HALEON US HOLDINGS Company Profile

What is the competitive landscape for HALEON US HOLDINGS, and what generic alternatives to HALEON US HOLDINGS drugs are available?

HALEON US HOLDINGS has thirty-one approved drugs.

There are nine US patents protecting HALEON US HOLDINGS drugs.

There are one hundred and ninety-one patent family members on HALEON US HOLDINGS drugs in thirty-two countries and sixteen supplementary protection certificates in eight countries.

Summary for HALEON US HOLDINGS

International Patents:	191
US Patents:	9
Tradenames:	28
Ingredients:	18
NDAs:	31

Drugs and US Patents for HALEON US HOLDINGS

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 CONGESTION RELIEF	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022565-001	May 27, 2010		OTC	Yes	Yes
Haleon Us Holdings	ADVIL MIGRAINE LIQUI-GELS	ibuprofen	CAPSULE;ORAL	020402-002	Mar 16, 2000		OTC	Yes	Yes
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802-001	Jan 14, 1998		OTC	Yes	Yes
Haleon Us Holdings	PEDIATRIC ADVIL	ibuprofen	SUSPENSION/DROPS;ORAL	020812-001	Jan 30, 1998		DISCN	Yes	No
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-002	Oct 31, 2002		OTC	Yes	Yes
Haleon Us Holdings	CHILDREN'S ADVIL COLD	ibuprofen; pseudoephedrine hydrochloride	SUSPENSION;ORAL	021373-001	Apr 18, 2002		OTC	No	No
Haleon Us Holdings	ADVIL ALLERGY SINUS	chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	021441-001	Dec 19, 2002		OTC	Yes	Yes	7,863,287		Y

Expired US Patents for HALEON US HOLDINGS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007	4,598,089
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802-001	Jan 14, 1998	5,972,916
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802-001	Jan 14, 1998	4,943,565
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005	8,883,849
Haleon Us Holdings	CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	020589-001	Jun 27, 1996	4,788,220*PED
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002	5,071,643*PED
Haleon Us Holdings	ADVIL CONGESTION RELIEF	ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022565-001	May 27, 2010	5,087,454

Paragraph IV (Patent) Challenges for HALEON US HOLDINGS drugs

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

International Patents for HALEON US HOLDINGS Drugs

Country	Patent Number	Estimated Expiration
Australia	2005221876
Hong Kong	1078494
World Intellectual Property Organization (WIPO)	2006124366
Denmark	1723052
China	1988893
Mexico	PA05006331
World Intellectual Property Organization (WIPO)	03095006

Supplementary Protection Certificates for HALEON US HOLDINGS Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
2506844	LUC00077	Luxembourg		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
1519731	132013902182575	Italy		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	1890025-8	Sweden		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
0129748	98C0042	Belgium		PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Haleon Us Holdings