Question 1

Is there a generic for Acetaminophen; ibuprofen?

Accepted Answer

Yes. The FDA Orange Book lists 10 approved generic (ANDA) applications for Acetaminophen; ibuprofen, referencing the brand COMBOGESIC. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

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

Accepted Answer

COMBOGESIC (NDA 209471, AFT PHARMS US) 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?

Accepted Answer

The Orange Book lists 3 patents against Acetaminophen; ibuprofen products, with the earliest listed expiry in 2039. 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 have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Acetaminophen; ibuprofen. 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 are approved?

Accepted Answer

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

Product	Applicant	Application	TE	Approved
COMBOGESICRLD	AFT PHARMS US	NDA 209471	—	Mar 01, 2023
ADVIL DUAL ACTION WITH ACETAMINOPHENRLD	HALEON US HOLDINGS	NDA 211733	—	Feb 28, 2020

Product	Applicant	Application	TE	Approved
ACETAMINOPHEN AND IBUPROFEN	TARO	ANDA 219053	—	Jan 02, 2026
ACETAMINOPHEN AND IBUPROFEN	LNK INTL INC	ANDA 220126	—	Dec 11, 2025
ACETAMINOPHEN AND IBUPROFEN	STRIDES PHARMA	ANDA 217241	—	Jan 17, 2025
ACETAMINOPHEN AND IBUPROFEN	DR REDDYS	ANDA 218247	—	Aug 23, 2024
ACETAMINOPHEN AND IBUPROFEN	GLENMARK PHARMS LTD	ANDA 218311	—	Apr 26, 2024
ACETAMINOPHEN AND IBUPROFEN	AUROBINDO PHARMA LTD	ANDA 218359	—	Mar 26, 2024
ACETAMINOPHEN AND IBUPROFEN	BIONPHARMA	ANDA 216999	—	Aug 01, 2023
ACETAMINOPHEN AND IBUPROFEN	GRANULES	ANDA 216592	—	Jul 13, 2023
ACETAMINOPHEN AND IBUPROFEN	MARKSANS PHARMA	ANDA 216994	—	Jul 10, 2023
ACETAMINOPHEN AND IBUPROFEN	L PERRIGO CO	ANDA 214836	—	Feb 28, 2023

Patent	Expires	In	Type
11534407	Feb 27, 2039	in 12 yr 11 mo	ProductU-3553
11197830	Feb 27, 2039	in 12 yr 11 mo	ProductU-3553
11918693	Jul 09, 2041	in 15 yr 3 mo	Product

Acetaminophen; ibuprofen

Brand (NDA) products · tablet

Generic (ANDA) products (10)

Marketing exclusivity (1)

Listed patents (3)

Acetaminophen; ibuprofen — frequently asked questions

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