Haleon Us Holdings Company Profile

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.

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

Summary for Haleon Us Holdings

International Patents:	196
US Patents:	8
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	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes	8,347,879		Y
Haleon Us Holdings	TAVIST-1	clemastine fumarate	TABLET;ORAL	020925-001	Aug 21, 1992		DISCN	Yes	No
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes	8,147,461		Y
Haleon Us Holdings	CHILDREN'S ADVIL ALLERGY SINUS	chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride	SUSPENSION;ORAL	021587-001	Feb 24, 2004		OTC	Yes	Yes
Haleon Us Holdings	AXID AR	nizatidine	TABLET;ORAL	020555-001	May 9, 1996		OTC	Yes	Yes
Haleon Us Holdings	CHILDREN'S ADVIL	ibuprofen	TABLET, CHEWABLE;ORAL	020944-001	Dec 18, 1998		OTC	No	No

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	6,004,996
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016	8,752,543
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941-001	Jul 25, 2000	5,534,554
Haleon Us Holdings	NICORETTE	nicotine polacrilex	TROCHE/LOZENGE;ORAL	021330-001	Oct 31, 2002	5,110,605
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005	8,883,849
Haleon Us Holdings	AXID AR	nizatidine	TABLET;ORAL	020555-001	May 9, 1996	4,375,547

Paragraph IV (Patent) Challenges for HALEON US HOLDINGS drugs

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

International Patents for Haleon Us Holdings Drugs

Country	Patent Number	Estimated Expiration
South Africa	200708545
Mexico	PA05000821
Spain	2516650
Australia	2006235671
New Zealand	540289
Philippines	12021553169

Supplementary Protection Certificates for Haleon Us Holdings Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
0428642	57/2007	Austria		PRODUCT NAME: DOCOSANOL; NAT. REGISTRATION NO/DATE: 1-27014 20070518; FIRST REGISTRATION: SE 18517 20031114
2506844	132018000000341	Italy		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	SPC/GB18/020	United Kingdom		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
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726

Similar Applicant Names

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Here is a list of applicants with similar names.

• Haleon Us Holdings