Is There a Generic for Caldolor?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Caldolor (ibuprofen). The Orange Book shows its last listed patent expires March 16, 2032 and its last listed exclusivity ends May 11, 2026.

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Caldolor products in the Orange Book

Caldolor products and approved generics
Form and route	Strength	Brand status	Brand TE	Generic TE codes
solution, intravenous	400MG/4ML (100MG/ML)	Discontinued	None	None
solution, intravenous	800MG/200ML (4MG/ML)	Marketed (Rx)	None	None
solution, intravenous	800MG/8ML (100MG/ML)	Marketed (Rx)	None	None

NDA 022348, held by APOTEX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Caldolor patents

Patents listed for Caldolor
Patent	Expires	Covers	Use code	NDA
9114068	September 30, 2029	Method of use	U-1735	022348
8735452	September 30, 2029	Method of use	U-981	022348
9649284	September 30, 2029	Method of use	U-2018	022348
8871810	September 30, 2029	Method of use	U-981	022348
9295639	September 30, 2029	Method of use	U-1756	022348
9138404	September 30, 2029	Method of use	U-1756	022348
9012508	September 14, 2030	Method of use	U-981	022348
11806400	March 16, 2032	Method of use	U-3746	022348
9072661	March 16, 2032	Method of use	U-2264	022348
9072710	March 16, 2032	Method of use	U-2266	022348

Caldolor exclusivity

Exclusivity listed for Caldolor
Code	Meaning	Expires	NDA
NPP	New patient population	May 11, 2026	022348

Caldolor NDC codes

Questions

Is there a generic for Caldolor?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Caldolor (ibuprofen). The Orange Book shows its last listed patent expires March 16, 2032 and its last listed exclusivity ends May 11, 2026.

What is the generic name for Caldolor?

The active ingredient in Caldolor is ibuprofen, per the FDA Orange Book.

When does the Caldolor patent expire?

The last patent listed for Caldolor in the Orange Book expires March 16, 2032. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.