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FDA Orange Book · active-ingredient family

Riluzole

Riluzole is approved as 3 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:EXSERVAN · NDA 212640

3

Brand (NDA)

9

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · film, suspension, tablet

ProductApplicantApplicationTEApproved
EXSERVANRLDAQUESTIVENDA 212640—Nov 22, 2019
TIGLUTIK KITRLDITALFARMACO SANDA 209080ABSep 05, 2018
RILUTEKRLDAZURITYNDA 020599—Dec 12, 1995

Generic (ANDA) products (9)

ProductApplicantApplicationTEApproved
RILUZOLEALKEM LABS LTDANDA 216035ABAug 22, 2024
RILUZOLEKENTONANDA 206045ABDec 09, 2019
RILUZOLEDAITO PHARMS CO LTDANDA 204430—Oct 16, 2018
RILUZOLEALKEM LABS LTDANDA 204048ABMar 30, 2016
RILUZOLEPHARMOBEDIENTANDA 203042—Jul 01, 2013
RILUZOLEAPOTEX CORPANDA 091300—Jun 18, 2013
RILUZOLEGLENMARK PHARMS LTDANDA 091394ABJun 18, 2013
RILUZOLESUN PHARM INDS LTDANDA 091417—Jun 18, 2013
RILUZOLEIMPAX LABSANDA 076173ABJan 29, 2003

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8765150Mar 12, 2029in 2 yr 9 mo
ProductU-2401

Riluzole — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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