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Last Updated: February 7, 2025

Haleon Us Holdings Company Profile


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Summary for Haleon Us Holdings
International Patents:203
US Patents:10
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 COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 019771-001 Sep 19, 1989 OTC Yes Yes ⤷  Free Trial ⤷  Free Trial
Haleon Us Holdings ADVIL ALLERGY SINUS chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 021441-001 Dec 19, 2002 OTC Yes Yes 7,863,287 ⤷  Free Trial Y ⤷  Free Trial
Haleon Us Holdings AXID AR nizatidine TABLET;ORAL 020555-001 May 9, 1996 OTC Yes Yes ⤷  Free Trial ⤷  Free Trial
Haleon Us Holdings ADVIL ALLERGY AND CONGESTION RELIEF chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride TABLET;ORAL 022113-001 Dec 21, 2011 OTC Yes Yes ⤷  Free Trial ⤷  Free 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 CHILDREN'S ADVIL ALLERGY SINUS chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 021587-001 Feb 24, 2004 10,238,640 ⤷  Free Trial
Haleon Us Holdings ADVIL PM diphenhydramine citrate; ibuprofen TABLET;ORAL 021394-001 Dec 21, 2005 8,263,647 ⤷  Free Trial
Haleon Us Holdings ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 021374-001 May 30, 2002 5,071,643*PED ⤷  Free Trial
Haleon Us Holdings ABREVA docosanol CREAM;TOPICAL 020941-001 Jul 25, 2000 5,534,554 ⤷  Free 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
1519731 13C0067 France ⤷  Free 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
1519731 92269 Luxembourg ⤷  Free Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844 132018000000341 Italy ⤷  Free 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 ⤷  Free 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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