Pulmicort Respules is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 6 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 23, 2019. Details of Pulmicort Respules'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). | |||
|
US6598603 (Pediatric) | Method for treating respiratory diseases |
Jun, 2019
(7 years ago) |
Expired
|
|
US6899099 (Pediatric) | Method for treating a respiratory disease |
Jun, 2019
(7 years ago) |
Expired
|
|
US7524834 (Pediatric) | Sterile powders, formulations, and methods for producing the same |
May, 2019
(7 years ago) |
Expired
|
| US6598603 | Method for treating respiratory diseases |
Dec, 2018
(7 years ago) |
Expired
|
| US6899099 | Method for treating a respiratory disease |
Dec, 2018
(7 years ago) |
Expired
|
| US7524834 | Sterile powders, formulations, and methods for producing the same |
Nov, 2018
(7 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 Pulmicort Respules's patents.
Latest Legal Activities on Pulmicort Respules's Patents
Given below is the list of recent legal activities going on the following patents of Pulmicort Respules.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 31 May, 2021 | US7524834 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 14 Dec, 2020 | US7524834 (Litigated) |
| Change in Power of Attorney (May Include Associate POA)
Critical | 11 Jul, 2014 | US6899099 |
| Email Notification
Critical | 11 Jul, 2014 | US6899099 |
| Correspondence Address Change
Critical | 10 Jul, 2014 | US6899099 |
| Email Notification
Critical | 08 Jul, 2014 | US7524834 (Litigated) |
| Change in Power of Attorney (May Include Associate POA)
Critical | 08 Jul, 2014 | US7524834 (Litigated) |
| Correspondence Address Change
Critical | 07 Jul, 2014 | US7524834 (Litigated) |
| Grant Request for Retroactive License | 21 Feb, 2012 | US7524834 (Litigated) |
| Mail-Petition Decision - Granted | 12 Dec, 2011 | US7524834 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but
Pulmicort Respules 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 Pulmicort Respules's family patents as well as insights into
ongoing legal events
on those patents.
Pulmicort Respules's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Pulmicort Respules:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Pulmicort Respules's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 23, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pulmicort Respules Generic API suppliers:
Budesonide is the generic name for the brand Pulmicort Respules. 22 different companies have already filed for the generic of Pulmicort Respules, with Sandoz having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Pulmicort Respules's generic
How can I launch a generic of Pulmicort Respules before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pulmicort Respules's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pulmicort Respules'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 Pulmicort Respules -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 28 May, 2010 | 23 Dec, 2018 | Eligible | 27 Sep, 2013 | Less | |
| 15 Sep, 2005 | 27 Feb, 2006 | Extinguished | 18 Nov, 2008 | Less |
Alternative Brands for Pulmicort Respules
Pulmicort Respules which is used for the maintenance and prophylactic therapy of asthma through once-daily nebulized budesonide., has several other brand drugs using the same active ingredient (Budesonide). 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 | ||||
|---|---|---|---|---|---|
| Astrazeneca |
| ||||
| Astrazeneca Ab |
| ||||
| Calliditas |
| ||||
| Cheplapharm |
| ||||
| Padagis Us |
| ||||
| Salix |
| ||||
| Sun Pharm Inds Inc |
| ||||
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Budesonide, Pulmicort Respules's active ingredient. Check the complete list of approved generic manufacturers for Pulmicort Respules
About Pulmicort Respules
Pulmicort Respules is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for the maintenance and prophylactic therapy of asthma through once-daily nebulized budesonide. Pulmicort Respules uses Budesonide as an active ingredient. Pulmicort Respules was launched by Astrazeneca in 2000.
Approval Date:
Pulmicort Respules was approved by FDA for market use on 08 August, 2000.
Active Ingredient:
Pulmicort Respules uses Budesonide as the active ingredient. Check out other Drugs and Companies using Budesonide ingredient
Treatment:
Pulmicort Respules is used for the maintenance and prophylactic therapy of asthma through once-daily nebulized budesonide.
Dosage:
Pulmicort Respules is available in suspension form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.25MG/2ML | SUSPENSION | Prescription | INHALATION |
| 1MG/2ML | SUSPENSION | Prescription | INHALATION |
| 0.5MG/2ML | SUSPENSION | Prescription | INHALATION |