Is Advil Allergy Sinus still available?

Yes. Advil Allergy Sinus (NDA 021441) is listed with marketing status Over-the-counter in the FDA Orange Book.

Does Advil Allergy Sinus have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Advil Allergy Sinus's active ingredient (Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride).

When do Advil Allergy Sinus's patents expire?

The FDA Orange Book lists 1 patent against Advil Allergy Sinus, with the last listed patent expiring Feb 28, 2027. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Advil Allergy Sinus's FDA application number?

Advil Allergy Sinus is approved under NDA 021441, held by Haleon US Holdings.

Orange Book product · Brand (NDA)

Advil Allergy Sinus

Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride

Brand (NDA)NDA 021441RLD Haleon US Holdings

Approved

Dec 19, 2002

Application

Brand (NDA)

TE code

Not listed

Listed patents

Advil Allergy Sinus (Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride) is Haleon US Holdings's brand-name drug, approved by the FDA under NDA 021441 in 2002. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. The FDA Orange Book lists 1 patent against it, the last expiring 2027.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Dec 19, 2002
23 yr 11 mo ago
Today
Patent 7863287 expires
Listed drug product patent expiration.
Feb 28, 2027
in 8 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Strength

2MG;200MG;30MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 021441

Product number

001

Marketing status

Over-the-counter

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Children's Advil Allergy SinusBrand (NDA)
NDA 021587 · Haleon US Holdings
2004

View full Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride family

Orange Book patent file

Listed patents

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7863287	Feb 28, 2027	in 8 mo	Product

Advil Allergy Sinus — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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