Extina is a drug owned by Norvium Bioscience Llc. 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 Oct 19, 2018. Details of Extina'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). | |||
| US7553835 | Topical antifungal composition |
Oct, 2018
(6 years ago) |
Expired
|
| US8026238 | Topical antifungal composition |
Oct, 2018
(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 Extina's patents.
Latest Legal Activities on Extina's Patents
Given below is the list of recent legal activities going on the following patents of Extina.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 30 Oct, 2023 | US8026238 |
| Maintenance Fee Reminder Mailed Critical | 15 May, 2023 | US8026238 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Mar, 2019 | US8026238 |
| Email Notification Critical | 14 Nov, 2016 | US8026238 |
| Change in Power of Attorney (May Include Associate POA) Critical | 14 Nov, 2016 | US8026238 |
| Correspondence Address Change Critical | 10 Nov, 2016 | US8026238 |
| Email Notification Critical | 01 Oct, 2013 | US8026238 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Oct, 2013 | US8026238 |
| Correspondence Address Change Critical | 30 Sep, 2013 | US8026238 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Sep, 2011 | US8026238 |
US patents provide insights into the exclusivity only within the United States, but Extina 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 Extina's family patents as well as insights into ongoing legal events on those patents.
Extina's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Extina's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 19, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Extina Generic API suppliers:
Ketoconazole is the generic name for the brand Extina. 17 different companies have already filed for the generic of Extina, with Teva having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Extina's generic
How can I launch a generic of Extina before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Extina's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Extina'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 Extina -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.02 | 30 Jul, 2009 | 1 | 25 Aug, 2011 | 19 Oct, 2018 | Eligible |
Alternative Brands for Extina
Extina which is used for treating seborrheic dermatitis and seborrhea in patients 12 years of age and older., has several other brand drugs using the same active ingredient (Ketoconazole). 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 | |
|---|---|---|
| Almirall |
| |
| Kramer |
| |
| Strongbridge |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ketoconazole, Extina's active ingredient. Check the complete list of approved generic manufacturers for Extina
About Extina
Extina is a drug owned by Norvium Bioscience Llc. It is used for treating seborrheic dermatitis and seborrhea in patients 12 years of age and older. Extina uses Ketoconazole as an active ingredient. Extina was launched by Norvium Bioscience in 2007.
Approval Date:
Extina was approved by FDA for market use on 12 June, 2007.
Active Ingredient:
Extina uses Ketoconazole as the active ingredient. Check out other Drugs and Companies using Ketoconazole ingredient
Treatment:
Extina is used for treating seborrheic dermatitis and seborrhea in patients 12 years of age and older.
Dosage:
Extina is available in aerosol, foam form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2% | AEROSOL, FOAM | Discontinued | TOPICAL |