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FDA Orange Book · active-ingredient family

Cephalexin

Cephalexin is approved as 3 brand and 54 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:KEFLET · NDA 050440

3

Brand (NDA)

54

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, for suspension, tablet, tablet, for suspension

ProductApplicantApplicationTEApproved
KEFLETRLD×3LILLYNDA 050440—Feb 26, 1987
KEFLEXRLD×4PRAGMANDA 050405—Approved Prior to Jan 1, 1982
KEFLEXRLD×3PRAGMANDA 050406—Approved Prior to Jan 1, 1982

Generic (ANDA) products (54)

ProductApplicantApplicationTEApproved
CEPHALEXIN×2AUROBINDO PHARMAANDA 213568ABJun 09, 2026
CEPHALEXIN×2ALKEM LABS LTDANDA 218947ABSep 27, 2024
CEPHALEXIN×2AUROBINDO PHARMA LTDANDA 218817ABSep 27, 2024
CEPHALEXIN×2ALKEM LABS LTDANDA 210221ABMar 26, 2019
CEPHALEXIN×4ALKEM LABS LTDANDA 090836ABDec 20, 2010
CEPHALEXIN×2HIKMA PHARMSANDA 065444—Aug 28, 2009
CEPHALEXIN×2YUNG SHIN PHARMANDA 065336ABJul 25, 2007
CEPHALEXIN×2CHARTWELL RXANDA 065326—Jul 10, 2006
CEPHALEXIN×2HIKMAANDA 065215—Jan 24, 2006
CEPHALEXIN×2LUPINANDA 065229ABNov 25, 2005
CEPHALEXIN×3AUROBINDO PHARMAANDA 065253ABNov 16, 2005
CEPHALEXIN×2LUPINANDA 065234ABAug 17, 2005
CEPHALEXIN×2ANDA REPOSITORYANDA 065248ABJun 28, 2005
CEPHALEXIN×2CHARTWELL RXANDA 065152ABFeb 24, 2005
PANIXINE DISPERDOSE×2RANBAXY LABS LTDANDA 065100—Sep 11, 2003
CEPHALEXIN×2SUN PHARM INDS LTDANDA 065081—Jul 27, 2001
CEPHALEXIN×2SUN PHARM INDS LTDANDA 065007—Sep 16, 1999
CEPHALEXIN×2APOTHECONANDA 063186—Dec 30, 1994
CEPHALEXINAPOTHECONANDA 062986—Apr 18, 1991
CEPHALEXIN×2APOTHECONANDA 063063—Sep 29, 1989
CEPHALEXINAPOTHECONANDA 062987—Jul 25, 1989
CEPHALEXIN×2TEVAANDA 063024—Jan 12, 1989
CEPHALEXINAPOTHECONANDA 062974—Nov 23, 1988
CEPHALEXINAPOTHECONANDA 062973—Nov 08, 1988
CEPHALEXIN×3VITARINEANDA 062863—Aug 11, 1988
CEPHALEXIN×2AJENAT PHARMSANDA 062713ABJul 15, 1988
CEPHALEXINYOSHITOMIANDA 062871—Jul 05, 1988
CEPHALEXINYOSHITOMIANDA 062872—Jun 20, 1988
CEPHALEXINTEVAANDA 062873—May 23, 1988
CEPHALEXINTEVAANDA 062867—Apr 15, 1988
CEPHALEXINSTEVENS JANDA 062870—Mar 17, 1988
CEPHALEXINSTEVENS JANDA 062869—Mar 17, 1988
CEPHALEXINTEVAANDA 062821—Feb 05, 1988
CEPHALEXINTEVAANDA 062823—Feb 05, 1988
CEPHALEXINVITARINEANDA 062779—Dec 22, 1987
CEPHALEXINVITARINEANDA 062781—Dec 22, 1987
CEPHALEXINBARRANDA 062826—Aug 17, 1987
CEPHALEXINBARRANDA 062827—Aug 17, 1987
CEPHALEXINBARRANDA 062778—Aug 06, 1987
CEPHALEXINBARRANDA 062777—Aug 06, 1987
CEPHALEXINBARRANDA 062773—Jun 26, 1987
CEPHALEXINTEVAANDA 062767—Jun 16, 1987
CEPHALEXINTEVAANDA 062768—Jun 16, 1987
CEPHALEXIN×2SUN PHARM INDS (IN)ANDA 062791—Jun 11, 1987
CEPHALEXINTEVAANDA 062760—Apr 24, 1987
CEPHALEXINTEVAANDA 062761—Apr 24, 1987
CEPHALEXINBARRANDA 062775—Apr 22, 1987
CEPHALEXIN×2PUREPAC PHARMANDA 062809—Apr 22, 1987
CEPHALEXIN×2TEVAANDA 062702ABFeb 13, 1987
CEPHALEXIN×2TEVAANDA 062703ABFeb 13, 1987
KEFLET×2LILLYANDA 062745—Dec 01, 1986
CEPHALEXIN×2FACTA FARMAANDA 062118—Approved Prior to Jan 1, 1982
CEPHALEXIN×2IVAX SUB TEVA PHARMSANDA 061969—Approved Prior to Jan 1, 1982
CEPHALEXIN×3FACTA FARMAANDA 062117—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Cephalexin — frequently asked questions

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

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