Orange Book product · Brand (NDA)

TRUDHESA

DIHYDROERGOTAMINE MESYLATE

Brand (NDA)NDA 213436RX IMPEL PHARMS

Sep 02, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 02, 2021
4 yr 10 mo ago
Today
Patent 9550036 expires
Listed drug product patent expiration.
Sep 05, 2032
in 6 yr 4 mo
Patent 10507295 expires
Listed drug product patent expiration.
Dec 25, 2032
in 6 yr 7 mo
Patent 10940278 expires
Listed drug product patent expiration.
Jan 23, 2033
in 6 yr 8 mo
Patent 9919117 expires
Listed drug product patent expiration.
Mar 17, 2033
in 6 yr 10 mo
Patent 11266799 expires
Listed drug product patent expiration.
Nov 05, 2036
in 10 yr 6 mo
Patent 11185497 expires
Listed method-of-use patent (U-3218) expiration.
Jan 04, 2039
in 12 yr 9 mo

Active ingredient

DIHYDROERGOTAMINE MESYLATE

Strength

0.725MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 213436

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
9550036	Sep 05, 2032	in 6 yr 4 mo	Product
10507295	Dec 25, 2032	in 6 yr 7 mo	Product
10940278	Jan 23, 2033	in 6 yr 8 mo	Product
9919117	Mar 17, 2033	in 6 yr 10 mo	ProductU-3218
11266799	Nov 05, 2036	in 10 yr 6 mo	Product
11185497	Jan 04, 2039	in 12 yr 9 mo	U-3218