Question 1

Is there a generic for Acetaminophen; ibuprofen sodium?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Acetaminophen; ibuprofen sodium. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Acetaminophen; ibuprofen sodium?

Accepted Answer

COMBOGESIC IV (NDA 215320, HIKMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Acetaminophen; ibuprofen sodium?

Accepted Answer

The Orange Book lists 6 patents against Acetaminophen; ibuprofen sodium products, with the earliest listed expiry in 2031. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Acetaminophen; ibuprofen sodium have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Acetaminophen; ibuprofen sodium. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Acetaminophen; ibuprofen sodium are approved?

Accepted Answer

Acetaminophen; ibuprofen sodium is approved in the following dosage form: solution.

Patent	Expires	In	Type
12220392	Oct 26, 2031	in 5 yr 5 mo	U-4306
11446266	Oct 26, 2031	in 5 yr 5 mo	U-3744
11896567	Oct 26, 2031	in 5 yr 5 mo	U-3744
12083087	Jul 17, 2035	in 9 yr 3 mo	U-3744
11389416	Jul 17, 2035	in 9 yr 3 mo	Product
11213498	Jan 14, 2036	in 9 yr 9 mo	Product

Acetaminophen; ibuprofen sodium

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (6)

Acetaminophen; ibuprofen sodium — frequently asked questions

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