Orange Book product · Brand (NDA)

PYRIDOSTIGMINE BROMIDE

Brand (NDA)NDA 217604DISCN AMNEAL

Oct 04, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 04, 2024
1 yr 9 mo ago
Today
Patent 10881617 expires
Listed drug product patent expiration.
Jun 18, 2038
in 12 yr 2 mo
Patent 10925833 expires
Listed drug product patent expiration.
Jun 18, 2038
in 12 yr 2 mo
Patent 10987311 expires
Listed drug product patent expiration.
Jun 18, 2038
in 12 yr 2 mo
Patent 11229606 expires
Listed drug product patent expiration.
Jun 18, 2038
in 12 yr 2 mo
Patent 11478425 expires
Listed drug product patent expiration.
Jun 18, 2038
in 12 yr 2 mo
Patent 11666536 expires
Listed drug product patent expiration.
Jun 18, 2038
in 12 yr 2 mo
Patent 11911515 expires
Listed drug product patent expiration.
Jun 18, 2038
in 12 yr 2 mo
Patent 12042559 expires
Listed drug product patent expiration.
Jun 18, 2038
in 12 yr 2 mo
Patent 12233166 expires
Listed drug product patent expiration.
Jun 18, 2038
in 12 yr 2 mo

Active ingredient

PYRIDOSTIGMINE BROMIDE

Strength

105MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 217604

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Reference standard (RS)

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10881617	Jun 18, 2038	in 12 yr 2 mo	Product
10925833	Jun 18, 2038	in 12 yr 2 mo	Product
10987311	Jun 18, 2038	in 12 yr 2 mo	Product
11229606	Jun 18, 2038	in 12 yr 2 mo	Product
11478425	Jun 18, 2038	in 12 yr 2 mo	ProductU-4012
11666536	Jun 18, 2038	in 12 yr 2 mo	Product
11911515	Jun 18, 2038	in 12 yr 2 mo	Product
12042559	Jun 18, 2038	in 12 yr 2 mo	Product
12233166	Jun 18, 2038	in 12 yr 2 mo	Product