Orange Book product · Brand (NDA)

CALDOLOR

IBUPROFEN

Brand (NDA)NDA 022348RX CUMBERLAND PHARMS

Jun 11, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 11, 2009
17 yr 3 mo ago
Exclusivity ends · NPP
New patient population exclusivity (3 years)
May 11, 2026
1 mo ago
Today
Patent 8735452 expires
Listed method-of-use patent (U-981) expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 8871810 expires
Listed method-of-use patent (U-981) expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 9114068 expires
Listed method-of-use patent (U-1735) expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 9138404 expires
Listed method-of-use patent (U-1756) expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 9295639 expires
Listed method-of-use patent (U-1756) expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 9649284 expires
Listed method-of-use patent (U-2018) expiration.
Sep 30, 2029
in 3 yr 4 mo
Patent 9012508 expires
Listed method-of-use patent (U-981) expiration.
Sep 14, 2030
in 4 yr 4 mo
Patent 11806400 expires
Listed method-of-use patent (U-3746) expiration.
Mar 16, 2032
in 5 yr 10 mo

Active ingredient

IBUPROFEN

Strength

800MG/8ML (100MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 022348

Product number

002

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
8735452	Sep 30, 2029	in 3 yr 4 mo	U-981
8871810	Sep 30, 2029	in 3 yr 4 mo	U-981
9114068	Sep 30, 2029	in 3 yr 4 mo	U-1735
9138404	Sep 30, 2029	in 3 yr 4 mo	U-1756
9295639	Sep 30, 2029	in 3 yr 4 mo	U-1756
9649284	Sep 30, 2029	in 3 yr 4 mo	U-2018
9012508	Sep 14, 2030	in 4 yr 4 mo	U-981
11806400	Mar 16, 2032	in 5 yr 10 mo	U-3746