Children's Astepro Allergy Patent Expiration

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

(1 year, 6 days from now)

Active
US9919050 Compositions comprising azelastine
Nov, 2025

(1 year, 6 days 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.

Last updated on November 12, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8071073 May, 2014 Terminated-Denied
(29 Jul, 2014)
Meda Pharmaceuticals Inc. Impax Laboratories, Inc.

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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

Children's Astepro Allergy has patent protection in a total of 24 countries. It's US patent count contributes only to 16.4% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Children's Astepro Allergy.

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