FDA Orange Book · active-ingredient family
Levetiracetam
Levetiracetam: 7 brands, 106 generics; first approved Nov 30, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 106 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
7
Generics (ANDA)
106
Listed patents
11
Next patent expiry
Feb 22, 2026
7 mo ago
Brand (NDA) products
Originator applications
- ELEPSIA XRRLDTRIPOINTNDA 20441720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — 1.5GM TABLET, EXTENDED RELEASE ORAL Discontinued — - SPRITAMRLDAPRECIA PHARMSNDA 20795820154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET, FOR SUSPENSION ORAL Rx — 500MG TABLET, FOR SUSPENSION ORAL Rx — 750MG TABLET, FOR SUSPENSION ORAL Discontinued — 1GM TABLET, FOR SUSPENSION ORAL Discontinued — - HQ SPCLT PHARMANDA 20254320114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/100ML (5MG/ML) INJECTABLE INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 1.5GM/100ML (15MG/ML) INJECTABLE INTRAVENOUS Rx AP 250MG/50ML (5MG/ML) INJECTABLE INTRAVENOUS Discontinued — - KEPPRA XRRLDUCB INCNDA 02228520082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - UCB INCNDA 0218722006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - UCB INCNDA 02103520064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - UCB INCNDA 0215052003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA
Generic (ANDA) products (106)
Abbreviated applications
- LEVETIRACETAMBAXTER HLTHCARE CORPANDA 2084582026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - MYLAN LABS LTDANDA 21836420263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/100ML (5MG/ML) INJECTABLE INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 1.5GM/100ML (15MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMKNACKANDA 2154652025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Discontinued — - LEVETIRACETAMANDA REPOSITORYANDA 2180802025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - CAPLINANDA 21956220253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/100ML (5MG/ML) INJECTABLE INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 1.5GM/100ML (15MG/ML) INJECTABLE INTRAVENOUS Rx AP - B BRAUN MEDICALANDA 20970520243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/100ML (5MG/ML) INJECTABLE INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 1.5GM/100ML (15MG/ML) INJECTABLE INTRAVENOUS Rx AP - HIKMAANDA 21135620243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/100ML (5MG/ML) INJECTABLE INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 1.5GM/100ML (15MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMSTRIDES PHARMAANDA 2146732023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Discontinued — - BAXTER HLTHCARE CORPANDA 21705920233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/100ML (5MG/ML) INJECTABLE INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 1.5GM/100ML (15MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMGRANULESANDA 21787820234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - LEVETIRACETAMOVERSEASANDA 21268820232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET, EXTENDED RELEASE ORAL Rx AB 500MG TABLET, EXTENDED RELEASE ORAL Rx AB - FRESENIUS KABI USAANDA 20861920233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/100ML (5MG/ML) INJECTABLE INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 1.5GM/100ML (15MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMMSNANDA 2159802022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMMSNANDA 21481520224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMMSNANDA 2147572022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMALKEM LABS LTDANDA 21637520224 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMPRINSTON INCANDA 2094742022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMSCIEGEN PHARMSANDA 21506920214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - LEVETIRACETAMSCIEGEN PHARMSANDA 20513020202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - NEXUSANDA 21353220203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/100ML (5MG/ML) INJECTABLE INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 1.5GM/100ML (15MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMMICRO LABSANDA 2119542019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMEPIC PHARMA LLCANDA 2099342018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Discontinued — - LEVETIRACETAMHAINAN POLY PHARMANDA 2097812018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - GLANDANDA 20688020173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/100ML (5MG/ML) INJECTABLE INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 1.5GM/100ML (15MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMHISUN PHARM HANGZHOUANDA 20717520172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - EUGIA PHARMAANDA 20716020173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/100ML (5MG/ML) INJECTABLE INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) INJECTABLE INTRAVENOUS Rx AP 1.5GM/100ML (15MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMLOTUS PHARM CO LTDANDA 09090620164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - LEVETIRACETAMMYLAN LABS LTDANDA 2033082016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMAIPING PHARM INCANDA 20475420162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - LEVETIRACETAMLOTUS PHARM CO LTDANDA 20209520162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMJUBILANT GENERICSANDA 2068382016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Discontinued — - LEVETIRACETAMANDA REPOSITORYANDA 20451120162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - LEVETIRACETAMEUGIA PHARMAANDA 2043122016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMCHINA RESOURCESANDA 20510220152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - LEVETIRACETAMAUROBINDO PHARMA USAANDA 20047520153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMADAPTISANDA 20216720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMFRESENIUS KABI USAANDA 0908762015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMPHARM ASSOCANDA 2011572015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMPRINSTON INCANDA 20346820152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - LEVETIRACETAMAPOTEXANDA 2029582015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMSUN PHARMANDA 20305920132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMSAGENT PHARMSANDA 0916272013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMALEMBICANDA 2030672013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMHETERO LABS LTD IIIANDA 2030522013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMSANDOZANDA 09166820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMROUSES POINT PHARMSANDA 20252420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMPRINSTON INCANDA 20253320122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMTORRENT PHARMS LTDANDA 09133820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - LEVETIRACETAMPHARMADAXANDA 20146420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMQUAGENANDA 0900792012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMHOSPIRA INCANDA 2028692012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMHIKMAANDA 0906012012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Discontinued — - LEVETIRACETAMAM REGENTANDA 2021432012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Discontinued — - LEVETIRACETAMLUPIN LTDANDA 0908932011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Discontinued — - LEVETIRACETAMHIKMA FARMACEUTICAANDA 0909812011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMPH HEALTHANDA 09136020112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMACTAVIS ELIZABETHANDA 09155720112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMACTAVIS LABS FL INCANDA 09109320112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - LEVETIRACETAMAPOTEX INCANDA 09126120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - LEVETIRACETAMCHARTWELL RXANDA 09129120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMLUPIN LTDANDA 09139920112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Rx AB 750MG TABLET, EXTENDED RELEASE ORAL Rx AB - LEVETIRACETAMSUN PHARM INDUSTRIESANDA 09128520112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMTEVA PHARMSANDA 09143020112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET, EXTENDED RELEASE ORAL Discontinued — 750MG TABLET, EXTENDED RELEASE ORAL Discontinued — - LEVETIRACETAMMPP PHARMAANDA 09051120114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - LEVETIRACETAMXGEN PHARMSANDA 0914852011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Rx AP - LEVETIRACETAMAPOTEX INCANDA 0901872011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Discontinued — - LEVETIRACETAMCHARTWELL RXANDA 20129320114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMACCORD HLTHCAREANDA 09084320114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - LEVETIRACETAMZHEJIANG JINGXINANDA 09149120104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMHETERO LABS LTD IIIANDA 09051520104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMAJENAT PHARMSANDA 0904612010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMORBION PHARMSANDA 0904842010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - LEVETIRACETAMRISINGANDA 09076720104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMSUN PHARM INDS LTDANDA 0907542010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Discontinued — - LEVETIRACETAMFRESENIUS KABI USAANDA 0908132010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML (100MG/ML) INJECTABLE INTRAVENOUS Discontinued — - LEVETIRACETAMPHARMOBEDIENT CNSLTGANDA 0900282010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Discontinued — - LEVETIRACETAMTAROANDA 07896020104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — - LEVETIRACETAMMYLANANDA 0902612009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - LEVETIRACETAMAMNEAL PHARMSANDA 0909922009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMZYDUS PHARMS USA INCANDA 07891820092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMCHARTWELL MOLECULARANDA 0902632009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMOXFORD PHARMSANDA 07731920093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVETIRACETAMNOVAXANDA 07886920094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMACTAVIS LABS FL INCANDA 07740820093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — - LEVETIRACETAMTAROANDA 0787742009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMMYLANANDA 07873120094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - LEVETIRACETAMPRINSTON INCANDA 07810620094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMBIONPHARMAANDA 0791202009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMACTAVIS MID ATLANTICANDA 0789762009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMAUROBINDO PHARMAANDA 0790632009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Rx AA - LEVETIRACETAMSTRIDES PHARMAANDA 0785822009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Discontinued — - LEVETIRACETAMTOLMARANDA 0791072009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML SOLUTION ORAL Discontinued — - LEVETIRACETAMAUROBINDO PHARMAANDA 07899320094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMFOSUN PHARMAANDA 07732420094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - LEVETIRACETAMINGENUS PHARMS LLCANDA 07904220094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMINVAGEN PHARMSANDA 07823420093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — - LEVETIRACETAMLUPINANDA 0900252009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - LEVETIRACETAMLUPINANDA 07815420093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVETIRACETAMORBION PHARMSANDA 07852620093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVETIRACETAMSENORES PHARMSANDA 0789042009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - LEVETIRACETAMSENORES PHARMSANDA 07692020093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB - LEVETIRACETAMSTRIDES PHARMAANDA 07804220094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - LEVETIRACETAMTEVA PHARMSANDA 07810120094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — 1GM TABLET ORAL Discontinued — - LEVETIRACETAMTORRENT PHARMSANDA 07885820094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 1GM TABLET ORAL Rx AB - LEVETIRACETAMWATSON LABS INCANDA 07879720094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Discontinued — 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — 750MG TABLET ORAL Discontinued — - LEVETIRACETAMMYLANANDA 07691920083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG TABLET ORAL Discontinued — 500MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8535717 | 7 mo ago | Product | |
| 8425938 | 7 mo ago | Product | |
| 8163306 | in 1 yr | Product | |
| 8431156 | in 1 yr 2 mo | Product | |
| 8470367 | in 1 yr 2 mo | Product | |
| 7858122 | in 2 yr | Product | |
| 8802142 | in 4 yr 9 mo | Product | |
| 8802142*PED | in 5 yr 4 mo | ||
| 9339489 | in 7 yr 7 mo | ProductU-1850 | |
| 9669009 | in 7 yr 7 mo | U-1850 | |
| 11160786 | in 7 yr 7 mo | Product |
Approval history
FDA approval span
First approval
27 yr 2 mo ago
Most recent approval
1 mo ago
Approvals span 1999–2026 across 113 FDA applications.
Brand (NDA) 76%
Generic (ANDA) 10694%
Levetiracetam: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
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- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
