Advil Pm Patent Expiration

Advil Pm is a drug owned by Haleon Us Holdings Llc. It is protected by 2 US drug patents filed from 2014 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 17, 2022. Details of Advil Pm's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8883849 Treatment of sleep disturbances
Jan, 2022

(2 years ago)

Expired
US9155718 Treatment of sleep disturbances
Jan, 2022

(2 years ago)

Expired

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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US patents provide insights into the exclusivity only within the United States, but Advil Pm is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Advil Pm's family patents as well as insights into ongoing legal events on those patents.

Advil Pm's family patents

Advil Pm has patent protection in a total of 10 countries. It's US patent count contributes only to 37.5% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Advil Pm.

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Generic Launch

Generic Release Date:

Advil Pm's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 17, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Advil Pm Generics:

Diphenhydramine Hydrochloride; Ibuprofen is the generic name for the brand Advil Pm. 4 different companies have already filed for the generic of Advil Pm, with Aurobindo Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Advil Pm's generic

How can I launch a generic of Advil Pm before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Advil Pm's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Advil Pm's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Advil Pm -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
200 mg/25 mg 16 Feb, 2016




About Advil Pm

Advil Pm is a drug owned by Haleon Us Holdings Llc. It is used for treating pain-associated sleep disturbances. Advil Pm uses Diphenhydramine Hydrochloride; Ibuprofen as an active ingredient. Advil Pm was launched by Haleon Us Holdings in 2005.

Market Authorisation Date:

Advil Pm was approved by FDA for market use on 21 December, 2005.

Active Ingredient:

Advil Pm uses Diphenhydramine Hydrochloride; Ibuprofen as the active ingredient. Check out other Drugs and Companies using Diphenhydramine Hydrochloride; Ibuprofen ingredient

Treatment:

Advil Pm is used for treating pain-associated sleep disturbances.

Dosage:

Advil Pm is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE Over the counter ORAL


Advil Pm is a drug owned by Haleon Us Holdings Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 30, 2022. Details of Advil Pm's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8263647 Treatment of sleep disturbances
May, 2022

(2 years ago)

Expired

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Advil Pm is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Advil Pm's family patents as well as insights into ongoing legal events on those patents.

Advil Pm's family patents

Advil Pm has patent protection in a total of 10 countries. It's US patent count contributes only to 37.5% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Advil Pm.

Family Patents

Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

Thank you for your response 🥳



Generic Launch

Generic Release Date:

Advil Pm's generic launch date based on the expiry of its last outstanding patent is estimated to be May 30, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Advil Pm Generics:

Diphenhydramine Citrate; Ibuprofen is the generic name for the brand Advil Pm. 4 different companies have already filed for the generic of Advil Pm, with Aurobindo Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Advil Pm's generic

How can I launch a generic of Advil Pm before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Advil Pm's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Advil Pm's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Advil Pm -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
200 mg/38 mg 28 Dec, 2017 1 30 May, 2022 Extinguished




About Advil Pm

Advil Pm is a drug owned by Haleon Us Holdings Llc. It is used for treating pain-associated sleep disturbances. Advil Pm uses Diphenhydramine Citrate; Ibuprofen as an active ingredient. Advil Pm was launched by Haleon Us Holdings in 2005.

Market Authorisation Date:

Advil Pm was approved by FDA for market use on 21 December, 2005.

Active Ingredient:

Advil Pm uses Diphenhydramine Citrate; Ibuprofen as the active ingredient. Check out other Drugs and Companies using Diphenhydramine Citrate; Ibuprofen ingredient

Treatment:

Advil Pm is used for treating pain-associated sleep disturbances.

Dosage:

Advil Pm is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
38MG;200MG TABLET Over the counter ORAL