Last Updated: November 13, 2026

Haleon Us Holdings Company Profile

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What is the competitive landscape for HALEON US HOLDINGS

HALEON US HOLDINGS has thirty-one approved drugs.

There are eight US patents protecting HALEON US HOLDINGS drugs.

Summary for Haleon Us Holdings

US Patents:	8
Tradenames:	28
Ingredients:	18
NDAs:	31

Drugs and US Patents for Haleon Us Holdings

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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 COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	019771-001	Sep 19, 1989		OTC	Yes	Yes		⤷ Start Trial				⤷ Start Trial
Haleon Us Holdings	ADVIL MULTI-SYMPTOM COLD & FLU	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022113-002	Apr 28, 2017		OTC	Yes	Yes		⤷ Start Trial				⤷ Start Trial
Haleon Us Holdings	JUNIOR STRENGTH ADVIL	ibuprofen	TABLET, CHEWABLE;ORAL	020944-002	Dec 18, 1998		OTC	No	No		⤷ Start Trial				⤷ Start Trial
Haleon Us Holdings	CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	019833-002	Sep 19, 1989		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Haleon Us Holdings	NICORETTE	nicotine polacrilex	GUM, CHEWING;BUCCAL	020066-004	Sep 25, 2000		OTC	Yes	No		⤷ Start Trial				⤷ Start Trial
Haleon Us Holdings	NICORETTE (MINT)	nicotine polacrilex	GUM, CHEWING;BUCCAL	018612-003	Dec 23, 1998		OTC	Yes	No		⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for Haleon Us Holdings

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016	6,858,596	⤷ Start Trial
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802-001	Jan 14, 1998	5,972,916	⤷ Start Trial
Haleon Us Holdings	CHILDREN'S ADVIL-FLAVORED	ibuprofen	SUSPENSION;ORAL	020589-002	Nov 7, 1997	10,238,640	⤷ Start Trial
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002	5,110,605	⤷ Start Trial
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005	8,883,849	⤷ Start Trial
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007	6,004,996	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Paragraph IV (Patent) Challenges for HALEON US HOLDINGS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Capsules	200 mg/38 mg	➤ Subscribe	2016-02-16
➤ Subscribe	Gum	2 mg	➤ Subscribe	2013-01-22
➤ Subscribe	Capsules	200 mg/30 mg	➤ Subscribe	2004-12-27
➤ Subscribe	Capsules	60 mg	➤ Subscribe	2010-09-08
➤ Subscribe	Gum	4 mg	➤ Subscribe	2013-01-22

International Patents for Haleon Us Holdings Drugs

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Country	Patent Number	Estimated Expiration
Canada	2608531	⤷ Start Trial
Japan	5068250	⤷ Start Trial
Russian Federation	2429827	⤷ Start Trial
China	101596335	⤷ Start Trial
Australia	2009243065	⤷ Start Trial
Brazil	0312230	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for Haleon Us Holdings Drugs

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	132013902182575	Italy	⤷ Start Trial	PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
2506844	132018000000341	Italy	⤷ Start Trial	PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
2506844	1890025-8	Sweden	⤷ Start Trial	PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
2506844	LUC00077	Luxembourg	⤷ Start Trial	PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
0129748	SPC/GB98/044	United Kingdom	⤷ Start Trial	PRODUCT NAME: ORLISTAT; REGISTERED: UK EU/1/98/071/001 19980729; UK EU/1/98/071/002 19980729; UK EU/1/98/071/003 19980729; UK EO/1/98/071/004 19980729; UK EU/1/98/071/005 19980729; UK EU/1/98/071/006 19980729
2506844	SPC/GB18/020	United Kingdom	⤷ Start Trial	PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Similar Applicant Names

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Here is a list of applicants with similar names.

Haleon Us Holdings

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.