

There are nine drug master file entries for riluzole. Ten suppliers are listed for this compound.

Drug Prices for RILUZOLE

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Recent Clinical Trials for RILUZOLE

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

SponsorPhase
Omar JawdatPhase 1
Rare Diseases Clinical Research NetworkPhase 1
Terra Biological LLCPhase 1

See all RILUZOLE clinical trials

Pharmacology for RILUZOLE
Drug ClassBenzothiazole
Medical Subject Heading (MeSH) Categories for RILUZOLE

US Patents and Regulatory Information for RILUZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kenton RILUZOLE riluzole TABLET;ORAL 206045-001 Dec 9, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc RILUZOLE riluzole TABLET;ORAL 203042-001 Jul 1, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Aquestive Therap EXSERVAN riluzole FILM;ORAL 212640-001 Nov 22, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glenmark Pharms Ltd RILUZOLE riluzole TABLET;ORAL 091394-001 Jun 18, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Italfarmaco Spa TIGLUTIK KIT riluzole SUSPENSION;ORAL 209080-001 Sep 5, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharm Inds Ltd RILUZOLE riluzole TABLET;ORAL 091417-001 Jun 18, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Corp RILUZOLE riluzole TABLET;ORAL 091300-001 Jun 18, 2013 AB RX No No   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

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