Budesonide; Formoterol Fumarate Dihydrate Patent Expiration

Budesonide; Formoterol Fumarate Dihydrate is Used for managing and treating chronic respiratory conditions like COPD and asthma. It was first introduced by Astrazeneca Lp in its drug Symbicort on Jul 21, 2006. 2 different companies have introduced drugs containing Budesonide; Formoterol Fumarate Dihydrate.


Budesonide; Formoterol Fumarate Dihydrate Patents

Given below is the list of patents protecting Budesonide; Formoterol Fumarate Dihydrate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Symbicort US8616196

(Pediatric)

Inhalation device and a method for assembling said inhalation device Oct 07, 2029 Astrazeneca
Symbicort US8528545

(Pediatric)

Inhaler device that reduces the risk for miscounting a dosage Apr 16, 2029 Astrazeneca
Symbicort US8616196 Inhalation device and a method for assembling said inhalation device Apr 07, 2029 Astrazeneca
Symbicort US8528545 Inhaler device that reduces the risk for miscounting a dosage Oct 16, 2028 Astrazeneca
Symbicort US8387615

(Pediatric)

Inhaler cap strap Sep 26, 2027 Astrazeneca
Symbicort US8387615 Inhaler cap strap Mar 26, 2027 Astrazeneca
Symbicort US7587988

(Pediatric)

Inhaler device counter Oct 10, 2026 Astrazeneca
Symbicort US7587988 Inhaler device counter Apr 10, 2026 Astrazeneca
Symbicort US8875699

(Pediatric)

Inhaler cap strap May 10, 2025 Astrazeneca
Symbicort US8875699 Inhaler cap strap Nov 10, 2024 Astrazeneca
Symbicort US10166247

(Pediatric)

Composition for inhalation Jul 29, 2023

(Expired)

Astrazeneca
Symbicort US11311558

(Pediatric)

Composition for inhalation Jul 29, 2023

(Expired)

Astrazeneca
Symbicort US7759328

(Pediatric)

Composition for inhalation Jul 29, 2023

(Expired)

Astrazeneca
Symbicort US8143239

(Pediatric)

Composition for inhalation Jul 29, 2023

(Expired)

Astrazeneca
Symbicort US8575137

(Pediatric)

Composition for inhalation Jul 29, 2023

(Expired)

Astrazeneca
Symbicort US10166247 Composition for inhalation Jan 29, 2023

(Expired)

Astrazeneca
Symbicort US11311558 Composition for inhalation Jan 29, 2023

(Expired)

Astrazeneca
Symbicort US7759328 Composition for inhalation Jan 29, 2023

(Expired)

Astrazeneca
Symbicort US8143239 Composition for inhalation Jan 29, 2023

(Expired)

Astrazeneca
Symbicort US8575137 Composition for inhalation Jan 29, 2023

(Expired)

Astrazeneca
Symbicort US7967011

(Pediatric)

Inhalation device Feb 11, 2022

(Expired)

Astrazeneca
Symbicort US7967011 Inhalation device Aug 11, 2021

(Expired)

Astrazeneca
Symbicort US7367333

(Pediatric)

Inhalation device May 11, 2019

(Expired)

Astrazeneca
Symbicort US7897646

(Pediatric)

Use for budesonide and formoterol Mar 09, 2019

(Expired)

Astrazeneca
Symbicort US8461211

(Pediatric)

Use for budesonide and formoterol Mar 09, 2019

(Expired)

Astrazeneca
Symbicort US7367333 Inhalation device Nov 11, 2018

(Expired)

Astrazeneca
Symbicort US7897646 Use for budesonide and formoterol Sep 09, 2018

(Expired)

Astrazeneca
Symbicort US8461211 Use for budesonide and formoterol Sep 09, 2018

(Expired)

Astrazeneca
Symbicort US6123924

(Pediatric)

Pressurized aerosol inhalation compositions Mar 26, 2018

(Expired)

Astrazeneca
Symbicort US6123924 Pressurized aerosol inhalation compositions Sep 26, 2017

(Expired)

Astrazeneca
Symbicort US5674860 Combination of a bronchodilator and a steroidal anti-inflammatory drug for the treatment of respiratory disorders Oct 07, 2014

(Expired)

Astrazeneca
Symbicort US5972919 Combination of a bronchodilator and a steroidal anti-inflammatory drug for the treatment of respiratory disorders, as well as its use and the preparation thereof Dec 17, 2012

(Expired)

Astrazeneca
Symbicort US6641800 Pressurized aerosol compositions comprising powdered medicament dispersed in hydrofluoroalkane Sep 23, 2012

(Expired)

Astrazeneca



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 Budesonide; Formoterol Fumarate Dihydrate's patents.

Given below is the list recent legal activities going on the following patents of Budesonide; Formoterol Fumarate Dihydrate.

Activity Date Patent Number
Patent litigations
Expire Patent 29 Apr, 2024 US8143239(Litigated)
Maintenance Fee Reminder Mailed 13 Nov, 2023 US8143239(Litigated)
Expire Patent 31 Jul, 2023 US7967011
Expire Patent 03 Apr, 2023 US7897646
Maintenance Fee Reminder Mailed 13 Feb, 2023 US7967011
Maintenance Fee Reminder Mailed 17 Oct, 2022 US7897646
Payment of Maintenance Fee, 4th Year, Large Entity 15 Jun, 2022 US10166247(Litigated)
Recordation of Patent Grant Mailed 26 Apr, 2022 US11311558(Litigated)
Patent Issue Date Used in PTA Calculation 26 Apr, 2022 US11311558(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 20 Apr, 2022 US8875699


Budesonide; Formoterol Fumarate Dihydrate's Family Patents

Family Patents

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Budesonide; Formoterol Fumarate Dihydrate Generics

Several generic applications have been filed for Budesonide; Formoterol Fumarate Dihydrate.

Given below is the list of companies who have filed for Budesonide; Formoterol Fumarate Dihydrate generic.


1. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Budesonide; Formoterol Fumarate Dihydrate. All of these versions come by the name BREYNA. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.08MG/INH; 0.0045MG/INH aerosol, metered Prescription INHALATION AB Mar 15, 2022
0.16MG/INH; 0.0045MG/INH aerosol, metered Prescription INHALATION AB Mar 15, 2022