Breztri Aerosphere Patent Expiration

Breztri Aerosphere is a drug owned by Astrazeneca Ab. It is protected by 9 US drug patents filed from 2020 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 05, 2038. Details of Breztri Aerosphere'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).
US11833292 Drug delivery systems and related methods
Oct, 2038

(13 years from now)

Active
US11331442 Drug delivery systems and related methods
Oct, 2038

(13 years from now)

Active
US8815258 Compositions, methods and systems for respiratory delivery of two or more active agents
Mar, 2031

(6 years from now)

Active
US8703806 Compositions, methods and propellant-based systems for respiratory delivery of glycopyrrolate and one or more active agents
May, 2030

(5 years from now)

Active
US8808713 Compositions for pulmonary delivery of long-acting β2 adrenergic receptor agonists and associated methods and systems
May, 2030

(5 years from now)

Active
US8324266 Compositions, methods and systems for respiratory delivery of two or more active agents
May, 2030

(5 years from now)

Active
US9415009 Compositions, methods and systems for respiratory delivery of two or more active agents
May, 2030

(5 years from now)

Active
US10716753 Compositions for pulmonary delivery of long-acting muscarinic antagonists or long-acting B2 adrenergic receptor agonists and associated methods and systems
May, 2030

(5 years from now)

Active
US9463161 Compositions for pulmonary delivery of long-acting muscarinic antagonists and associated methods and systems
May, 2030

(5 years 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 Breztri Aerosphere's patents.

Given below is the list of recent legal activities going on the following patents of Breztri Aerosphere.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 22 May, 2024 US8324266
Payment of Maintenance Fee, 8th Year, Large Entity 27 Mar, 2024 US9463161
Payment of Maintenance Fee, 8th Year, Large Entity 31 Jan, 2024 US9415009
Payment of Maintenance Fee, 4th Year, Large Entity 03 Jan, 2024 US10716753
Mail Patent eGrant Notification 05 Dec, 2023 US11833292
Email Notification 05 Dec, 2023 US11833292
Patent eGrant Notification 05 Dec, 2023 US11833292
Patent Issue Date Used in PTA Calculation 05 Dec, 2023 US11833292
Recordation of Patent eGrant 05 Dec, 2023 US11833292
Recordation of Patent Grant Mailed 05 Dec, 2023 US11833292


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

Exclusivity Information

Breztri Aerosphere holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Breztri Aerosphere's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Combination(NC) Jul 23, 2023

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

Breztri Aerosphere's Family Patents

Breztri Aerosphere has patent protection in a total of 33 countries. It's US patent count contributes only to 16.2% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Breztri Aerosphere.

Family Patents

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Generic Launch

Generic Release Date:

Breztri Aerosphere's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 05, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Breztri Aerosphere Generics:

There are no approved generic versions for Breztri Aerosphere as of now.

Alternative Brands for Breztri Aerosphere

Breztri Aerosphere which is used for managing chronic obstructive pulmonary disease (COPD)., has several other brand drugs in the same treatment category . 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
Astrazeneca
Bevespi Aerosphere Used for the maintenance treatment of chronic obstructive pulmonary disease (COPD).





About Breztri Aerosphere

Breztri Aerosphere is a drug owned by Astrazeneca Ab. It is used for managing chronic obstructive pulmonary disease (COPD). Breztri Aerosphere uses Budesonide; Formoterol Fumarate; Glycopyrrolate as an active ingredient. Breztri Aerosphere was launched by Astrazeneca Ab in 2020.

Approval Date:

Breztri Aerosphere was approved by FDA for market use on 23 July, 2020.

Active Ingredient:

Breztri Aerosphere uses Budesonide; Formoterol Fumarate; Glycopyrrolate as the active ingredient. Check out other Drugs and Companies using Budesonide; Formoterol Fumarate; Glycopyrrolate ingredient

Treatment:

Breztri Aerosphere is used for managing chronic obstructive pulmonary disease (COPD).

Dosage:

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

Strength Dosage Form Availability Application Pathway
0.16MG/INH;0.0048MG/INH;0.009MG/INH AEROSOL, METERED Prescription INHALATION