Orange Book product · Brand (NDA)

ELIQUIS

APIXABAN

Brand (NDA)NDA 202155RX BRISTOL MYERS SQUIBB

Apr 17, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 17, 2025
1 yr 2 mo ago
Today
Patent 6967208 expires
Listed drug substance patent expiration.
Nov 21, 2026
in 5 mo
Patent 6967208*PED expires
Listed listed patent expiration.
May 21, 2027
in 11 mo
Exclusivity ends · NS
New strength exclusivity (3 years)
Apr 17, 2028
in 1 yr 10 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Oct 17, 2028
in 2 yr 4 mo
Patent 9326945 expires
Listed drug product patent expiration.
Feb 24, 2031
in 4 yr 9 mo
Patent 9326945*PED expires
Listed listed patent expiration.
Aug 24, 2031
in 5 yr 3 mo

Active ingredient

APIXABAN

Strength

0.5MG

Dosage form

TABLET, FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 202155

Product number

003

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
6967208	Nov 21, 2026	in 5 mo	SubstanceProductU-4179
6967208*PED	May 21, 2027	in 11 mo
9326945	Feb 24, 2031	in 4 yr 9 mo	Product
9326945*PED	Aug 24, 2031	in 5 yr 3 mo