Astepro Patent Expiration

Astepro is a drug owned by Mylan Specialty Lp. It is protected by 3 US drug patents filed from 2013 to 2018 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'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, 4 months from now)

Active
US9919050 Compositions comprising azelastine
Nov, 2025

(1 year, 4 months from now)

Active
US8071073 Compositions comprising azelastine and methods of use thereof
Jun, 2028

(3 years 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 Astepro and ongoing litigations to help you estimate the early arrival of Astepro generic.

Astepro's Litigations

Astepro 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 or infringement of this patent, with Meda Pharmaceuticals Inc. as the respondent. Click below to track the latest information on how companies are challenging Astepro's patents.


Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8071073 May, 2014 Terminated-Denied Meda Pharmaceuticals Inc. Impax Laboratories, Inc.


FDA has granted some exclusivities to Astepro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Astepro, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Astepro.

Exclusivity Information

Astepro holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Astepro's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Oct 15, 2011
M(M-129) Aug 30, 2016
New Patient Population(NPP) Feb 20, 2018

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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US patents provide insights into the exclusivity only within the United States, but Astepro 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's family patents as well as insights into ongoing legal events on those patents.

Astepro's family patents

Astepro 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 Astepro.

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Generic Launch

Generic Release Date:

Astepro's generic launch date based on the last expiry date of its patents and exclusivities combined 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 Generics:

Azelastine Hydrochloride is the generic name for the brand Astepro. 17 different companies have already filed for the generic of Astepro, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Astepro's generic

How can I launch a generic of Astepro before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Astepro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Astepro'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 -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
205.5 mcg/spray 15 Dec, 2011




About Astepro

Astepro is a drug owned by Mylan Specialty Lp. It is used for treating allergic rhinitis. Astepro uses Azelastine Hydrochloride as an active ingredient. Astepro was launched by Mylan Speciality Lp in 2008.

Market Authorisation Date:

Astepro was approved by FDA for market use on 15 October, 2008.

Active Ingredient:

Astepro uses Azelastine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Azelastine Hydrochloride ingredient

Treatment:

Astepro is used for treating allergic rhinitis.

Dosage:

Astepro 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 Discontinued NASAL
0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED Discontinued NASAL


Astepro is a drug owned by Meda Pharmaceuticals Inc. It is protected by 2 US drug patents filed in 2013 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'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, 4 months from now)

Active
US8071073 Compositions comprising azelastine and methods of use thereof
Jun, 2028

(3 years 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 Astepro and ongoing litigations to help you estimate the early arrival of Astepro generic.

Astepro's Litigations

Astepro 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 or infringement of this patent, with Meda Pharmaceuticals Inc. as the respondent. Click below to track the latest information on how companies are challenging Astepro's patents.


Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8071073 May, 2014 Terminated-Denied Meda Pharmaceuticals Inc. Impax Laboratories, Inc.


FDA has granted some exclusivities to Astepro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Astepro, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Astepro.

Exclusivity Information

Astepro holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Astepro's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Aug 31, 2012

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Astepro 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's family patents as well as insights into ongoing legal events on those patents.

Astepro's family patents

Astepro 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 Astepro.

Family Patents

Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

Thank you for your response 🥳



Generic Launch

Generic Release Date:

Astepro's generic launch date based on the last expiry date of its patents and exclusivities combined 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 Generics:

Azelastine Hydrochloride is the generic name for the brand Astepro. 17 different companies have already filed for the generic of Astepro, with Amneal having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Astepro's generic

How can I launch a generic of Astepro before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Astepro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Astepro'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 -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
205.5 mcg/spray 15 Dec, 2011




About Astepro

Astepro is a drug owned by Meda Pharmaceuticals Inc. It is used for treating allergic rhinitis. Astepro uses Azelastine Hydrochloride as an active ingredient. Astepro was launched by Meda Pharms in 2009.

Market Authorisation Date:

Astepro was approved by FDA for market use on 31 August, 2009.

Active Ingredient:

Astepro uses Azelastine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Azelastine Hydrochloride ingredient

Treatment:

Astepro is used for treating allergic rhinitis.

Dosage:

Astepro is available in spray, metered form for nasal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 0.1876MG BASE/SPRAY SPRAY, METERED Prescription NASAL