Megace Es is a drug owned by Endo Operations Ltd. It is protected by 6 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 22, 2024. Details of Megace Es'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). | |||
| US7101576 | Nanoparticulate megestrol formulations |
Apr, 2024
(2 years ago) |
Expired
|
| US9101540 | Nanoparticulate megestrol formulations |
Apr, 2024
(2 years ago) |
Expired
|
| US9040088 | Nanoparticulate megestrol formulations |
Apr, 2024
(2 years ago) |
Expired
|
| US9101549 | Nanoparticulate megestrol formulations |
Apr, 2024
(2 years ago) |
Expired
|
| US9107827 | Nanoparticulate megestrol formulations |
Apr, 2024
(2 years ago) |
Expired
|
| US6592903 | Nanoparticulate dispersions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate |
Sep, 2020
(6 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 Megace Es's patents.
Latest Legal Activities on Megace Es's Patents
Given below is the list of recent legal activities going on the following patents of Megace Es.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Feb, 2023 | US9107827 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Feb, 2023 | US9101540 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Feb, 2023 | US9101549 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Nov, 2022 | US9040088 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Feb, 2019 | US9107827 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Feb, 2019 | US9101540 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Feb, 2019 | US9101549 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Nov, 2018 | US9040088 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Mar, 2018 | US7101576 (Litigated) |
| Application ready for PDX access by participating foreign offices
Critical | 31 Aug, 2015 | US9040088 |
US patents provide insights into the exclusivity only within the United States, but
Megace Es 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 Megace Es's family patents as well as insights into
ongoing legal events
on those patents.
Megace Es's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Megace Es:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Megace Es's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 22, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Megace Es Generic API suppliers:
Megestrol Acetate is the generic name for the brand Megace Es. 10 different companies have already filed for the generic of Megace Es, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Megace Es's generic
How can I launch a generic of Megace Es before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Megace Es's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Megace Es'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 Megace Es -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 27 Apr, 2011 | 22 Apr, 2024 | Eligible | 27 Aug, 2014 | Less |
About Megace Es
Megace Es is a drug owned by Endo Operations Ltd. It is used for treating anorexia, cachexia, or unexplained significant weight loss in AIDS patients. Megace Es uses Megestrol Acetate as an active ingredient. Megace Es was launched by Endo Operations in 2005.
Approval Date:
Megace Es was approved by FDA for market use on 05 July, 2005.
Active Ingredient:
Megace Es uses Megestrol Acetate as the active ingredient. Check out other Drugs and Companies using Megestrol Acetate ingredient
Treatment:
Megace Es is used for treating anorexia, cachexia, or unexplained significant weight loss in AIDS patients.
Dosage:
Megace Es is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 125MG/ML | SUSPENSION | Discontinued | ORAL |