Azasite is a drug owned by Thea Pharma Inc. It is protected by 5 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 Mar 31, 2019. Details of Azasite'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). | |||
| US7056893 | Topical treatment for prevention of ocular infections |
Mar, 2019
(7 years ago) |
Expired
|
| US6239113 | Topical treatment or prevention of ocular infections |
Mar, 2019
(7 years ago) |
Expired
|
| US6569443 | Topical treatment or prevention of ocular infections |
Mar, 2019
(7 years ago) |
Expired
|
| US6861411 | Method of treating eye infections with azithromycin |
Nov, 2018
(7 years ago) |
Expired
|
| US6159458 | Sustained release ophthalmic compositions containing water soluble medicaments |
Nov, 2017
(8 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 Azasite's patents.
Latest Legal Activities on Azasite's Patents
Given below is the list of recent legal activities going on the following patents of Azasite.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Nov, 2017 | US7056893 (Litigated) |
| Mail Interference Decision - Favorable | 25 Nov, 2011 | US6569443 (Litigated) |
| Interference Decision on Priority - Favorable | 25 Nov, 2011 | US6569443 (Litigated) |
| Declaration of Interference | 30 Nov, 2009 | US6569443 (Litigated) |
| Change in Power of Attorney (May Include Associate POA)
Critical | 20 Jun, 2006 | US7056893 (Litigated) |
| Correspondence Address Change
Critical | 20 Jun, 2006 | US7056893 (Litigated) |
| Recordation of Patent Grant Mailed
Critical | 06 Jun, 2006 | US7056893 (Litigated) |
| Patent Issue Date Used in PTA Calculation
Critical | 06 Jun, 2006 | US7056893 (Litigated) |
| Issue Notification Mailed
Critical | 17 May, 2006 | US7056893 (Litigated) |
| Application Is Considered Ready for Issue
Critical | 16 May, 2006 | US7056893 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but
Azasite 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 Azasite's family patents as well as insights into
ongoing legal events
on those patents.
Azasite's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Azasite:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Azasite's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 31, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Azasite Generic API suppliers:
Azithromycin is the generic name for the brand Azasite. 31 different companies have already filed for the generic of Azasite, with Pliva having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Azasite's generic
How can I launch a generic of Azasite before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Azasite's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Azasite'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 Azasite -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 03 Mar, 2011 | 31 Mar, 2019 | Extinguished | Less |
Alternative Brands for Azasite
Azasite which is used for treating bacterial infections., has several other brand drugs in the same treatment category and using the same active ingredient (Azithromycin). 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. Azithromycin. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Azithromycin, Azasite's active ingredient. Check the complete list of approved generic manufacturers for Azasite
About Azasite
Azasite is a drug owned by Thea Pharma Inc. It is used for treating bacterial infections. Azasite uses Azithromycin as an active ingredient. Azasite was launched by Thea in 2007.
Approval Date:
Azasite was approved by FDA for market use on 27 April, 2007.
Active Ingredient:
Azasite uses Azithromycin as the active ingredient. Check out other Drugs and Companies using Azithromycin ingredient
Treatment:
Azasite is used for treating bacterial infections.
Dosage:
Azasite is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1% | SOLUTION/DROPS | Prescription | OPHTHALMIC |