Orange Book product · Brand (NDA)
EVRYSDI
RISDIPLAM
At a glance
Aug 07, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 07, 2020
5 yr 11 mo ago
Today
Exclusivity ends · M-270
New use / labeling-change exclusivity (3 years)
Oct 03, 2026
in 4 mo
Exclusivity ends · ODE-334
Orphan-drug exclusivity (7 years)
Aug 07, 2027
in 1 yr 2 mo
Exclusivity ends · ODE-400
Orphan-drug exclusivity (7 years)
May 27, 2029
in 3 yr
Patent 9586955 expires
Listed drug substance patent expiration.
Feb 08, 2033
in 6 yr 9 mo
Patent 9969754 expires
Listed drug substance patent expiration.
May 11, 2035
in 9 yr
Patent 11827646 expires
Listed method-of-use patent (U-1943) expiration.
Jan 25, 2036
in 9 yr 9 mo
Patent 11938136 expires
Listed drug product patent expiration.
Nov 08, 2036
in 10 yr 7 mo
Patent 12350273 expires
Listed method-of-use patent (U-1943) expiration.
Oct 01, 2038
in 12 yr 6 mo
Patent 11534444 expires
Listed method-of-use patent (U-1943) expiration.
Oct 04, 2038
in 12 yr 6 mo
Patent 12122789 expires
Listed drug substance patent expiration.
Apr 15, 2041
in 15 yr
Pharmaceutical detail
Active ingredient
RISDIPLAM
Strength
0.75MG/ML
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 213535
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.
Marketing exclusivity (3)
- M-270New use / labeling-change exclusivity (3 years)
Oct 03, 2026
in 4 mo
- ODE-334Orphan-drug exclusivity (7 years)
Aug 07, 2027
in 1 yr 2 mo
- ODE-400Orphan-drug exclusivity (7 years)
May 27, 2029
in 3 yr
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9586955 | Feb 08, 2033 | in 6 yr 9 mo | SubstanceProduct |
| 9969754 | May 11, 2035 | in 9 yr | SubstanceProductU-1943 |
| 11827646 | Jan 25, 2036 | in 9 yr 9 mo | U-1943 |
| 11938136 | Nov 08, 2036 | in 10 yr 7 mo | Product |
| 12350273 | Oct 01, 2038 | in 12 yr 6 mo | U-1943 |
| 11534444 | Oct 04, 2038 | in 12 yr 6 mo | U-1943 |
| 12122789 | Apr 15, 2041 | in 15 yr | SubstanceProduct |
