Orange Book product · Brand (NDA)
OTREXUP
METHOTREXATE
At a glance
Nov 07, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
15
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 07, 2014
11 yr 9 mo ago
Patent 11446441 expires
Listed drug product patent expiration.
Jan 24, 2026
5 mo ago
Patent 8562564 expires
Listed drug product patent expiration.
Jan 24, 2026
5 mo ago
Patent 9533102 expires
Listed drug product patent expiration.
Jan 24, 2026
5 mo ago
Patent 9629959 expires
Listed drug product patent expiration.
Jan 24, 2026
5 mo ago
Today
Patent 8021335 expires
Listed drug product patent expiration.
Oct 04, 2026
in 4 mo
Patent 10709844 expires
Listed drug product patent expiration.
Mar 10, 2029
in 2 yr 9 mo
Patent 11684723 expires
Listed drug product patent expiration.
Mar 10, 2029
in 2 yr 9 mo
Patent 9867949 expires
Listed drug product patent expiration.
Mar 10, 2029
in 2 yr 9 mo
Patent 11497753 expires
Listed drug product patent expiration.
Mar 19, 2030
in 3 yr 10 mo
Patent 12357642 expires
Listed drug product patent expiration.
Mar 19, 2030
in 3 yr 10 mo
Patent 8480631 expires
Listed drug product patent expiration.
Mar 19, 2030
in 3 yr 10 mo
Patent 8579865 expires
Listed drug product patent expiration.
Mar 19, 2030
in 3 yr 10 mo
Patent 8945063 expires
Listed drug product patent expiration.
Mar 19, 2030
in 3 yr 10 mo
Patent 9421333 expires
Listed drug product patent expiration.
Mar 19, 2030
in 3 yr 10 mo
Patent 8814834 expires
Listed drug product patent expiration.
May 27, 2031
in 5 yr
Pharmaceutical detail
Active ingredient
METHOTREXATE
Strength
7.5MG/0.4ML (7.5MG/0.4ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 204824
Product number
005
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
Listed patents (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11446441 | Jan 24, 2026 | 5 mo ago | Product |
| 8562564 | Jan 24, 2026 | 5 mo ago | Product |
| 9533102 | Jan 24, 2026 | 5 mo ago | Product |
| 9629959 | Jan 24, 2026 | 5 mo ago | Product |
| 8021335 | Oct 04, 2026 | in 4 mo | Product |
| 10709844 | Mar 10, 2029 | in 2 yr 9 mo | Product |
| 11684723 | Mar 10, 2029 | in 2 yr 9 mo | Product |
| 9867949 | Mar 10, 2029 | in 2 yr 9 mo | Product |
| 11497753 | Mar 19, 2030 | in 3 yr 10 mo | Product |
| 12357642 | Mar 19, 2030 | in 3 yr 10 mo | Product |
| 8480631 | Mar 19, 2030 | in 3 yr 10 mo | ProductU-1442 |
| 8579865 | 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 |
| 8814834 | May 27, 2031 | in 5 yr | Product |
