Last Updated: August 2, 2026

Haleon Us Holdings Company Profile


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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 ADVIL LIQUI-GELS ibuprofen CAPSULE;ORAL 020402-001 Apr 20, 1995 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial
Haleon Us Holdings NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No 8,940,772 ⤷  Start Trial Y ⤷  Start Trial
Haleon Us Holdings TAVIST-1 clemastine fumarate TABLET;ORAL 020925-001 Aug 21, 1992 DISCN 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
Haleon Us Holdings FLONASE ALLERGY RELIEF fluticasone propionate SPRAY, METERED;NASAL 205434-001 Jul 23, 2014 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Haleon Us Holdings NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 5,110,605 ⤷  Start Trial
Haleon Us Holdings ABREVA docosanol CREAM;TOPICAL 020941-001 Jul 25, 2000 5,534,554 ⤷  Start Trial
Haleon Us Holdings AXID AR nizatidine TABLET;ORAL 020555-001 May 9, 1996 4,375,547 ⤷  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 FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051-002 Aug 2, 2016 7,541,350 ⤷  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/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

Supplementary Protection Certificates for Haleon Us Holdings Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0129748 98C0042 Belgium ⤷  Start Trial PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
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
1781277 PA2024501 Lithuania ⤷  Start Trial PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726
1519731 13C0067 France ⤷  Start Trial 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
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
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