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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8263647 | Treatment of sleep disturbances |
May, 2022
(2 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Advil Pm's patents.
Latest Legal Activities on Advil Pm's Patents
Given below is the list of recent legal activities going on the following patents of Advil Pm.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 29 Apr, 2024 | US8263647 |
| Expire Patent Critical | 20 Nov, 2023 | US9155718 |
| Maintenance Fee Reminder Mailed Critical | 05 Jun, 2023 | US9155718 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Apr, 2022 | US8883849 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Feb, 2020 | US8263647 |
| Correspondence Address Change Critical | 05 Nov, 2019 | US8263647 |
| Correspondence Address Change Critical | 05 Nov, 2019 | US8883849 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Mar, 2019 | US9155718 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Apr, 2018 | US8883849 |
| Recordation of Patent Grant Mailed Critical | 13 Oct, 2015 | US9155718 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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.
Approval 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 |
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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8883849 | Treatment of sleep disturbances |
Jan, 2022
(3 years ago) |
Expired
|
| US9155718 | Treatment of sleep disturbances |
Jan, 2022
(3 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Advil Pm's patents.
Latest Legal Activities on Advil Pm's Patents
Given below is the list of recent legal activities going on the following patents of Advil Pm.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Maintenance Fee Reminder Mailed Critical | 29 Apr, 2024 | US8263647 |
| Expire Patent Critical | 20 Nov, 2023 | US9155718 |
| Maintenance Fee Reminder Mailed Critical | 05 Jun, 2023 | US9155718 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Apr, 2022 | US8883849 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Feb, 2020 | US8263647 |
| Correspondence Address Change Critical | 05 Nov, 2019 | US8263647 |
| Correspondence Address Change Critical | 05 Nov, 2019 | US8883849 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Mar, 2019 | US9155718 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Apr, 2018 | US8883849 |
| Recordation of Patent Grant Mailed Critical | 13 Oct, 2015 | US9155718 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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.
Approval 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 |