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Last Updated: August 13, 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

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
Aquestive Therap EXSERVAN riluzole FILM;ORAL 212640-001 Nov 22, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Daito Pharms Co Ltd RILUZOLE riluzole TABLET;ORAL 204430-001 Oct 16, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Covis Pharma Bv RILUTEK riluzole TABLET;ORAL 020599-001 Dec 12, 1995 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glenmark Pharms Ltd RILUZOLE riluzole TABLET;ORAL 091394-001 Jun 18, 2013 AB RX No No   Start Trial   Start Trial   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
Impax Labs RILUZOLE riluzole TABLET;ORAL 076173-001 Jan 29, 2003 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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Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.