FDA Orange Book · active-ingredient family
Leucovorin calcium
Leucovorin calcium: 4 brands, 51 generics; first approved Oct 19, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 51 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
51
Listed patents
1
Next patent expiry
Dec 23, 2044
in 18 yr 6 mo
Brand (NDA) products
Originator applications
- AVYXA HOLDINGSNDA 22040620263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/5ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx — EQ 350MG BASE/35ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx — EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx — - LEUCOVORIN CALCIUMRLDHOSPIRANDA 00810719875 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/ML (EQ 3MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 60MG BASE/VIAL FOR SOLUTION ORAL Discontinued — EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 350MG BASE/VIAL INJECTABLE INJECTION Discontinued — - WELLCOVORINRLDGLAXOSMITHKLINENDA 01834219832 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — EQ 25MG BASE TABLET ORAL Discontinued — - LEUCOVORIN CALCIUMXANODYNE PHARMNDA 0184591986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued —
Generic (ANDA) products (51)
Abbreviated applications
- LEUCOVORIN CALCIUMGLANDANDA 2182002025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 350MG BASE/VIAL INJECTABLE INJECTION Rx AP - LEUCOVORIN CALCIUMMEITHEALANDA 21659020235 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 350MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - LEUCOVORIN CALCIUMHAINAN POLYANDA 21702120235 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 350MG BASE/VIAL INJECTABLE INJECTION Rx AP - LEUCOVORIN CALCIUMLEADINGANDA 21392920204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 15MG BASE TABLET ORAL Rx AB EQ 25MG BASE TABLET ORAL Rx AB - LEUCOVORIN CALCIUMINGENUS PHARMS LLCANDA 21113220204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 15MG BASE TABLET ORAL Rx AB EQ 25MG BASE TABLET ORAL Rx AB - LEUCOVORIN CALCIUMINGENUS PHARMS LLCANDA 2109172018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — - LEUCOVORIN CALCIUMRSFRESENIUS KABI USAANDA 2072262018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx — - LEUCOVORIN CALCIUMRSFRESENIUS KABI USAANDA 2072412018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/10ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Rx — - SAGENT PHARMS INCANDA 2091102017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - MYLAN LABS LTDANDA 20380020173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 350MG BASE/VIAL INJECTABLE INJECTION Rx AP - SAGENT PHARMSANDA 20075320123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP - SAGENT PHARMSANDA 2008552012
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 350MG BASE/VIAL INJECTABLE INJECTION Rx AP - AM REGENTANDA 0403382001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HIKMAANDA 04034720002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE/30ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — - HIKMAANDA 0403352000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 350MG BASE/VIAL INJECTABLE INJECTION Rx AP - LEUCOVORIN CALCIUMPHARMACHEMIEANDA 0402621999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 350MG BASE/VIAL INJECTABLE INJECTION Discontinued — - TEVA PARENTERALANDA 0403321999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/50ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — - LEUCOVORIN CALCIUMANI PHARMSANDA 0753271999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15MG BASE TABLET ORAL Discontinued — - FRESENIUS KABI USAANDA 0402581999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP - FRESENIUS KABI USAANDA 0402861999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - LEUCOVORIN CALCIUMEPIC PHARMA LLCANDA 07454419974 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB EQ 25MG BASE TABLET ORAL Rx AB EQ 10MG BASE TABLET ORAL Rx AB EQ 15MG BASE TABLET ORAL Rx AB - HOSPIRAANDA 04014719972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/10ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — - LEUCOVORIN CALCIUMTEVA PHARMS USAANDA 0401741997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 350MG BASE/VIAL INJECTABLE INJECTION Discontinued — - LEUCOVORIN CALCIUMPHARMACHEMIE USAANDA 0896281997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - LEUCOVORIN CALCIUMPHARMACHEMIE USAANDA 0899151997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - LEUCOVORIN CALCIUMPHARMACHEMIEANDA 0730991997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — - LEUCOVORIN CALCIUMPHARMACHEMIEANDA 0731011997
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — - HIKMAANDA 0400561995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP - LEUCOVORIN CALCIUMELKINS SINNANDA 0812241994
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - LEUCOVORIN CALCIUMTEVA PARENTERALANDA 0812781993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - LEUCOVORIN CALCIUMTEVA PHARMS USAANDA 0812771993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - LEUCOVORIN CALCIUMHIKMAANDA 0727331993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB - LEUCOVORIN CALCIUMHIKMAANDA 0727341993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB - LEUCOVORIN CALCIUMHIKMAANDA 0727351993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15MG BASE TABLET ORAL Rx AB - LEUCOVORIN CALCIUMHIKMAANDA 0727361993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB - GLAXOSMITHKLINEANDA 0898331989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE/VIAL INJECTABLE INJECTION Discontinued — - GLAXOSMITHKLINEANDA 0894651989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - GLAXOSMITHKLINEANDA 0898341989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Discontinued — - LEUCOVORIN CALCIUMABICANDA 0893531988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - LEUCOVORIN CALCIUMABICANDA 0893521988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/ML (EQ 3MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — - LEUCOVORIN CALCIUMRSHIKMAANDA 0897171988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE/VIAL INJECTABLE INJECTION Rx AP - LEUCOVORIN CALCIUMXANODYNE PHARMANDA 0719621987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued — - LEUCOVORIN CALCIUMPAR PHARMANDA 0716001987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Discontinued — - LEUCOVORIN CALCIUMPAR PHARMANDA 0715981987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — - LEUCOVORIN CALCIUMBARRANDA 0711981987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE TABLET ORAL Rx AB - LEUCOVORIN CALCIUMBARRANDA 0711991987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB - LEUCOVORIN CALCIUMRSHIKMAANDA 0893841987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Rx AP - LEUCOVORIN CALCIUMXANODYNE PHARMANDA 0711041987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15MG BASE TABLET ORAL Discontinued — - LEUCOVORIN CALCIUMELKINS SINNANDA 0704801987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - LEUCOVORIN CALCIUMABRAXIS PHARMANDA 0889391986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - GLAXOSMITHKLINEANDA 08743919822 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML (EQ 5MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued — EQ 25MG BASE/5ML (EQ 5MG BASE/ML) SOLUTION INTRAMUSCULAR, INTRAVENOUS Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12564592 | in 18 yr 6 mo | Product |
Approval history
FDA approval span
First approval
44 yr 7 mo ago
Most recent approval
8 mo ago
Approvals span 1982–2026 across 55 FDA applications.
Brand (NDA) 47%
Generic (ANDA) 5193%
Leucovorin calcium: 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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- 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.
