Orange Book product · Brand (NDA)

ELIQUIS SPRINKLE

APIXABAN

Brand (NDA)NDA 220073RX BRISTOL

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 · NP
New product 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 11896586 expires
Listed drug product patent expiration.
Nov 22, 2040
in 14 yr 8 mo
Patent 11896586*PED expires
Listed listed patent expiration.
May 22, 2041
in 15 yr 2 mo

Active ingredient

APIXABAN

Strength

0.15MG

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 220073

Product number

001

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-4180
6967208*PED	May 21, 2027	in 11 mo
11896586	Nov 22, 2040	in 14 yr 8 mo	ProductU-4180
11896586*PED	May 22, 2041	in 15 yr 2 mo