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Last Updated: April 10, 2020

DrugPatentWatch Database Preview

ADVIL PM Drug Profile


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Which patents cover Advil Pm, and when can generic versions of Advil Pm launch?

Advil Pm is a drug marketed by Glaxosmithkline and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has twelve patent family members in ten countries.

The generic ingredient in ADVIL PM 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.

US ANDA Litigation and Generic Entry Outlook for Advil Pm

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for ADVIL PM
International Patents:12
US Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: 4
Bulk Api Vendors: 1
Formulation / Manufacturing:see details
DailyMed Link:ADVIL PM at DailyMed
Drug patent expirations by year for ADVIL PM
Synonyms for ADVIL PM
1357928-54-1
Diphenhydramine citrate / ibuprofen
Diphenhydramine citrate mixture with ibuprofen
LS-187933
Paragraph IV (Patent) Challenges for ADVIL PM
Tradename Dosage Ingredient NDA Submissiondate
ADVIL PM TABLET;ORAL diphenhydramine citrate; ibuprofen 021394 2017-12-28
ADVIL PM CAPSULE;ORAL diphenhydramine hydrochloride; ibuprofen 021393 2016-02-16

US Patents and Regulatory Information for ADVIL PM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline ADVIL PM diphenhydramine citrate; ibuprofen TABLET;ORAL 021394-001 Dec 21, 2005 OTC Yes Yes   Start Trial   Start Trial Y   Start 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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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Merck
McKesson
Johnson and Johnson
Dow

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