methotrexate sodium · Hospira · NDA 008085, 011719, 020079
Methotrexate Sodium
Earliest generic entry, as listed
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 219865, Hetero Labs Ltd Vi · 011719-001Approved 30 Apr 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220225, Alembic · 011719-001Approved 15 Apr 2026Detected 25 Oct 2026Historical import
Products covered · 8
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 008085 · 002 · RLD · discontinued | tablet, oral | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011719 · 001 · RLD · discontinued | injectable, injection | EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011719 · 003 · RLD · discontinued | injectable, injection | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011719 · 004 · RLD · discontinued | injectable, injection | EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011719 · 005 · RLD · discontinued | injectable, injection | EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011719 · 006 · RLD · discontinued | injectable, injection | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 011719 · 010 · RLD | injectable, injection | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | open |
| 020079 · 001 · discontinued | solution, irrigation | 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML | open |