Pulmicort Respules Patent Expiration

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

(5 years ago)

Expired
US6899099

(Pediatric)

Method for treating a respiratory disease
Jun, 2019

(5 years ago)

Expired
US7524834

(Pediatric)

Sterile powders, formulations, and methods for producing the same
May, 2019

(5 years ago)

Expired
US6899099 Method for treating a respiratory disease
Dec, 2018

(5 years ago)

Expired
US6598603 Method for treating respiratory diseases
Dec, 2018

(5 years ago)

Expired
US7524834 Sterile powders, formulations, and methods for producing the same
Nov, 2018

(6 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.

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

Activity Date Patent Number
Patent litigations
Expire Patent 31 May, 2021 US7524834 (Litigated)
Maintenance Fee Reminder Mailed 14 Dec, 2020 US7524834 (Litigated)
Change in Power of Attorney (May Include Associate POA) 11 Jul, 2014 US6899099
Email Notification 11 Jul, 2014 US6899099
Correspondence Address Change 10 Jul, 2014 US6899099
Email Notification 08 Jul, 2014 US7524834 (Litigated)
Change in Power of Attorney (May Include Associate POA) 08 Jul, 2014 US7524834 (Litigated)
Correspondence Address Change 07 Jul, 2014 US7524834 (Litigated)
Grant Request for Retroactive License 21 Feb, 2012 US7524834 (Litigated)
Mail-Petition Decision - Granted 12 Dec, 2011 US7524834 (Litigated)

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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


Family Patents

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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. 21 different companies have already filed for the generic of Pulmicort Respules, with Sun Pharm 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 ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.25 mg/2 mL and 0.5 mg/2 mL 15 Sep, 2005 1 18 Nov, 2008 27 Feb, 2006 Extinguished
1 mg/2 mL 28 May, 2010 1 27 Sep, 2013 23 Dec, 2018 Eligible

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
Airsupra
Rhinocort
Symbicort
Symbicort Aerosphere
Astrazeneca Ab
Breztri Aerosphere
Calliditas
Tarpeyo
Cheplapharm
Pulmicort Flexhaler
Padagis Us
Entocort Ec
Salix
Uceris
Sun Pharm Inds Inc
Ortikos
Takeda Pharms Usa
Eohilia


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