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 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 |
| US9919050 | Compositions comprising azelastine |
Nov, 2025
(a year from now) | Active |
| US8518919 | Compositions comprising azelastine and methods of use thereof |
Nov, 2025
(a year 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's patents.
Latest Legal Activities on Astepro's Patents
Given below is the list of recent legal activities going on the following patents of Astepro.
| 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 and ongoing litigations to help you estimate the early arrival of Astepro generic.
Astepro's Litigations
Astepro 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's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8071073 | May, 2014 |
Terminated-Denied
(29 Jul, 2014) | 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) | Aug 31, 2012 |
| M(M-129) | Aug 30, 2016 |
| New Patient Population(NPP) | Feb 20, 2018 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
Alternative Brands for Astepro
Astepro which is used for treating allergic rhinitis., has several other brand drugs 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 | ||
|---|---|---|---|
| Bayer Hlthcare |
| ||
| Mylan Speciality Lp |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Azelastine Hydrochloride, Astepro's active ingredient. Check the complete list of approved generic manufacturers for Astepro
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.
Approval 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 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
(a year 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's patents.
Latest Legal Activities on Astepro's Patents
Given below is the list of recent legal activities going on the following patents of Astepro.
| 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 and ongoing litigations to help you estimate the early arrival of Astepro generic.
Astepro's Litigations
Astepro 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's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
| | ||||
| US8071073 | May, 2014 |
Terminated-Denied
(29 Jul, 2014) | 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) | Aug 31, 2012 |
| M(M-129) | Aug 30, 2016 |
| New Patient Population(NPP) | Feb 20, 2018 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
Alternative Brands for Astepro
Astepro which is used for treating allergic rhinitis., has several other brand drugs 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 | ||
|---|---|---|---|
| Bayer Hlthcare |
| ||
| Mylan Speciality Lp |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Azelastine Hydrochloride, Astepro's active ingredient. Check the complete list of approved generic manufacturers for Astepro
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.
Approval 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 |