Orange Book product · Brand (NDA)
PEMAZYRE
PEMIGATINIB
At a glance
Apr 17, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 17, 2020
6 yr 3 mo ago
Today
Exclusivity ends · ODE-292
Orphan-drug exclusivity (7 years)
Apr 17, 2027
in 10 mo
Exclusivity ends · ODE-404
Orphan-drug exclusivity (7 years)
Aug 26, 2029
in 3 yr 3 mo
Patent 10131667 expires
Listed method-of-use patent (U-2809) expiration.
Apr 17, 2034
in 7 yr 11 mo
Patent 9611267 expires
Listed drug substance patent expiration.
Jan 30, 2035
in 8 yr 9 mo
Patent 11466004 expires
Listed method-of-use patent (U-3464) expiration.
May 03, 2039
in 13 yr 1 mo
Patent 11466004 expires
Listed method-of-use patent (U-3465) expiration.
May 03, 2039
in 13 yr 1 mo
Patent 11466004 expires
Listed method-of-use patent (U-3466) expiration.
May 03, 2039
in 13 yr 1 mo
Patent 11628162 expires
Listed method-of-use patent (U-3568) expiration.
Aug 30, 2040
in 14 yr 5 mo
Patent 11628162 expires
Listed method-of-use patent (U-3569) expiration.
Aug 30, 2040
in 14 yr 5 mo
Patent 11628162 expires
Listed method-of-use patent (U-3570) expiration.
Aug 30, 2040
in 14 yr 5 mo
Patent 11628162 expires
Listed method-of-use patent (U-3571) expiration.
Aug 30, 2040
in 14 yr 5 mo
Patent 12552792 expires
Listed drug substance patent expiration.
Oct 03, 2040
in 14 yr 6 mo
Pharmaceutical detail
Active ingredient
PEMIGATINIB
Strength
4.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213736
Product number
001
Marketing status
RX
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.
Marketing exclusivity (2)
- ODE-292Orphan-drug exclusivity (7 years)
Apr 17, 2027
in 10 mo
- ODE-404Orphan-drug exclusivity (7 years)
Aug 26, 2029
in 3 yr 3 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10131667 | Apr 17, 2034 | in 7 yr 11 mo | U-2809 |
| 9611267 | Jan 30, 2035 | in 8 yr 9 mo | SubstanceProduct |
| 11466004 | May 03, 2039 | in 13 yr 1 mo | U-3464 |
| 11466004 | May 03, 2039 | in 13 yr 1 mo | U-3465 |
| 11466004 | May 03, 2039 | in 13 yr 1 mo | U-3466 |
| 11628162 | Aug 30, 2040 | in 14 yr 5 mo | U-3568 |
| 11628162 | Aug 30, 2040 | in 14 yr 5 mo | U-3569 |
| 11628162 | Aug 30, 2040 | in 14 yr 5 mo | U-3570 |
| 11628162 | Aug 30, 2040 | in 14 yr 5 mo | U-3571 |
| 12552792 | Oct 03, 2040 | in 14 yr 6 mo | SubstanceProduct |
