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FDA Orange Book · active-ingredient family

Methotrexate

Methotrexate: 5 brands, 0 generics; first approved Oct 11, 2013; on patent until Jan 24, 2026.

On patentHas discontinued products
Generic status & protection

Protected until Jan 24, 2026 (earliest listed patent expiry).

Earliest patent expiry
Brands (NDA)
5
Generics (ANDA)
0
Listed patents
19
Next patent expiry
Jan 24, 2026
9 mo ago

Brand (NDA) products

Originator applications
  • JYLAMVORLDRS
    NDA 2124792022
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2MG/MLSOLUTIONORALRx—
  • METHOTREXATERLD
    NDA 2141212020
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    5GM/50ML (100MG/ML)SOLUTIONINTRAVENOUSDiscontinued—
  • REDITREXRLD
    NDA 21073720198 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MG/0.3ML (7.5MG/0.3ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    10MG/0.4ML (10MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    12.5MG/0.5ML (12.5MG/0.5ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    15MG/0.6ML (15MG/0.6ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    17.5MG/0.7ML (17.5MG/0.7ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    20MG/0.8ML (20MG/0.8ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    22.5MG/ML (22.5MG/ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    25MG/1ML (25MG/1ML)SOLUTIONSUBCUTANEOUSDiscontinued—
  • OTREXUPRLD
    NDA 204824201414 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    10MG/0.4ML (10MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    15MG/0.4ML (15MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    20MG/0.4ML (20MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    25MG/0.4ML (25MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    7.5MG/0.4ML (7.5MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    12.5MG/0.4ML (12.5MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    17.5MG/0.4ML (17.5MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    22.5MG/0.4ML (22.5MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    10MG/0.4ML (10MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    15MG/0.6ML (15MG/0.6ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    17.5MG/0.7ML (17.5MG/0.7ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    20MG/0.8ML (20MG/0.8ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    22.5MG/0.9ML (22.5MG/0.9ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    25MG/ML (25MG/ML)SOLUTIONSUBCUTANEOUSDiscontinued—
  • RASUVORLDRS
    NDA 205776201410 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    7.5MG/0.15ML (7.5MG/0.15ML)SOLUTIONSUBCUTANEOUSRx—
    10MG/0.20ML (10MG/0.20ML)SOLUTIONSUBCUTANEOUSRx—
    12.5MG/0.25ML (12.5MG/0.25ML)SOLUTIONSUBCUTANEOUSRx—
    15MG/0.30ML (15MG/0.30ML)SOLUTIONSUBCUTANEOUSRx—
    17.5MG/0.35ML (17.5MG/0.35ML)SOLUTIONSUBCUTANEOUSRx—
    20MG/0.4ML (20MG/0.4ML)SOLUTIONSUBCUTANEOUSRx—
    22.5MG/0.45ML (22.5MG/0.45ML)SOLUTIONSUBCUTANEOUSRx—
    25MG/0.5ML (25MG/0.5ML)SOLUTIONSUBCUTANEOUSRx—
    27.5MG/0.55ML (27.5MG/0.55ML)SOLUTIONSUBCUTANEOUSDiscontinued—
    30MG/0.6ML (30MG/0.6ML)SOLUTIONSUBCUTANEOUSRx—

Patent & exclusivity timeline

Protection horizon
20262027202820292030203120322033203420352036TodayPatent 9629959: 2026-01-24Patent 9629959Patent 8562564: 2026-01-24Patent 8562564Patent 11446441: 2026-01-24Patent 11446441Patent 9533102: 2026-01-24Patent 9533102Patent 8021335: 2026-10-04Patent 8021335Patent 11684723: 2029-03-10Patent 11684723Patent 9867949: 2029-03-10Patent 9867949Patent 10709844: 2029-03-10Patent 10709844Patent 8664231: 2029-06-01Patent 8664231Patent 8480631: 2030-03-19Patent 8480631Patent 8945063: 2030-03-19Patent 8945063Patent 9421333: 2030-03-19Patent 9421333Patent 8579865: 2030-03-19Patent 8579865Patent 12357642: 2030-03-19Patent 12357642Patent 11497753: 2030-03-19Patent 11497753Patent 8814834: 2031-05-27Patent 8814834Patent 11771701: 2034-10-29Patent 11771701Patent 12605385: 2035-10-25Patent 12605385Patent 11129833: 2035-10-28Patent 11129833
Patent expiryExclusivity endToday

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
96299599 mo ago
Product
85625649 mo ago
Product
114464419 mo ago
Product
95331029 mo ago
Product
80213353 d ago
Product
11684723in 2 yr 6 mo
Product
9867949in 2 yr 6 mo
Product
10709844in 2 yr 6 mo
Product
8664231in 2 yr 8 mo
U-1442
8480631in 3 yr 6 mo
ProductU-1442
8945063in 3 yr 6 mo
ProductU-1442
9421333in 3 yr 6 mo
ProductU-1442
8579865in 3 yr 6 mo
ProductU-1442
12357642in 3 yr 6 mo
Product
11497753in 3 yr 6 mo
Product
8814834in 4 yr 8 mo
Product
11771701in 8 yr 2 mo
ProductU-3700
12605385in 9 yr 2 mo
Product
11129833in 9 yr 2 mo
Product

Approval history

FDA approval span
First approval
13 yr 2 mo ago
Most recent approval
3 yr 11 mo ago

Approvals span 2013–2022 across 5 FDA applications.

Brand (NDA) 5100%
Generic (ANDA) 00%

Methotrexate: 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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