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Last Updated: July 13, 2024

ADVIL Drug Patent Profile


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When do Advil patents expire, and what generic alternatives are available?

Advil is a drug marketed by Haleon Us Holdings and is included in eleven NDAs. There are two patents protecting this drug.

The generic ingredient in ADVIL is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.

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Drug patent expirations by year for ADVIL
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Pharmacology for ADVIL

US Patents and Regulatory Information for ADVIL

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 ibuprofen TABLET;ORAL 018989-001 May 18, 1984 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings ADVIL CONGESTION RELIEF ibuprofen; phenylephrine hydrochloride TABLET;ORAL 022565-001 May 27, 2010 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings ADVIL ALLERGY SINUS chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 021441-001 Dec 19, 2002 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Haleon Us Holdings ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings ADVIL DUAL ACTION WITH ACETAMINOPHEN acetaminophen; ibuprofen TABLET;ORAL 211733-001 Feb 28, 2020 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Haleon Us Holdings ADVIL ibuprofen sodium TABLET;ORAL 201803-001 Jun 12, 2012 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ADVIL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Recordati Rare Diseases Pedea ibuprofen EMEA/H/C/000549
Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Authorised no no no 2004-07-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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