Orange Book product · Brand (NDA)
PEMFEXY
PEMETREXED
At a glance
Feb 08, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 08, 2020
6 yr 5 mo ago
Today
Patent 9604990 expires
Listed drug substance patent expiration.
Oct 28, 2035
in 9 yr 6 mo
Patent 11793813 expires
Listed drug product patent expiration.
Feb 19, 2036
in 9 yr 10 mo
Patent 12115164 expires
Listed method-of-use patent (U-4246) expiration.
Feb 19, 2036
in 9 yr 10 mo
Patent 12115164 expires
Listed method-of-use patent (U-4247) expiration.
Feb 19, 2036
in 9 yr 10 mo
Patent 12115164 expires
Listed method-of-use patent (U-4248) expiration.
Feb 19, 2036
in 9 yr 10 mo
Pharmaceutical detail
Active ingredient
PEMETREXED
Strength
500MG/20ML (25MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 209472
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.
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9604990 | Oct 28, 2035 | in 9 yr 6 mo | Substance |
| 11793813 | Feb 19, 2036 | in 9 yr 10 mo | Product |
| 12115164 | Feb 19, 2036 | in 9 yr 10 mo | U-4246 |
| 12115164 | Feb 19, 2036 | in 9 yr 10 mo | U-4247 |
| 12115164 | Feb 19, 2036 | in 9 yr 10 mo | U-4248 |
