Orange Book product · Brand (NDA)

IGALMI

DEXMEDETOMIDINE HYDROCHLORIDE

Brand (NDA)NDA 215390RX BIOXCEL

View DEXMEDETOMIDINE HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Apr 05, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Apr 05, 2022
4 yr 3 mo ago
Today
Exclusivity ends · M-82
New use / labeling-change exclusivity (3 years)
Nov 19, 2028
in 2 yr 5 mo
Patent 11786508 expires
Listed method-of-use patent (U-3698) expiration.
Dec 29, 2037
in 11 yr 8 mo
Patent 11839604 expires
Listed method-of-use patent (U-3756) expiration.
Dec 29, 2037
in 11 yr 8 mo
Patent 10792246 expires
Listed drug product patent expiration.
Jun 26, 2039
in 13 yr 3 mo
Patent 11478422 expires
Listed drug product patent expiration.
Jun 26, 2039
in 13 yr 3 mo
Patent 11497711 expires
Listed drug product patent expiration.
Jun 26, 2039
in 13 yr 3 mo
Patent 11517524 expires
Listed drug product patent expiration.
Jun 26, 2039
in 13 yr 3 mo
Patent 11890272 expires
Listed method-of-use patent (U-3935) expiration.
Jul 17, 2040
in 14 yr 3 mo
Patent 11890272 expires
Listed method-of-use patent (U-3756) expiration.
Jul 17, 2040
in 14 yr 3 mo
Patent 11998529 expires
Listed method-of-use patent (U-3935) expiration.
Jul 17, 2040
in 14 yr 3 mo
Patent 12109196 expires
Listed method-of-use patent (U-3935) expiration.
Jul 17, 2040
in 14 yr 3 mo
Patent 11806334 expires
Listed method-of-use patent (U-3725) expiration.
Jan 12, 2043
in 16 yr 10 mo
Patent 11998528 expires
Listed method-of-use patent (U-3935) expiration.
Jan 12, 2043
in 16 yr 10 mo
Patent 12090140 expires
Listed method-of-use patent (U-3986) expiration.
Jan 12, 2043
in 16 yr 10 mo
Patent 12138247 expires
Listed method-of-use patent (U-4029) expiration.
Jan 12, 2043
in 16 yr 10 mo
Patent 12364683 expires
Listed method-of-use patent (U-4029) expiration.
Jan 12, 2043
in 16 yr 10 mo

Pharmaceutical detail

Active ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Strength

EQ 0.12MG BASE

Dosage form

FILM

Route

BUCCAL, SUBLINGUAL

TE code

Not listed

Application

NDA 215390

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

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

Marketing exclusivity (1)

M-82New use / labeling-change exclusivity (3 years)
Nov 19, 2028
in 2 yr 5 mo

Listed patents (15)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11786508	Dec 29, 2037	in 11 yr 8 mo	U-3698
11839604	Dec 29, 2037	in 11 yr 8 mo	U-3756
10792246	Jun 26, 2039	in 13 yr 3 mo	ProductU-3350
11478422	Jun 26, 2039	in 13 yr 3 mo	Product
11497711	Jun 26, 2039	in 13 yr 3 mo	ProductU-3645
11517524	Jun 26, 2039	in 13 yr 3 mo	ProductU-3645
11890272	Jul 17, 2040	in 14 yr 3 mo	U-3935
11890272	Jul 17, 2040	in 14 yr 3 mo	U-3756
11998529	Jul 17, 2040	in 14 yr 3 mo	U-3935
12109196	Jul 17, 2040	in 14 yr 3 mo	U-3935
11806334	Jan 12, 2043	in 16 yr 10 mo	U-3725
11998528	Jan 12, 2043	in 16 yr 10 mo	U-3935
12090140	Jan 12, 2043	in 16 yr 10 mo	U-3986
12138247	Jan 12, 2043	in 16 yr 10 mo	U-4029
12364683	Jan 12, 2043	in 16 yr 10 mo	U-4029

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