Orange Book product · Brand (NDA)
XATMEP
METHOTREXATE SODIUM
At a glance
Apr 25, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 25, 2017
9 yr 3 mo ago
Today
Patent 10231927 expires
Listed method-of-use patent (U-1699) expiration.
Jan 02, 2033
in 6 yr 8 mo
Patent 10231927 expires
Listed method-of-use patent (U-1349) expiration.
Jan 02, 2033
in 6 yr 8 mo
Patent 10610485 expires
Listed drug product patent expiration.
Jan 02, 2033
in 6 yr 8 mo
Patent 11116724 expires
Listed method-of-use patent (U-1349) expiration.
Jan 02, 2033
in 6 yr 8 mo
Patent 11116724 expires
Listed method-of-use patent (U-1699) expiration.
Jan 02, 2033
in 6 yr 8 mo
Patent 11969503 expires
Listed drug product patent expiration.
Jan 02, 2033
in 6 yr 8 mo
Patent 12396947 expires
Listed drug product patent expiration.
Jan 02, 2033
in 6 yr 8 mo
Patent 9259427 expires
Listed drug product patent expiration.
Jan 02, 2033
in 6 yr 8 mo
Patent 9855215 expires
Listed drug product patent expiration.
Jan 02, 2033
in 6 yr 8 mo
Pharmaceutical detail
Active ingredient
METHOTREXATE SODIUM
Strength
EQ 2.5MG BASE/ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 208400
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1982METHOTREXATE LPFBrand (NDA)
NDA 011719 · HOSPIRA
- 2026METHOTREXATE SODIUMGeneric (ANDA)
ANDA 219865 · HETERO LABS LTD VI
- 2026METHOTREXATE SODIUMGeneric (ANDA)
ANDA 220225 · ALEMBIC
- 2024METHOTREXATE SODIUMGeneric (ANDA)
ANDA 217552 · ALEMBIC
- 2024METHOTREXATE SODIUMGeneric (ANDA)
ANDA 216453 · ELITE LABS INC
- 2023METHOTREXATE SODIUMGeneric (ANDA)
ANDA 213362 · DAITO
- 2021METHOTREXATE SODIUMGeneric (ANDA)
ANDA 209787 · LOTUS PHARM CO LTD
- 2020METHOTREXATE SODIUMGeneric (ANDA)
ANDA 210454 · EUGIA PHARMA
- 2020METHOTREXATE SODIUMGeneric (ANDA)
ANDA 213343 · ACCORD HLTHCARE
- 2018METHOTREXATE SODIUM PRESERVATIVE FREEGeneric (ANDA)
ANDA 203407 · SAGENT PHARMS INC
- 2017METHOTREXATE SODIUMGeneric (ANDA)
ANDA 210040 · AMNEAL PHARMS
- 2012METHOTREXATE SODIUM PRESERVATIVE FREEGeneric (ANDA)
ANDA 201529 · EUGIA PHARMA SPECLTS
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10231927 | Jan 02, 2033 | in 6 yr 8 mo | U-1699 |
| 10231927 | Jan 02, 2033 | in 6 yr 8 mo | U-1349 |
| 10610485 | Jan 02, 2033 | in 6 yr 8 mo | Product |
| 11116724 | Jan 02, 2033 | in 6 yr 8 mo | U-1349 |
| 11116724 | Jan 02, 2033 | in 6 yr 8 mo | U-1699 |
| 11969503 | Jan 02, 2033 | in 6 yr 8 mo | Product |
| 12396947 | Jan 02, 2033 | in 6 yr 8 mo | Product |
| 9259427 | Jan 02, 2033 | in 6 yr 8 mo | Product |
| 9855215 | Jan 02, 2033 | in 6 yr 8 mo | Product |
