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.
Latest 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 |
---|---|---|
Expire Patent Critical | 29 Apr, 2024 | US8143239 (Litigated) |
Maintenance Fee Reminder Mailed Critical | 13 Nov, 2023 | US8143239 (Litigated) |
Expire Patent Critical | 31 Jul, 2023 | US7967011 |
Expire Patent Critical | 03 Apr, 2023 | US7897646 |
Maintenance Fee Reminder Mailed Critical | 13 Feb, 2023 | US7967011 |
Maintenance Fee Reminder Mailed Critical | 17 Oct, 2022 | US7897646 |
Payment of Maintenance Fee, 4th Year, Large Entity | 15 Jun, 2022 | US10166247 (Litigated) |
Recordation of Patent Grant Mailed Critical | 26 Apr, 2022 | US11311558 (Litigated) |
Patent Issue Date Used in PTA Calculation Critical | 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.
Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
---|---|---|---|---|
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 |
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 |
---|---|---|---|
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
Explore Our Curated Drug Screens
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 |