Is there a generic for Acetaminophen; ibuprofen?

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.

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

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.

What patents protect Acetaminophen; ibuprofen?

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.

Does Acetaminophen; ibuprofen have FDA marketing exclusivity?

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.

What dosage forms of Acetaminophen; ibuprofen are approved?

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

FDA Orange Book · active-ingredient family

Acetaminophen; ibuprofen

Acetaminophen; ibuprofen: 2 brands, 10 generics; first approved Feb 28, 2020; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available — 10 ANDA applications approved.

Earliest patent expiry Feb 27, 2039Latest exclusivity ends Mar 01, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 27, 2039

in 12 yr 10 mo

Originator applications

Brand (NDA) products

COMBOGESICRLDRS

AFT PHARMS USNDA 2094712023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
325MG;97.5MG	TABLET	ORAL	Rx	—

ADVIL DUAL ACTION WITH ACETAMINOPHENRLDRS

HALEON US HOLDINGSNDA 2117332020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;125MG	TABLET	ORAL	OTC	—

Abbreviated applications

Generic (ANDA) products (10)

ACETAMINOPHEN AND IBUPROFEN

TAROANDA 2190532026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;125MG	TABLET	ORAL	OTC	—

ACETAMINOPHEN AND IBUPROFEN

LNK INTL INCANDA 2201262025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;125MG	TABLET	ORAL	OTC	—

ACETAMINOPHEN AND IBUPROFEN

STRIDES PHARMAANDA 2172412025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;125MG	TABLET	ORAL	Discontinued	—

ACETAMINOPHEN AND IBUPROFEN

DR REDDYSANDA 2182472024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;125MG	TABLET	ORAL	OTC	—

ACETAMINOPHEN AND IBUPROFEN

GLENMARK PHARMS LTDANDA 2183112024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;125MG	TABLET	ORAL	OTC	—

ACETAMINOPHEN AND IBUPROFEN

AUROBINDO PHARMA LTDANDA 2183592024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;125MG	TABLET	ORAL	OTC	—

ACETAMINOPHEN AND IBUPROFEN

BIONPHARMAANDA 2169992023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;125MG	TABLET	ORAL	OTC	—

ACETAMINOPHEN AND IBUPROFEN

GRANULESANDA 2165922023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;125MG	TABLET	ORAL	OTC	—

ACETAMINOPHEN AND IBUPROFEN

MARKSANS PHARMAANDA 2169942023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;125MG	TABLET	ORAL	OTC	—

ACETAMINOPHEN AND IBUPROFEN

L PERRIGO COANDA 2148362023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
250MG;125MG	TABLET	ORAL	OTC	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (1)

NPNew product exclusivity (3 years)
Mar 01, 2026
4 mo ago

Orange Book patent file

Listed patents

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11534407	Feb 27, 2039	in 12 yr 10 mo	ProductU-3553
11197830	Feb 27, 2039	in 12 yr 10 mo	ProductU-3553
11918693	Jul 09, 2041	in 15 yr 3 mo	Product

FDA approval span

Approval history

First approval

Feb 28, 2020

6 yr 6 mo ago

Most recent approval

Jan 02, 2026

6 mo ago

Approvals span 2020–2026 across 12 FDA applications.

Brand (NDA) 217%

Generic (ANDA) 1083%

Acetaminophen; ibuprofen — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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