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FDA Orange Book · active-ingredient family

Simvastatin

Simvastatin is approved as 3 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FLOLIPID · NDA 206679

3

Brand (NDA)

16

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · suspension, tablet, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
FLOLIPIDRLD×2SALERNO PHARMSNDA 206679—Apr 21, 2016
SIMVASTATINRLD×4SYNTHON PHARMSNDA 021961—Oct 09, 2007
ZOCORRLD×5ORGANONNDA 019766ABDec 23, 1991

Generic (ANDA) products (16)

ProductApplicantApplicationTEApproved
SIMVASTATIN×5INVAGEN PHARMSANDA 206557ABOct 27, 2025
SIMVASTATIN×4YILINGANDA 211394ABNov 27, 2024
SIMVASTATIN×5HETERO LABS LTD IIIANDA 200895ABNov 25, 2014
SIMVASTATIN×5ACCORD HLTHCAREANDA 078155ABApr 05, 2013
SIMVASTATIN×5MICRO LABSANDA 090383ABSep 16, 2011
SIMVASTATIN×5OXFORD PHARMSANDA 078735ABAug 30, 2010
SIMVASTATIN×5PHARMOBEDIENTANDA 090868—Jun 08, 2010
SIMVASTATIN×5LUPINANDA 078103ABApr 14, 2009
SIMVASTATIN×5RISINGANDA 077752ABJan 23, 2008
SIMVASTATIN×5AUROBINDO PHARMAANDA 077691ABDec 20, 2006
SIMVASTATIN×5BIOCON PHARMAANDA 078034ABDec 20, 2006
SIMVASTATIN×5CHARTWELL RXANDA 077766—Dec 20, 2006
SIMVASTATIN×5SUN PHARM INDS LTDANDA 076285—Dec 20, 2006
SIMVASTATIN×5WATSON LABS TEVAANDA 076685—Dec 20, 2006
SIMVASTATIN×5ZYDUS PHARMS USAANDA 077837ABDec 20, 2006
SIMVASTATIN×5IVAX SUB TEVA PHARMSANDA 076052—Jun 23, 2006

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10300041Apr 26, 2027in 10 mo
Product
9597289Feb 23, 2030in 3 yr 9 mo
Product

Simvastatin — frequently asked questions

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

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