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Last Updated: September 25, 2022

ADVIL PM Drug Patent 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.

DrugPatentWatch® Generic Entry Outlook for Advil Pm

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ADVIL PM
Paragraph IV (Patent) Challenges for ADVIL PM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ADVIL PM Tablets diphenhydramine citrate; ibuprofen 200 mg/38 mg 021394 1 2017-12-28
ADVIL PM Capsules diphenhydramine hydrochloride; ibuprofen 200 mg/25 mg 021393 2016-02-16

US Patents and Regulatory Information for ADVIL PM

ADVIL PM is protected by three US patents.

Patents protecting ADVIL PM

Treatment of sleep disturbances
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatment of sleep disturbances
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING A PATIENT SUFFERING FROM A PAIN ASSOCIATED SLEEP DISTURBANCE COMPRISING ADMINISTERING A LIQUID COMPOSITION FORMULATED INSIDE A SOFT GEL CAPSULE, AS CLAIMED, TO THE PATIENT

Treatment of sleep disturbances
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 OTC Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline ADVIL PM diphenhydramine citrate; ibuprofen TABLET;ORAL 021394-001 Dec 21, 2005 OTC Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 ADVIL PM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 See Plans and Pricing See Plans and Pricing
Glaxosmithkline ADVIL PM diphenhydramine citrate; ibuprofen TABLET;ORAL 021394-001 Dec 21, 2005 See Plans and Pricing See Plans and Pricing
Glaxosmithkline ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Merck
McKesson
Johnson and Johnson
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.