Symbicort Patent Expiration

Symbicort is a drug owned by Astrazeneca Lp. It is protected by 33 US drug patents filed from 2013 to 2022. Out of these, 10 drug patents are active and 23 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 07, 2029. Details of Symbicort'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).
US8616196

(Pediatric)

Inhalation device and a method for assembling said inhalation device
Oct, 2029

(4 years from now)

Active
US8528545

(Pediatric)

Inhaler device that reduces the risk for miscounting a dosage
Apr, 2029

(4 years from now)

Active
US8616196 Inhalation device and a method for assembling said inhalation device
Apr, 2029

(4 years from now)

Active
US8528545 Inhaler device that reduces the risk for miscounting a dosage
Oct, 2028

(4 years from now)

Active
US8387615

(Pediatric)

Inhaler cap strap
Sep, 2027

(2 years from now)

Active
US8387615 Inhaler cap strap
Mar, 2027

(2 years from now)

Active
US7587988

(Pediatric)

Inhaler device counter
Oct, 2026

(1 year, 11 months from now)

Active
US7587988 Inhaler device counter
Apr, 2026

(1 year, 5 months from now)

Active
US8875699

(Pediatric)

Inhaler cap strap
May, 2025

(6 months from now)

Active
US8875699 Inhaler cap strap
Nov, 2024

(26 days from now)

Active
US10166247

(Pediatric)

Composition for inhalation
Jul, 2023

(1 year, 2 months ago)

Expired
US11311558

(Pediatric)

Composition for inhalation
Jul, 2023

(1 year, 2 months ago)

Expired
US7759328

(Pediatric)

Composition for inhalation
Jul, 2023

(1 year, 2 months ago)

Expired
US8143239

(Pediatric)

Composition for inhalation
Jul, 2023

(1 year, 2 months ago)

Expired
US8575137

(Pediatric)

Composition for inhalation
Jul, 2023

(1 year, 2 months ago)

Expired
US11311558 Composition for inhalation
Jan, 2023

(1 year, 8 months ago)

Expired
US8575137 Composition for inhalation
Jan, 2023

(1 year, 8 months ago)

Expired
US10166247 Composition for inhalation
Jan, 2023

(1 year, 8 months ago)

Expired
US8143239 Composition for inhalation
Jan, 2023

(1 year, 8 months ago)

Expired
US7759328 Composition for inhalation
Jan, 2023

(1 year, 8 months ago)

Expired
US7967011

(Pediatric)

Inhalation device
Feb, 2022

(2 years ago)

Expired
US7967011 Inhalation device
Aug, 2021

(3 years ago)

Expired
US7367333

(Pediatric)

Inhalation device
May, 2019

(5 years ago)

Expired
US8461211

(Pediatric)

Use for budesonide and formoterol
Mar, 2019

(5 years ago)

Expired
US7897646

(Pediatric)

Use for budesonide and formoterol
Mar, 2019

(5 years ago)

Expired
US7367333 Inhalation device
Nov, 2018

(5 years ago)

Expired
US8461211 Use for budesonide and formoterol
Sep, 2018

(6 years ago)

Expired
US7897646 Use for budesonide and formoterol
Sep, 2018

(6 years ago)

Expired
US6123924

(Pediatric)

Pressurized aerosol inhalation compositions
Mar, 2018

(6 years ago)

Expired
US6123924 Pressurized aerosol inhalation compositions
Sep, 2017

(7 years ago)

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

(10 years ago)

Expired
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, 2012

(11 years ago)

Expired
US6641800 Pressurized aerosol compositions comprising powdered medicament dispersed in hydrofluoroalkane
Sep, 2012

(12 years ago)

Expired


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 Symbicort's patents.

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

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


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 Symbicort and ongoing litigations to help you estimate the early arrival of Symbicort generic.

Symbicort's Litigations

Symbicort been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 09, 2017, against patent number US7759328. The petitioner Complex Innovations, LLC, challenged the validity of this patent, with AstraZeneca AB as the respondent. Click below to track the latest information on how companies are challenging Symbicort's patents.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7759328 January, 2017 Terminated-Denied
(24 Jul, 2017)
AstraZeneca AB Complex Innovations, LLC


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

Exclusivity Information

Symbicort holds 5 exclusivities. All of its exclusivities have expired in 2020. Details of Symbicort's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-582) Feb 27, 2012
New Patient Population(NPP) Jan 27, 2020
Pediatric Exclusivity(PED) Jul 27, 2020
M(M-210) Sep 11, 2020
M(M-214) Dec 20, 2020

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

Several oppositions have been filed on Symbicort's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Symbicort's generic, the next section provides detailed information on ongoing and past EP oppositions related to Symbicort patents.

Symbicort's Oppositions Filed in EPO

Symbicort has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 25, 2009, by Norton Healthcare Limited. This opposition was filed on patent number EP03703575A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP03703575A Nov, 2009 NORTON HEALTHCARE LIMITED Revoked


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

Symbicort's Family Patents

Symbicort has patent protection in a total of 41 countries. It's US patent count contributes only to 8.7% of its total global patent coverage. 10 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Symbicort.

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Symbicort's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 07, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Symbicort Generics:

Budesonide; Formoterol Fumarate Dihydrate is the generic name for the brand Symbicort. 1 company has already filed for the generic of Symbicort. Check out the entire list of companies who have already received approval for Symbicort's generic

How can I launch a generic of Symbicort before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Symbicort's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Symbicort'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 Symbicort -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
80 mcg/4.5 mcg per inhalation and 160 mcg/4.5 mcg per inhalation 26 Jun, 2018 1 15 Mar, 2022 16 Oct, 2028 Deferred





About Symbicort

Symbicort is a drug owned by Astrazeneca Lp. It is used for managing and treating chronic respiratory conditions like COPD and asthma. Symbicort uses Budesonide; Formoterol Fumarate Dihydrate as an active ingredient. Symbicort was launched by Astrazeneca in 2006.

Approval Date:

Symbicort was approved by FDA for market use on 21 July, 2006.

Active Ingredient:

Symbicort uses Budesonide; Formoterol Fumarate Dihydrate as the active ingredient. Check out other Drugs and Companies using Budesonide; Formoterol Fumarate Dihydrate ingredient

Treatment:

Symbicort is used for managing and treating chronic respiratory conditions like COPD and asthma.

Dosage:

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

Strength Dosage Form Availability Application Pathway
0.08MG/INH;0.0045MG/INH AEROSOL, METERED Prescription INHALATION
0.16MG/INH;0.0045MG/INH AEROSOL, METERED Prescription INHALATION