FDA Orange Book · active-ingredient family
Methotrexate
Methotrexate is approved in 5 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:JYLAMVO · NDA 212479
5
Brand (NDA)
0
Generics (ANDA)
19
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| JYLAMVORLD | SHORLA | NDA 212479 | — | Nov 29, 2022 | |
| METHOTREXATERLD | ACCORD HLTHCARE | NDA 214121 | — | Aug 24, 2020 | |
| REDITREXRLD×8 | NORDIC GRP | NDA 210737 | — | Nov 27, 2019 | |
| OTREXUPRLD×14 | ASSERTIO SPECLTY | NDA 204824 | — | Nov 07, 2014 | |
| RASUVORLD×10 | MEDEXUS | NDA 205776 | — | Jul 10, 2014 |
Listed patents (19)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9629959 | Jan 24, 2026 | 5 mo ago | Product |
| 8562564 | Jan 24, 2026 | 5 mo ago | Product |
| 11446441 | Jan 24, 2026 | 5 mo ago | Product |
| 9533102 | Jan 24, 2026 | 5 mo ago | Product |
| 8021335 | Oct 04, 2026 | in 4 mo | Product |
| 11684723 | Mar 10, 2029 | in 2 yr 9 mo | Product |
| 9867949 | Mar 10, 2029 | in 2 yr 9 mo | Product |
| 10709844 | Mar 10, 2029 | in 2 yr 9 mo | Product |
| 8664231 | Jun 01, 2029 | in 3 yr | U-1442 |
| 8480631 | Mar 19, 2030 | in 3 yr 10 mo | ProductU-1442 |
| 8945063 | Mar 19, 2030 | in 3 yr 10 mo | ProductU-1442 |
| 9421333 | Mar 19, 2030 | in 3 yr 10 mo | ProductU-1442 |
| 8579865 | Mar 19, 2030 | in 3 yr 10 mo | ProductU-1442 |
| 12357642 | Mar 19, 2030 | in 3 yr 10 mo | Product |
| 11497753 | Mar 19, 2030 | in 3 yr 10 mo | Product |
| 8814834 | May 27, 2031 | in 5 yr | Product |
| 11771701 | Oct 29, 2034 | in 8 yr 6 mo | ProductU-3700 |
| 12605385 | Oct 25, 2035 | in 9 yr 6 mo | Product |
| 11129833 | Oct 28, 2035 | in 9 yr 6 mo | Product |
Methotrexate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
