Orange Book product · Brand (NDA)

ATZUMI

DIHYDROERGOTAMINE MESYLATE

Brand (NDA)NDA 217901RX SATSUMA PHARMS

Apr 30, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 30, 2025
1 yr 2 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Apr 30, 2028
in 1 yr 11 mo
Patent 12594273 expires
Listed drug product patent expiration.
Sep 24, 2033
in 7 yr 4 mo
Patent 10792253 expires
Listed drug product patent expiration.
Aug 04, 2037
in 11 yr 3 mo
Patent 11872314 expires
Listed drug product patent expiration.
Aug 04, 2037
in 11 yr 3 mo
Patent 10758532 expires
Listed drug product patent expiration.
Dec 11, 2039
in 13 yr 8 mo
Patent 12263162 expires
Listed drug product patent expiration.
Dec 11, 2039
in 13 yr 8 mo
Patent 11744967 expires
Listed drug product patent expiration.
Oct 12, 2041
in 15 yr 6 mo
Patent 12102754 expires
Listed drug product patent expiration.
Oct 12, 2041
in 15 yr 6 mo

Active ingredient

DIHYDROERGOTAMINE MESYLATE

Strength

EQ 5.2MG BASE

Dosage form

POWDER

Route

NASAL

TE code

Not listed

Application

NDA 217901

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12594273	Sep 24, 2033	in 7 yr 4 mo	Product
10792253	Aug 04, 2037	in 11 yr 3 mo	Product
11872314	Aug 04, 2037	in 11 yr 3 mo	Product
10758532	Dec 11, 2039	in 13 yr 8 mo	Product
12263162	Dec 11, 2039	in 13 yr 8 mo	Product
11744967	Oct 12, 2041	in 15 yr 6 mo	Product
12102754	Oct 12, 2041	in 15 yr 6 mo	Product