Orange Book product · Brand (NDA)

LONHALA MAGNAIR KIT

GLYCOPYRROLATE

Brand (NDA)NDA 208437DISCN SUMITOMO PHARMA AM

Dec 05, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 05, 2017
8 yr 8 mo ago
Today
Patent 11278683 expires
Listed drug product patent expiration.
Aug 16, 2026
in 2 mo
Patent 9265900 expires
Listed drug product patent expiration.
Dec 07, 2028
in 2 yr 6 mo
Patent 10940110 expires
Listed drug product patent expiration.
Feb 26, 2029
in 2 yr 9 mo
Patent 9789270 expires
Listed drug product patent expiration.
Oct 30, 2030
in 4 yr 5 mo
Patent 9168556 expires
Listed drug product patent expiration.
Sep 01, 2032
in 6 yr 4 mo
Patent 9604018 expires
Listed drug product patent expiration.
May 16, 2033
in 7 yr
Patent 10376661 expires
Listed drug product patent expiration.
Sep 14, 2035
in 9 yr 4 mo
Patent 10688518 expires
Listed drug product patent expiration.
Nov 12, 2036
in 10 yr 7 mo
Patent 10744277 expires
Listed drug product patent expiration.
Dec 07, 2036
in 10 yr 7 mo

Active ingredient

GLYCOPYRROLATE

Strength

25MCG/ML

Dosage form

SOLUTION

Route

INHALATION

TE code

Not listed

Application

NDA 208437

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
11278683	Aug 16, 2026	in 2 mo	Product
9265900	Dec 07, 2028	in 2 yr 6 mo	Product
10940110	Feb 26, 2029	in 2 yr 9 mo	ProductU-1773
9789270	Oct 30, 2030	in 4 yr 5 mo	Product
9168556	Sep 01, 2032	in 6 yr 4 mo	Product
9604018	May 16, 2033	in 7 yr	Product
10376661	Sep 14, 2035	in 9 yr 4 mo	Product
10688518	Nov 12, 2036	in 10 yr 7 mo	Product
10744277	Dec 07, 2036	in 10 yr 7 mo	ProductU-2941