Metrogel-vaginal is a drug owned by Bausch Health Us 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 Jul 16, 2013. Details of Metrogel-vaginal'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). | |||
| US5536743 | Intravaginal treatment of vaginal infections with buffered metronidazole compositions |
Jul, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Metrogel-vaginal 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-vaginal's family patents as well as insights into ongoing legal events on those patents.
Metrogel-vaginal's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Metrogel-vaginal's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 16, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Metrogel-vaginal Generic API suppliers:
Metronidazole is the generic name for the brand Metrogel-vaginal. 38 different companies have already filed for the generic of Metrogel-vaginal, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Metrogel-vaginal's generic
How can I launch a generic of Metrogel-vaginal before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Metrogel-vaginal's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Metrogel-vaginal'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-vaginal -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0075 | 02 Sep, 2004 | 1 | 06 Jun, 2006 | Extinguished |
Alternative Brands for Metrogel-vaginal
Metrogel-vaginal which is used for treating bacterial vaginosis., has several other brand drugs in the same treatment category and 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.
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Metronidazole. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Chemo Research Sl |
| |
| Galderma Labs Lp |
| |
| Labs Juvise |
| |
| Saptalis Pharms |
| |
| Teva Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Metronidazole, Metrogel-vaginal's active ingredient. Check the complete list of approved generic manufacturers for Metrogel-vaginal
About Metrogel-vaginal
Metrogel-Vaginal is a drug owned by Bausch Health Us Llc. It is used for treating bacterial vaginosis. Metrogel-Vaginal uses Metronidazole as an active ingredient. Metrogel-Vaginal was launched by Bausch in 1992.
Approval Date:
Metrogel-vaginal was approved by FDA for market use on 17 August, 1992.
Active Ingredient:
Metrogel-vaginal uses Metronidazole as the active ingredient. Check out other Drugs and Companies using Metronidazole ingredient
Treatment:
Metrogel-vaginal is used for treating bacterial vaginosis.
Dosage:
Metrogel-vaginal is available in gel form for vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.75% | GEL | Prescription | VAGINAL |