Budesonide Patent Expiration

Budesonide is Used for long-term management of asthma in adults and children aged 6 and older, including those needing oral corticosteroids. It was first introduced by Astrazeneca Lp in its drug Rhinocort on Feb 14, 1994. Other drugs containing Budesonide are Eohilia, Ortikos, Pulmicort Flexhaler, Tarpeyo, Pulmicort, Entocort Ec, Rhinocort Allergy, Pulmicort Respules, Uceris. 30 different companies have introduced drugs containing Budesonide.


Budesonide Patents

Given below is the list of patents protecting Budesonide, 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
Tarpeyo US11896719 Pharmaceutical compositions Jan 23, 2043 Calliditas
Tarpeyo US12171882 Pharmaceutical compositions Jan 23, 2043 Calliditas
Tarpeyo US12171883 Pharmaceutical compositions Jan 23, 2043 Calliditas
Tarpeyo US12311057 Pharmaceutical compositions Jan 23, 2043 Calliditas
Eohilia US11260064 Stable corticosteroid compositions Jan 10, 2039 Takeda Pharms Usa
Eohilia US11564934 Stable corticosteroid compositions Jan 10, 2039 Takeda Pharms Usa
Ortikos US10172802 Oral pharmaceutical dosage forms of budesonide Sep 09, 2036 Sun Pharm Inds Inc
Ortikos US9707182 Oral pharmaceutical dosage forms of budesonide Sep 09, 2036 Sun Pharm Inds Inc
Uceris US10307375 Controlled release and taste masking oral pharmaceutical composition Sep 07, 2031 Salix
Uceris US10660858 Controlled release and taste masking oral pharmaceutical composition Sep 07, 2031 Salix
Uceris US8895064 Controlled release and taste masking oral pharmaceutical composition Sep 07, 2031 Salix
Uceris US9132093 Controlled release and taste making oral pharmaceutical composition Sep 07, 2031 Salix
Uceris US9192581 Controlled release and taste masking oral pharmaceutical composition Sep 07, 2031 Salix
Eohilia US8324192 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Aug 03, 2029 Takeda Pharms Usa
Eohilia US9050368 Corticosteroid compositions Aug 01, 2029 Takeda Pharms Usa
Tarpeyo US8491932 Compositions for the oral delivery of corticosteroids May 07, 2029 Calliditas
Eohilia US10293052 Compositions for the treatment of gastrointestinal inflammation Nov 22, 2028 Takeda Pharms Usa
Eohilia US11357859 Compositions for the treatment of gastrointestinal inflammation Nov 12, 2028 Takeda Pharms Usa
Eohilia US11197822 Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract Nov 09, 2026 Takeda Pharms Usa
Eohilia US11413296 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Nov 09, 2026 Takeda Pharms Usa
Eohilia US8497258 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Nov 09, 2026 Takeda Pharms Usa
Eohilia US8679545 Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract Nov 09, 2026 Takeda Pharms Usa
Eohilia US8975243 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Nov 09, 2026 Takeda Pharms Usa
Eohilia US9119863 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Nov 09, 2026 Takeda Pharms Usa
Uceris US10064878 Controlled release and taste masking oral pharmaceutical compositions Jun 09, 2020

(Expired)

Salix
Uceris US10105374 Controlled release and taste masking oral pharmaceutical compositions Jun 09, 2020

(Expired)

Salix
Uceris US10143698 Controlled release and taste masking oral pharmaceutical compositions Jun 09, 2020

(Expired)

Salix
Uceris US7410651 Controlled release and taste masking oral pharmaceutical composition Jun 09, 2020

(Expired)

Salix
Uceris US7431943 Controlled release and taste masking oral pharmaceutical compositions Jun 09, 2020

(Expired)

Salix
Uceris US8293273 Controlled release and taste masking oral pharmaceutical composition Jun 09, 2020

(Expired)

Salix
Uceris US8784888 Controlled release and taste masking oral pharmaceutical composition Jun 09, 2020

(Expired)

Salix
Uceris US9320716 Controlled release and taste masking oral pharmaceutical compositions Jun 09, 2020

(Expired)

Salix
Uceris US9532954 Controlled release and taste masking oral pharmaceutical compositions Jun 09, 2020

(Expired)

Salix
Uceris USRE43799 Controlled release and taste masking oral pharmaceutical composition Jun 09, 2020

(Expired)

Salix
Pulmicort Respules US6598603

(Pediatric)

Method for treating respiratory diseases Jun 23, 2019

(Expired)

Astrazeneca
Pulmicort Respules US6899099

(Pediatric)

Method for treating a respiratory disease Jun 23, 2019

(Expired)

Astrazeneca
Pulmicort Respules US7524834

(Pediatric)

Sterile powders, formulations, and methods for producing the same May 11, 2019

(Expired)

Astrazeneca
Pulmicort Respules US6598603 Method for treating respiratory diseases Dec 23, 2018

(Expired)

Astrazeneca
Pulmicort Respules US6899099 Method for treating a respiratory disease Dec 23, 2018

(Expired)

Astrazeneca
Pulmicort Respules US7524834 Sterile powders, formulations, and methods for producing the same Nov 11, 2018

(Expired)

Astrazeneca
Pulmicort Flexhaler US6142145 Inhalation device May 08, 2018

(Expired)

Cheplapharm
Pulmicort Flexhaler US7143764 Inhalation device Mar 13, 2018

(Expired)

Cheplapharm
Pulmicort Flexhaler US6027714 Formulation for inhalation Jan 09, 2018

(Expired)

Cheplapharm
Pulmicort Flexhaler US6287540 Formulation for inhalation Jan 09, 2018

(Expired)

Cheplapharm
Rhinocort US6291445

(Pediatric)

Low dose budesonide formulations and uses thereof Oct 29, 2017

(Expired)

Astrazeneca
Rhinocort US6686346

(Pediatric)

Formulation Oct 29, 2017

(Expired)

Astrazeneca
Rhinocort US6986904

(Pediatric)

Formulation Oct 29, 2017

(Expired)

Astrazeneca
Rhinocort US6291445 Low dose budesonide formulations and uses thereof Apr 29, 2017

(Expired)

Astrazeneca
Rhinocort US6686346 Formulation Apr 29, 2017

(Expired)

Astrazeneca
Rhinocort US6986904 Formulation Apr 29, 2017

(Expired)

Astrazeneca
Uceris US5914122 Stable budesonide solutions, method of preparing them and use of these solutions as enema preparations and pharmaceutical foams Dec 19, 2015

(Expired)

Salix
Entocort Ec US5643602

(Pediatric)

Oral composition for the treatment of inflammatory bowel disease Jan 01, 2015

(Expired)

Padagis Us
Entocort Ec US5643602 Oral composition for the treatment of inflammatory bowel disease Jul 01, 2014

(Expired)

Padagis Us



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's patents.

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

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 10 Jun, 2024 US8293273(Litigated)
Expire Patent 03 Jun, 2024 US9320716
Email Notification 27 Mar, 2024 US11896719
Patent eCofC Notification 26 Mar, 2024 US11896719
Mail Patent eCofC Notification 26 Mar, 2024 US11896719
Email Notification 26 Mar, 2024 US11896719
Recordation of Patent eCertificate of Correction 26 Mar, 2024 US11896719
Post Issue Communication - Certificate of Correction 05 Mar, 2024 US11896719
Recordation of Patent eGrant 13 Feb, 2024 US11896719
Email Notification 13 Feb, 2024 US11896719


Budesonide's Family Patents

Family Patents

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Budesonide Generic API Manufacturers

Several generic applications have been filed for Budesonide. The first generic version for Budesonide was by Teva Pharmaceuticals Usa and was approved on Nov 18, 2008. And the latest generic version is by Eugia Pharma Specialities Ltd and was approved on Nov 29, 2023.

Given below is the list of companies who have filed for Budesonide generic, along with the locations of their manufacturing plants worldwide.


Budesonide News

In a surprising turn of events, Takeda successfully obtains FDA endorsement for previously overlooked Eohilia drug following noteworthy findings

12 Feb, 2024

See More