Metrogel is a drug owned by Galderma Laboratories Lp. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 21, 2022. Details of Metrogel'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). | |||
| US6881726 | Aqueous compositions containing metronidazole |
Feb, 2022
(2 years ago) |
Expired
|
| US7348317 | Aqueous compositions containing metronidazole |
Feb, 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 Metrogel's patents.
Latest Legal Activities on Metrogel's Patents
Given below is the list of recent legal activities going on the following patents of Metrogel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Aug, 2019 | US7348317 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 25 Mar, 2008 | US7348317 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 25 Mar, 2008 | US7348317 (Litigated) |
| Issue Notification Mailed Critical | 05 Mar, 2008 | US7348317 (Litigated) |
| Dispatch to FDC | 22 Feb, 2008 | US7348317 (Litigated) |
| Application Is Considered Ready for Issue Critical | 22 Feb, 2008 | US7348317 (Litigated) |
| Issue Fee Payment Received Critical | 16 Jan, 2008 | US7348317 (Litigated) |
| Issue Fee Payment Verified Critical | 16 Jan, 2008 | US7348317 (Litigated) |
| Mail Notice of Allowance Critical | 14 Jan, 2008 | US7348317 (Litigated) |
| Notice of Allowance Data Verification Completed Critical | 10 Jan, 2008 | US7348317 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Metrogel 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 Metrogel's family patents as well as insights into ongoing legal events on those patents.
Metrogel's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Metrogel's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 21, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Metrogel Generic API suppliers:
Metronidazole is the generic name for the brand Metrogel. 38 different companies have already filed for the generic of Metrogel, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Metrogel's generic
How can I launch a generic of Metrogel before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Metrogel's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Metrogel'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 Metrogel -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.01 | 21 Oct, 2008 | 1 | 22 Jul, 2011 | 21 Feb, 2022 | Eligible |
Alternative Brands for Metrogel
Metrogel which is used for treating inflammatory lesions of rosacea., has several other brand drugs using the same active ingredient (Metronidazole). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Bausch |
| |
| Chemo Research Sl |
| |
| Labs Juvise |
| |
| Pfizer |
| |
| Saptalis Pharms |
| |
| Teva Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Metronidazole, Metrogel's active ingredient. Check the complete list of approved generic manufacturers for Metrogel
About Metrogel
Metrogel is a drug owned by Galderma Laboratories Lp. It is used for treating inflammatory lesions of rosacea. Metrogel uses Metronidazole as an active ingredient. Metrogel was launched by Galderma Labs Lp in 2005.
Approval Date:
Metrogel was approved by FDA for market use on 30 June, 2005.
Active Ingredient:
Metrogel uses Metronidazole as the active ingredient. Check out other Drugs and Companies using Metronidazole ingredient
Treatment:
Metrogel is used for treating inflammatory lesions of rosacea.
Dosage:
Metrogel is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1% | GEL | Prescription | TOPICAL |