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FDA Orange Book · active-ingredient family

Levetiracetam

Levetiracetam is approved as 7 brand and 105 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ELEPSIA XR · NDA 204417

7

Brand (NDA)

105

Generics (ANDA)

11

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution, tablet, tablet, extended release, tablet, for suspension

ProductApplicantApplicationTEApproved
ELEPSIA XRRLD×2TRIPOINTNDA 204417—Dec 20, 2018
SPRITAMRLD×4APRECIA PHARMSNDA 207958—Jul 31, 2015
LEVETIRACETAM IN SODIUM CHLORIDERLD×4HQ SPCLT PHARMANDA 202543APNov 09, 2011
KEPPRA XRRLD×2UCB INCNDA 022285ABSep 12, 2008
KEPPRARLDUCB INCNDA 021872APJul 31, 2006
KEPPRARLD×4UCB INCNDA 021035ABJan 06, 2006
KEPPRARLDUCB INCNDA 021505AAJul 15, 2003

Generic (ANDA) products (105)

ProductApplicantApplicationTEApproved
LEVETIRACETAM IN SODIUM CHLORIDE×3MYLAN LABS LTDANDA 218364APMay 08, 2026
LEVETIRACETAMKNACKANDA 215465—Dec 02, 2025
LEVETIRACETAMANDA REPOSITORYANDA 218080AANov 21, 2025
LEVETIRACETAM IN SODIUM CHLORIDE×3CAPLINANDA 219562APJan 16, 2025
LEVETIRACETAM IN SODIUM CHLORIDE×3B BRAUN MEDICALANDA 209705APFeb 27, 2024
LEVETIRACETAM IN SODIUM CHLORIDE×3HIKMAANDA 211356APFeb 12, 2024
LEVETIRACETAMSTRIDES PHARMAANDA 214673—Nov 20, 2023
LEVETIRACETAM IN SODIUM CHLORIDE×3BAXTER HLTHCARE CORPANDA 217059APOct 02, 2023
LEVETIRACETAM×4GRANULESANDA 217878—Jun 13, 2023
LEVETIRACETAM×2OVERSEASANDA 212688ABMay 05, 2023
LEVETIRACETAM IN SODIUM CHLORIDE×3FRESENIUS KABI USAANDA 208619APJan 31, 2023
LEVETIRACETAMMSNANDA 215980APNov 15, 2022
LEVETIRACETAM×4MSNANDA 214815ABOct 07, 2022
LEVETIRACETAMMSNANDA 214757AAJul 15, 2022
LEVETIRACETAM×4ALKEM LABS LTDANDA 216375ABMay 27, 2022
LEVETIRACETAMPRINSTON INCANDA 209474APMar 28, 2022
LEVETIRACETAM×4SCIEGEN PHARMSANDA 215069ABJun 11, 2021
LEVETIRACETAM×2SCIEGEN PHARMSANDA 205130ABNov 27, 2020
LEVETIRACETAM IN SODIUM CHLORIDE×3NEXUSANDA 213532APJul 06, 2020
LEVETIRACETAMMICRO LABSANDA 211954APAug 09, 2019
LEVETIRACETAMEPIC PHARMA LLCANDA 209934—May 04, 2018
LEVETIRACETAMHAINAN POLY PHARMANDA 209781APMar 20, 2018
LEVETIRACETAM IN SODIUM CHLORIDE×3GLANDANDA 206880APOct 25, 2017
LEVETIRACETAM×2HISUN PHARM HANGZHOUANDA 207175ABSep 28, 2017
LEVETIRACETAM IN SODIUM CHLORIDE×3EUGIA PHARMAANDA 207160APJan 04, 2017
LEVETIRACETAM×4LOTUS PHARM CO LTDANDA 090906—Oct 31, 2016
LEVETIRACETAMMYLAN LABS LTDANDA 203308APSep 16, 2016
LEVETIRACETAM×2AIPING PHARM INCANDA 204754ABAug 26, 2016
LEVETIRACETAM×2LOTUS PHARM CO LTDANDA 202095—Jun 06, 2016
LEVETIRACETAMJUBILANT GENERICSANDA 206838—Jun 02, 2016
LEVETIRACETAM×2ANDA REPOSITORYANDA 204511ABFeb 23, 2016
LEVETIRACETAMEUGIA PHARMAANDA 204312APFeb 01, 2016
LEVETIRACETAM×2CHINA RESOURCESANDA 205102—Dec 16, 2015
LEVETIRACETAM×3AUROBINDO PHARMA USAANDA 200475—Dec 07, 2015
LEVETIRACETAM×2ADAPTISANDA 202167—Sep 04, 2015
LEVETIRACETAMFRESENIUS KABI USAANDA 090876APAug 13, 2015
LEVETIRACETAMPHARM ASSOCANDA 201157AAJun 04, 2015
LEVETIRACETAM×2PRINSTON INCANDA 203468ABMay 21, 2015
LEVETIRACETAMAPOTEXANDA 202958—Feb 25, 2015
LEVETIRACETAM×2SUN PHARMANDA 203059—Sep 09, 2013
LEVETIRACETAMSAGENT PHARMSANDA 091627APJun 26, 2013
LEVETIRACETAMALEMBICANDA 203067AAMay 09, 2013
LEVETIRACETAMHETERO LABS LTD IIIANDA 203052AAFeb 28, 2013
LEVETIRACETAM×2SANDOZANDA 091668—Nov 01, 2012
LEVETIRACETAM×2ROUSES POINT PHARMSANDA 202524—Aug 27, 2012
LEVETIRACETAM×2PRINSTON INCANDA 202533—Jul 20, 2012
LEVETIRACETAM×2TORRENT PHARMS LTDANDA 091338ABMay 29, 2012
LEVETIRACETAM×2PHARMADAXANDA 201464—May 25, 2012
LEVETIRACETAMQUAGENANDA 090079AAApr 11, 2012
LEVETIRACETAMHOSPIRA INCANDA 202869APApr 06, 2012
LEVETIRACETAMHIKMAANDA 090601—Feb 28, 2012
LEVETIRACETAMAM REGENTANDA 202143—Jan 31, 2012
LEVETIRACETAMLUPIN LTDANDA 090893—Oct 17, 2011
LEVETIRACETAMHIKMA FARMACEUTICAANDA 090981APOct 13, 2011
LEVETIRACETAM×2PH HEALTHANDA 091360—Oct 04, 2011
LEVETIRACETAM×2ACTAVIS ELIZABETHANDA 091557—Sep 12, 2011
LEVETIRACETAM×2ACTAVIS LABS FL INCANDA 091093ABSep 12, 2011
LEVETIRACETAM×2APOTEX INCANDA 091261ABSep 12, 2011
LEVETIRACETAM×2CHARTWELL RXANDA 091291—Sep 12, 2011
LEVETIRACETAM×2LUPIN LTDANDA 091399ABSep 12, 2011
LEVETIRACETAM×2SUN PHARM INDUSTRIESANDA 091285—Sep 12, 2011
LEVETIRACETAM×2TEVA PHARMSANDA 091430—Sep 12, 2011
LEVETIRACETAM×4MPP PHARMAANDA 090511—Aug 18, 2011
LEVETIRACETAMXGEN PHARMSANDA 091485APAug 05, 2011
LEVETIRACETAMAPOTEX INCANDA 090187—Aug 05, 2011
LEVETIRACETAM×4CHARTWELL RXANDA 201293ABJun 14, 2011
LEVETIRACETAM×4ACCORD HLTHCAREANDA 090843—Feb 14, 2011
LEVETIRACETAM×4ZHEJIANG JINGXINANDA 091491ABDec 14, 2010
LEVETIRACETAM×4HETERO LABS LTD IIIANDA 090515ABOct 08, 2010
LEVETIRACETAMAJENAT PHARMSANDA 090461AASep 30, 2010
LEVETIRACETAMORBION PHARMSANDA 090484ABAug 05, 2010
LEVETIRACETAM×4RISINGANDA 090767ABJul 28, 2010
LEVETIRACETAMSUN PHARM INDS LTDANDA 090754—Jun 16, 2010
LEVETIRACETAMFRESENIUS KABI USAANDA 090813—May 26, 2010
LEVETIRACETAMPHARMOBEDIENT CNSLTGANDA 090028—Mar 03, 2010
LEVETIRACETAM×4TAROANDA 078960—Feb 01, 2010
LEVETIRACETAMMYLANANDA 090261ABDec 08, 2009
LEVETIRACETAMAMNEAL PHARMSANDA 090992AAOct 27, 2009
LEVETIRACETAM×2ZYDUS PHARMS USA INCANDA 078918ABApr 29, 2009
LEVETIRACETAMCHARTWELL MOLECULARANDA 090263AAApr 03, 2009
LEVETIRACETAM×3OXFORD PHARMSANDA 077319ABMar 20, 2009
LEVETIRACETAM×4VIWIT PHARMANDA 078869ABMar 13, 2009
LEVETIRACETAM×3ACTAVIS LABS FL INCANDA 077408—Mar 02, 2009
LEVETIRACETAMTAROANDA 078774AAFeb 10, 2009
LEVETIRACETAM×4MYLANANDA 078731—Feb 10, 2009
LEVETIRACETAM×4PRINSTON INCANDA 078106ABFeb 10, 2009
LEVETIRACETAMBIONPHARMAANDA 079120AAJan 16, 2009
LEVETIRACETAMACTAVIS MID ATLANTICANDA 078976AAJan 15, 2009
LEVETIRACETAMAUROBINDO PHARMAANDA 079063AAJan 15, 2009
LEVETIRACETAMSTRIDES PHARMAANDA 078582AAJan 15, 2009
LEVETIRACETAMTOLMARANDA 079107—Jan 15, 2009
LEVETIRACETAM×4AUROBINDO PHARMAANDA 078993ABJan 15, 2009
LEVETIRACETAM×4FOSUN PHARMAANDA 077324—Jan 15, 2009
LEVETIRACETAM×4INGENUS PHARMS LLCANDA 079042ABJan 15, 2009
LEVETIRACETAM×3INVAGEN PHARMSANDA 078234—Jan 15, 2009
LEVETIRACETAMLUPINANDA 090025ABJan 15, 2009
LEVETIRACETAM×3LUPINANDA 078154ABJan 15, 2009
LEVETIRACETAM×3ORBION PHARMSANDA 078526ABJan 15, 2009
LEVETIRACETAMSENORES PHARMSANDA 078904ABJan 15, 2009
LEVETIRACETAM×3SENORES PHARMSANDA 076920ABJan 15, 2009
LEVETIRACETAM×4STRIDES PHARMAANDA 078042—Jan 15, 2009
LEVETIRACETAM×4TEVA PHARMSANDA 078101—Jan 15, 2009
LEVETIRACETAM×4TORRENT PHARMSANDA 078858ABJan 15, 2009
LEVETIRACETAM×4WATSON LABS INCANDA 078797—Jan 15, 2009
LEVETIRACETAM×3MYLANANDA 076919—Nov 04, 2008

Listed patents (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8535717Feb 22, 20264 mo ago
Product
8425938Feb 22, 20264 mo ago
Product
8163306Sep 03, 2027in 1 yr 3 mo
Product
8431156Oct 31, 2027in 1 yr 5 mo
Product
8470367Oct 31, 2027in 1 yr 5 mo
Product
7858122Sep 17, 2028in 2 yr 3 mo
Product
8802142Jun 07, 2031in 5 yr
Product
8802142*PEDDec 07, 2031in 5 yr 7 mo
9339489Mar 14, 2034in 7 yr 10 mo
ProductU-1850
9669009Mar 14, 2034in 7 yr 10 mo
U-1850
11160786Mar 14, 2034in 7 yr 10 mo
Product

Levetiracetam — frequently asked questions

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

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