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	TROCHE/LOZENGE;ORAL	022360-001	May 18, 2009		OTC	Yes	No	8,501,164	⤷ Try a Trial	Y			⤷ Try a Trial
Haleon Us Holdings	TAVIST-1	clemastine fumarate	TABLET;ORAL	020925-001	Aug 21, 1992		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Haleon Us Holdings	ADVIL MIGRAINE LIQUI-GELS	ibuprofen	CAPSULE;ORAL	020402-002	Mar 16, 2000		OTC	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
>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	FLONASE	fluticasone propionate	SPRAY, METERED;NASAL	020121-001	Oct 19, 1994	4,335,121*PED	⤷ Try a Trial
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005	8,263,647	⤷ Try a Trial
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005	8,883,849	⤷ Try a Trial
>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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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	08C0014	France	⤷ Try a Trial	PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
2506844	132018000000341	Italy	⤷ Try a 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
1519731	132013902182575	Italy	⤷ Try a 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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