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ADVIL ALLERGY SINUS Drug Patent Profile

When do Advil Allergy Sinus patents expire, and what generic alternatives are available?

Advil Allergy Sinus is a drug marketed by Haleon Us Holdings and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-four patent family members in eighteen countries.

The generic ingredient in ADVIL ALLERGY SINUS is chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Advil Allergy Sinus

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 28, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ADVIL ALLERGY SINUS

International Patents:	34
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	15
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in ADVIL ALLERGY SINUS?	ADVIL ALLERGY SINUS excipients list
DailyMed Link:	ADVIL ALLERGY SINUS at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ADVIL ALLERGY SINUS

NDA:

021441

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ADVIL ALLERGY SINUS

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ADVIL ALLERGY SINUS

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R06AB	Substituted alkylamines
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ADVIL ALLERGY SINUS

ADVIL ALLERGY SINUS is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ADVIL ALLERGY SINUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	ADVIL ALLERGY SINUS	chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	021441-001	Dec 19, 2002		OTC	Yes	Yes			Y

International Patents for ADVIL ALLERGY SINUS

See the table below for patents covering ADVIL ALLERGY SINUS around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	552030	Multi-layer tablet comprising non-steroidal anti-inflammatory drugs decongestants and non-sedating antihistamines
Japan	2008501692
Canada	2508611	COMPOSITIONS DE MEDICAMENTS ANTI-INFLAMMATOIRES NON-STEROIDAUX, DECONGESTIONNANTS ET ANTIHISTAMINIQUES (COMPOSITIONS OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS DECONGESTANTS AND ANTI-HISTAMINES)
World Intellectual Property Organization (WIPO)	2005120465
China	1726035	Compositions of non-steroidal anti-inflammatory drugs, decongestants and anti-histamines