Aerospan Hfa is a drug owned by Mylan Specialty Lp. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 06, 2018. Details of Aerospan Hfa'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). | |||
| US5980867 | Flunisolide aerosol formulations |
Jul, 2018
(6 years ago) |
Expired
|
| US5776433 | Flunisolide aerosol formulations |
Jul, 2015
(9 years ago) |
Expired
|
FDA has granted several exclusivities to Aerospan Hfa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aerospan Hfa, 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 Aerospan Hfa.
Exclusivity Information
Aerospan Hfa holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Aerospan Hfa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-128) | Aug 28, 2016 |
US patents provide insights into the exclusivity only within the United States, but Aerospan Hfa 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 Aerospan Hfa's family patents as well as insights into ongoing legal events on those patents.
Aerospan Hfa's Family Patents
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Generic Launch
Generic Release Date:
Aerospan Hfa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 06, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aerospan Hfa Generic API suppliers:
Flunisolide is the generic name for the brand Aerospan Hfa. 4 different companies have already filed for the generic of Aerospan Hfa, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aerospan Hfa's generic
About Aerospan Hfa
Aerospan Hfa is a drug owned by Mylan Specialty Lp. Aerospan Hfa uses Flunisolide as an active ingredient. Aerospan Hfa was launched by Mylan Speciality Lp in 2006.
Approval Date:
Aerospan Hfa was approved by FDA for market use on 27 January, 2006.
Active Ingredient:
Aerospan Hfa uses Flunisolide as the active ingredient. Check out other Drugs and Companies using Flunisolide ingredient
Dosage:
Aerospan Hfa is available in aerosol, metered form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.078MG/INH | AEROSOL, METERED | Discontinued | INHALATION |