Assyro AI

FDA Orange Book · active-ingredient family

Leucovorin calcium

Leucovorin calcium is approved as 4 brand and 51 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VYKOURA · NDA 220406

4

Brand (NDA)

51

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · for solution, injectable, solution, tablet

ProductApplicantApplicationTEApproved
VYKOURARLD×3AVYXA HOLDINGSNDA 220406—Feb 03, 2026
WELLCOVORINRLD×2GLAXOSMITHKLINENDA 018342—Jul 08, 1983
LEUCOVORIN CALCIUMRLD×5HOSPIRANDA 008107—Approved Prior to Jan 1, 1982
LEUCOVORIN CALCIUMXANODYNE PHARMNDA 018459—Jan 30, 1986

Generic (ANDA) products (51)

ProductApplicantApplicationTEApproved
LEUCOVORIN CALCIUMGLANDANDA 218200APNov 12, 2025
LEUCOVORIN CALCIUM×5MEITHEALANDA 216590APJul 19, 2023
LEUCOVORIN CALCIUM×5HAINAN POLYANDA 217021APJul 10, 2023
LEUCOVORIN CALCIUM×4LEADINGANDA 213929ABOct 22, 2020
LEUCOVORIN CALCIUM×4INGENUS PHARMS LLCANDA 211132ABJul 30, 2020
LEUCOVORIN CALCIUMINGENUS PHARMS LLCANDA 210917—Nov 23, 2018
LEUCOVORIN CALCIUMFRESENIUS KABI USAANDA 207226—Jul 27, 2018
LEUCOVORIN CALCIUMFRESENIUS KABI USAANDA 207241—Mar 14, 2018
LEUCOVORIN CALCIUM PRESERVATIVE FREESAGENT PHARMS INCANDA 209110APOct 26, 2017
LEUCOVORIN CALCIUM PRESERVATIVE FREE×3MYLAN LABS LTDANDA 203800APMay 19, 2017
LEUCOVORIN CALCIUM PRESERVATIVE FREE×3SAGENT PHARMSANDA 200753APSep 06, 2012
LEUCOVORIN CALCIUM PRESERVATIVE FREESAGENT PHARMSANDA 200855APSep 06, 2012
LEUCOVORIN CALCIUM PRESERVATIVE FREEAM REGENTANDA 040338—Jan 31, 2001
LEUCOVORIN CALCIUM PRESERVATIVE FREE×2HIKMAANDA 040347—Apr 25, 2000
LEUCOVORIN CALCIUM PRESERVATIVE FREEHIKMAANDA 040335APApr 20, 2000
LEUCOVORIN CALCIUMPHARMACHEMIEANDA 040262—Dec 15, 1999
LEUCOVORIN CALCIUM PRESERVATIVE FREETEVA PARENTERALANDA 040332—Jun 28, 1999
LEUCOVORIN CALCIUMANI PHARMSANDA 075327—Mar 24, 1999
LEUCOVORIN CALCIUM PRESERVATIVE FREEFRESENIUS KABI USAANDA 040258APFeb 26, 1999
LEUCOVORIN CALCIUM PRESERVATIVE FREEFRESENIUS KABI USAANDA 040286APFeb 26, 1999
LEUCOVORIN CALCIUM×4EPIC PHARMA LLCANDA 074544ABAug 28, 1997
LEUCOVORIN CALCIUM PRESERVATIVE FREE×2HOSPIRAANDA 040147—Jun 25, 1997
LEUCOVORIN CALCIUMTEVA PHARMS USAANDA 040174—Jun 12, 1997
LEUCOVORIN CALCIUMPHARMACHEMIE USAANDA 089628—Apr 17, 1997
LEUCOVORIN CALCIUMPHARMACHEMIE USAANDA 089915—Apr 17, 1997
LEUCOVORIN CALCIUMPHARMACHEMIEANDA 073099—Mar 28, 1997
LEUCOVORIN CALCIUMPHARMACHEMIEANDA 073101—Mar 28, 1997
LEUCOVORIN CALCIUM PRESERVATIVE FREEHIKMAANDA 040056APMay 23, 1995
LEUCOVORIN CALCIUMELKINS SINNANDA 081224—Jun 03, 1994
LEUCOVORIN CALCIUMTEVA PARENTERALANDA 081278—Sep 28, 1993
LEUCOVORIN CALCIUMTEVA PHARMS USAANDA 081277—Sep 28, 1993
LEUCOVORIN CALCIUMHIKMAANDA 072733ABFeb 22, 1993
LEUCOVORIN CALCIUMHIKMAANDA 072734ABFeb 22, 1993
LEUCOVORIN CALCIUMHIKMAANDA 072735ABFeb 22, 1993
LEUCOVORIN CALCIUMHIKMAANDA 072736ABFeb 22, 1993
WELLCOVORINGLAXOSMITHKLINEANDA 089833—Jan 23, 1989
WELLCOVORINGLAXOSMITHKLINEANDA 089465—Jan 23, 1989
WELLCOVORINGLAXOSMITHKLINEANDA 089834—Jan 23, 1989
LEUCOVORIN CALCIUMABICANDA 089353—Jun 01, 1988
LEUCOVORIN CALCIUMABICANDA 089352—Jun 01, 1988
LEUCOVORIN CALCIUMHIKMAANDA 089717APMar 28, 1988
LEUCOVORIN CALCIUMXANODYNE PHARMANDA 071962—Nov 19, 1987
LEUCOVORIN CALCIUMPAR PHARMANDA 071600—Oct 14, 1987
LEUCOVORIN CALCIUMPAR PHARMANDA 071598—Oct 14, 1987
LEUCOVORIN CALCIUMBARRANDA 071198ABSep 24, 1987
LEUCOVORIN CALCIUMBARRANDA 071199ABSep 24, 1987
LEUCOVORIN CALCIUMHIKMAANDA 089384APSep 14, 1987
LEUCOVORIN CALCIUMXANODYNE PHARMANDA 071104—Mar 04, 1987
LEUCOVORIN CALCIUMELKINS SINNANDA 070480—Jan 02, 1987
LEUCOVORIN CALCIUMABRAXIS PHARMANDA 088939—Dec 01, 1986
WELLCOVORIN×2GLAXOSMITHKLINEANDA 087439—Oct 19, 1982

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12564592Dec 23, 2044in 18 yr 9 mo
Product

Leucovorin calcium — 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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