Astepro Allergy is a drug owned by Bayer Healthcare Consumer Care. It is protected by 3 US drug patents filed in 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 04, 2028. Details of Astepro Allergy'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8518919 | Compositions comprising azelastine and methods of use thereof |
Nov, 2025
(1 year, 2 months from now) | Active |
| US9919050 | Compositions comprising azelastine |
Nov, 2025
(1 year, 2 months from now) | Active |
| US8071073 | Compositions comprising azelastine and methods of use thereof |
Jun, 2028
(3 years from now) | Active |
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 Astepro Allergy's patents.
Latest Legal Activities on Astepro Allergy's Patents
Given below is the list of recent legal activities going on the following patents of Astepro Allergy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 May, 2023 | US8071073 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Sep, 2021 | US9919050 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Feb, 2021 | US8518919 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 May, 2019 | US8071073 (Litigated) |
| Post Issue Communication - Certificate of Correction | 23 May, 2018 | US9919050 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Mar, 2018 | US9919050 |
| Recordation of Patent Grant Mailed Critical | 20 Mar, 2018 | US9919050 |
| Email Notification Critical | 01 Mar, 2018 | US9919050 |
| Issue Notification Mailed Critical | 28 Feb, 2018 | US9919050 |
| Dispatch to FDC | 07 Feb, 2018 | US9919050 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Astepro Allergy and ongoing litigations to help you estimate the early arrival of Astepro Allergy generic.
Astepro Allergy's Litigations
Astepro Allergy has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 07, 2014, against patent number US8071073. The petitioner Impax Laboratories, Inc., challenged the validity of this patent, with Meda Pharmaceuticals Inc. as the respondent. Click below to track the latest information on how companies are challenging Astepro Allergy's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8071073 | May, 2014 |
Terminated-Denied
(29 Jul, 2014) | Meda Pharmaceuticals Inc. | Impax Laboratories, Inc. |
US patents provide insights into the exclusivity only within the United States, but Astepro Allergy 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 Astepro Allergy's family patents as well as insights into ongoing legal events on those patents.
Astepro Allergy's Family Patents
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Generic Launch
Generic Release Date:
Astepro Allergy's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 04, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Astepro Allergy Generics:
Azelastine Hydrochloride is the generic name for the brand Astepro Allergy. 17 different companies have already filed for the generic of Astepro Allergy, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Astepro Allergy's generic
How can I launch a generic of Astepro Allergy before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Astepro Allergy's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Astepro Allergy'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 Astepro Allergy -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 205.5 mcg/spray | 12 Jul, 2021 | 1 | 04 Jun, 2028 | ||
| 205.5 mcg/spray | 12 Jul, 2021 | 1 | 04 Jun, 2028 |
Astepro Allergy Competitors
Understanding your competition is essential for market success. Astepro Allergy which is used for relieving allergy symptoms such as nasal congestion, runny nose, sneezing, and itchy nose., has several other brand drugs in the same treatment category and using the same active ingredient (Azelastine Hydrochloride). 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 | Treatment Area | ||
|---|---|---|---|---|
| Bayer Hlthcare |
| |||
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. Azelastine Hydrochloride. 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 Azelastine Hydrochloride, Astepro Allergy's active ingredient. Check the complete list of approved generic manufacturers for Astepro Allergy
About Astepro Allergy
Astepro Allergy is a drug owned by Bayer Healthcare Consumer Care. It is used for relieving allergy symptoms such as nasal congestion, runny nose, sneezing, and itchy nose. Astepro Allergy uses Azelastine Hydrochloride as an active ingredient. Astepro Allergy was launched by Bayer Hlthcare in 2021.
Approval Date:
Astepro Allergy was approved by FDA for market use on 17 June, 2021.
Active Ingredient:
Astepro Allergy uses Azelastine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Azelastine Hydrochloride ingredient
Treatment:
Astepro Allergy is used for relieving allergy symptoms such as nasal congestion, runny nose, sneezing, and itchy nose.
Dosage:
Astepro Allergy is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.2055MG/SPRAY | SPRAY, METERED | Over the counter | NASAL |