Orange Book product · Brand (NDA)

LYRICA CR

PREGABALIN

Brand (NDA)NDA 209501TE ABRX UPJOHN

Oct 11, 2017

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 11, 2017
8 yr 10 mo ago
Today
Patent 10022447 expires
Listed method-of-use patent (U-2137) expiration.
Nov 02, 2026
in 5 mo
Patent 10022447 expires
Listed method-of-use patent (U-2136) expiration.
Nov 02, 2026
in 5 mo
Patent 8945620 expires
Listed drug product patent expiration.
Nov 02, 2026
in 5 mo
Patent 8945620 expires
Listed drug product patent expiration.
Nov 02, 2026
in 5 mo
Patent 9144559 expires
Listed drug product patent expiration.
Nov 02, 2026
in 5 mo
Patent 10022447*PED expires
Listed listed patent expiration.
May 02, 2027
in 11 mo
Patent 8945620*PED expires
Listed listed patent expiration.
May 02, 2027
in 11 mo
Patent 9144559*PED expires
Listed listed patent expiration.
May 02, 2027
in 11 mo

Active ingredient

PREGABALIN

Strength

82.5MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 209501

Product number

001

Marketing status

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
10022447	Nov 02, 2026	in 5 mo	U-2137
10022447	Nov 02, 2026	in 5 mo	U-2136
8945620	Nov 02, 2026	in 5 mo	ProductU-2136
8945620	Nov 02, 2026	in 5 mo	ProductU-2137
9144559	Nov 02, 2026	in 5 mo	Product
10022447*PED	May 02, 2027	in 11 mo
8945620*PED	May 02, 2027	in 11 mo
9144559*PED	May 02, 2027	in 11 mo