Asmanex Hfa Patent Expiration

Asmanex Hfa is a drug owned by Organon Llc. It is protected by 7 US drug patents filed in 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 12, 2023. Details of Asmanex 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).
US6068832 Chlorofluorocarbon-free mometasone furoate aerosol formulations
Aug, 2017

(7 years ago)

Expired
US6057307

(Pediatric)

Use of mometasone furoate for treating airway passage and lung diseases
Jul, 2014

(10 years ago)

Expired
US6365581

(Pediatric)

Use of mometasone furoate for treating airway passage and lung diseases
Jul, 2014

(10 years ago)

Expired
US5889015

(Pediatric)

Use of mometasone furoate for treating lower airway passage and lung diseases
Jul, 2014

(10 years ago)

Expired
US6365581 Use of mometasone furoate for treating airway passage and lung diseases
Jan, 2014

(10 years ago)

Expired
US5889015 Use of mometasone furoate for treating lower airway passage and lung diseases
Jan, 2014

(10 years ago)

Expired
US6057307 Use of mometasone furoate for treating airway passage and lung diseases
Jan, 2014

(10 years ago)

Expired


FDA has granted several exclusivities to Asmanex Hfa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Asmanex 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 Asmanex Hfa.

Exclusivity Information

Asmanex Hfa holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Asmanex Hfa's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Strength(NS) Aug 12, 2022
Pediatric Exclusivity(PED) Feb 12, 2023

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

Asmanex Hfa's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Asmanex Hfa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 12, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Asmanex Hfa Generic API suppliers:

Mometasone Furoate is the generic name for the brand Asmanex Hfa. 14 different companies have already filed for the generic of Asmanex Hfa, with Cosette having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Asmanex Hfa's generic

Alternative Brands for Asmanex Hfa

Asmanex Hfa which is used for the treatment of asthma., has several other brand drugs in the same treatment category and using the same active ingredient (Mometasone Furoate). 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 Treatment Area
Organon Llc
Asmanex Twisthaler

(uses Mometasone Furoate)

Used for managing and controlling symptoms of asthma.
Teva Pharm
Airduo Digihaler Used for treating asthma.
Airduo Respiclick Used for managing and treating asthma.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Mometasone Furoate. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Glenmark Speclt
Ryaltris
Intersect Ent Inc
Sinuva
Organon Llc
Dulera
Nasonex


Apart from brand drugs containing the same ingredient, some generics have also been filed for Mometasone Furoate, Asmanex Hfa's active ingredient. Check the complete list of approved generic manufacturers for Asmanex Hfa





About Asmanex Hfa

Asmanex Hfa is a drug owned by Organon Llc. It is used for the treatment of asthma. Asmanex Hfa uses Mometasone Furoate as an active ingredient. Asmanex Hfa was launched by Organon Llc in 2019.

Approval Date:

Asmanex Hfa was approved by FDA for market use on 12 August, 2019.

Active Ingredient:

Asmanex Hfa uses Mometasone Furoate as the active ingredient. Check out other Drugs and Companies using Mometasone Furoate ingredient

Treatment:

Asmanex Hfa is used for the treatment of asthma.

Dosage:

Asmanex Hfa is available in aerosol, metered form for inhalation use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.10MG/INH AEROSOL, METERED Prescription INHALATION
0.20MG/INH AEROSOL, METERED Prescription INHALATION