Haleon Us Holdings Company Profile

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HALEON US HOLDINGS has thirty-one approved drugs.

There are ten US patents protecting HALEON US HOLDINGS drugs.

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

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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	NICORETTE	nicotine polacrilex	GUM, CHEWING;BUCCAL	020066-002	Feb 9, 1996		OTC	Yes	Yes	8,323,683	⤷ Sign Up	Y			⤷ Sign Up
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009		OTC	Yes	No	8,940,772	⤷ Sign Up	Y			⤷ Sign Up
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002		OTC	Yes	No		⤷ Sign Up				⤷ Sign Up
Haleon Us Holdings	NICORETTE	nicotine polacrilex	GUM, CHEWING;BUCCAL	018612-004	Sep 25, 2000		OTC	Yes	No		⤷ Sign Up				⤷ Sign Up
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009		OTC	Yes	No	8,501,164	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-002	Oct 31, 2002	5,110,605	⤷ Sign Up
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016	9,320,862	⤷ Sign Up
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002	5,110,605	⤷ Sign Up
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016	7,541,350	⤷ Sign Up
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002	5,071,643*PED	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Capsules	200 mg/38 mg	➤ Subscribe	2016-02-16
➤ Subscribe	Gum	2 mg	➤ Subscribe	2013-01-22

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005044354	⤷ Sign Up
World Intellectual Property Organization (WIPO)	03095007	⤷ Sign Up
Taiwan	200719915	⤷ Sign Up
Mexico	PA05000821	⤷ Sign Up
Norway	336083	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	2018C/022	Belgium	⤷ Sign Up	PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
2506844	LUC00077	Luxembourg	⤷ Sign Up	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
0428642	07C0081	France	⤷ Sign Up	PRODUCT NAME: DOCOSANOL; REGISTRATION NO/DATE IN FRANCE: NL 33457 DU 20070821; REGISTRATION NO/DATE AT EEC: 18517 DU 20031114
1519731	13C0067	France	⤷ Sign Up	PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
0129748	98C0042	Belgium	⤷ Sign Up	PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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