Butoconazole Nitrate is a drug owned by Padagis 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 Nov 17, 2017. Details of Butoconazole Nitrate'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). | |||
| US5993856 | Pharmaceutical preparations and methods for their administration |
Nov, 2017
(7 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Butoconazole Nitrate 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 Butoconazole Nitrate's family patents as well as insights into ongoing legal events on those patents.
Butoconazole Nitrate's Family Patents
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Generic Launch
Generic Release Date:
Butoconazole Nitrate's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 17, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Butoconazole Nitrate Generic API suppliers:
Butoconazole Nitrate is the generic name for the brand Butoconazole Nitrate. 1 company has already filed for the generic of Butoconazole Nitrate. Check out the entire list of companies who have already received approval for Butoconazole Nitrate's generic
How can I launch a generic of Butoconazole Nitrate before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Butoconazole Nitrate's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Butoconazole Nitrate'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 Butoconazole Nitrate -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.02 | 23 Dec, 2009 | 1 | 18 May, 2012 | 17 Nov, 2017 | Eligible |
About Butoconazole Nitrate
Butoconazole Nitrate is a drug owned by Padagis Us Llc. It is used for treating vaginal fungal infections in females. Butoconazole Nitrate uses Butoconazole Nitrate as an active ingredient. Butoconazole Nitrate was launched by Padagis Us in 1997.
Approval Date:
Butoconazole Nitrate was approved by FDA for market use on 07 February, 1997.
Active Ingredient:
Butoconazole Nitrate uses Butoconazole Nitrate as the active ingredient. Check out other Drugs and Companies using Butoconazole Nitrate ingredient
Treatment:
Butoconazole Nitrate is used for treating vaginal fungal infections in females.
Dosage:
Butoconazole Nitrate is available in cream form for vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2% | CREAM | Discontinued | VAGINAL |