Orange Book product · Brand (NDA)

LYVISPAH

BACLOFEN

Brand (NDA)NDA 215422DISCN STRIDES PHARMA INTL

Nov 22, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 22, 2021
4 yr 8 mo ago
Today
Patent 10792262 expires
Listed drug product patent expiration.
Jul 29, 2039
in 13 yr 4 mo
Patent 11654124 expires
Listed drug product patent expiration.
Jul 29, 2039
in 13 yr 4 mo
Patent 11931328 expires
Listed drug product patent expiration.
Jul 29, 2039
in 13 yr 4 mo
Patent 11491125 expires
Listed drug product patent expiration.
Sep 29, 2041
in 15 yr 6 mo
Patent 11491125 expires
Listed drug product patent expiration.
Sep 29, 2041
in 15 yr 6 mo
Patent 11850225 expires
Listed drug product patent expiration.
Sep 29, 2041
in 15 yr 6 mo
Patent 11850225 expires
Listed drug product patent expiration.
Sep 29, 2041
in 15 yr 6 mo

Active ingredient

BACLOFEN

Strength

20MG/PACKET

Dosage form

GRANULE

Route

ORAL

TE code

Not listed

Application

NDA 215422

Product number

003

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
10792262	Jul 29, 2039	in 13 yr 4 mo	ProductU-3263
11654124	Jul 29, 2039	in 13 yr 4 mo	Product
11931328	Jul 29, 2039	in 13 yr 4 mo	Product
11491125	Sep 29, 2041	in 15 yr 6 mo	ProductU-3489
11491125	Sep 29, 2041	in 15 yr 6 mo	ProductU-3488
11850225	Sep 29, 2041	in 15 yr 6 mo	ProductU-3489
11850225	Sep 29, 2041	in 15 yr 6 mo	ProductU-3488