Monistat 1 Combination Pack is a drug owned by Medtech Products Inc. 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 Nov 28, 2020. Details of Monistat 1 Combination Pack'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). | |||
| US5514698 | Antifungal vaginal cream composition |
Mar, 2014
(10 years ago) |
Expired
|
| US6153635 | Methods and kits for treating vulvovaginal candidiasis with miconazole nitrate |
Nov, 2020
(3 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Monistat 1 Combination Pack 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 Monistat 1 Combination Pack's family patents as well as insights into ongoing legal events on those patents.
Monistat 1 Combination Pack's Family Patents
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Generic Launch
Generic Release Date:
Monistat 1 Combination Pack's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 28, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Monistat 1 Combination Pack Generics:
Miconazole Nitrate is the generic name for the brand Monistat 1 Combination Pack. 10 different companies have already filed for the generic of Monistat 1 Combination Pack, with Cosette having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Monistat 1 Combination Pack's generic
How can I launch a generic of Monistat 1 Combination Pack before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Monistat 1 Combination Pack's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Monistat 1 Combination Pack'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 Monistat 1 Combination Pack -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2% and 1.2 g | 05 Dec, 2007 | 1 | 02 Jun, 2010 | 28 Nov, 2020 | Extinguished Deferred |
Monistat 1 Combination Pack Competitors
Understanding your competition is essential for market success. There are several other brand drugs using the same active ingredient (Miconazole Nitrate) as Monistat 1 Combination Pack. 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 | |
|---|---|---|
| Mylan |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Miconazole Nitrate, Monistat 1 Combination Pack's active ingredient. Check the complete list of approved generic manufacturers for Monistat 1 Combination Pack
About Monistat 1 Combination Pack
Monistat 1 Combination Pack is a drug owned by Medtech Products Inc. Monistat 1 Combination Pack uses Miconazole Nitrate as an active ingredient. Monistat 1 Combination Pack was launched by Medtech Products in 2001.
Approval Date:
Monistat 1 Combination Pack was approved by FDA for market use on 29 June, 2001.
Active Ingredient:
Monistat 1 Combination Pack uses Miconazole Nitrate as the active ingredient. Check out other Drugs and Companies using Miconazole Nitrate ingredient
Dosage:
Monistat 1 Combination Pack is available in cream, insert form for topical, vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2%,1.2GM | CREAM, INSERT | Over the counter | TOPICAL, VAGINAL |