Children's 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 Children's 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8071073 | Compositions comprising azelastine and methods of use thereof |
Jun, 2028
(3 years from now) | Active |
| US8518919 | Compositions comprising azelastine and methods of use thereof |
Nov, 2025
(11 months from now) | Active |
| US9919050 | Compositions comprising azelastine |
Nov, 2025
(11 months from now) | Active |
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 Children's Astepro Allergy and ongoing litigations to help you estimate the early arrival of Children's Astepro Allergy generic.
Children's Astepro Allergy's Litigations
Children's Astepro Allergy 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 Children's 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 Children's 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 Children's Astepro Allergy's family patents as well as insights into ongoing legal events on those patents.
Children's Astepro Allergy's Family Patents
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Generic Launch
Generic Release Date:
Children's 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)
Children's Astepro Allergy Generics:
There are no approved generic versions for Children's Astepro Allergy as of now.
How can I launch a generic of Children's Astepro Allergy before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Children's Astepro Allergy's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Children's 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 Children's 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 |
About Children's Astepro Allergy
Children'S 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. Children'S Astepro Allergy uses Azelastine Hydrochloride as an active ingredient. Children'S Astepro Allergy was launched by Bayer Hlthcare in 2021.
Approval Date:
Children's Astepro Allergy was approved by FDA for market use on 17 June, 2021.
Active Ingredient:
Children's Astepro Allergy uses Azelastine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Azelastine Hydrochloride ingredient
Treatment:
Children's Astepro Allergy is used for relieving allergy symptoms such as nasal congestion, runny nose, sneezing, and itchy nose.
Dosage:
Children's 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 |