Budesonide
As of the edition of 20 October 2026, Budesonide is a small molecule: marketed, first approved in 1990 (CH); acts on NR3C1; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Rhinocort
- First approved
- 26 March 1990 (CH)
- Approvals on record
- 63 in 8 regions
- Holder of the most recent approval
- AstraZeneca; 18 holders in all
- Withdrawn from market
- 9 January 2017 (in some regions)
- Registered trials
- 354, 42 stopped early
- Disease areas
- Lungs and airways; Immune system; Digestive system; Ear, nose and throat; Infections; Blood and lymph
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029.
Takeda holds a later exclusivity on its own new formulation or combination product, ending 2031; it does not protect the original drug.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product3 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
5 companies on route B because of this drug.
Companies on route B for this drug
In the product5 companies are on route B because of Budesonide.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| NR3C1 | Glucocorticoid receptor | P04150 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 48 | 28 | 9 | 5 |
| Phase 1 | 36 | 31 | 0 | 2 |
| Phase 2 | 57 | 33 | 9 | 12 |
| Phase 3 | 127 | 96 | 8 | 11 |
| Phase 4 | 86 | 47 | 13 | 12 |
| All trials | 354 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant, Acquired holder and Lead sponsor of trials | 1990 to now |
| Astra | Applicant | 1994 to now |
| Dr. Falk Pharma | Later holder and Lead sponsor of trials | 2001 to now |
| Calliditas Therapeutics | Later holder and Lead sponsor of trials | 2005 to now |
| Takeda | Later holder and Lead sponsor of trials | 2009 to now |
| Bausch Health | Acquired holder and Lead sponsor of trials | 2009 to now |
| Santarus | Later holder | 2013 to now |
| Teva | Applicant and Lead sponsor of trials | 2014 to now |
| Ferring Pharmaceuticals | Later holder and Lead sponsor of trials | 2015 to now |
| Zeria Pharmaceutical | Applicant | 2016 to now |
| EA Pharma | Later holder | 2017 to now |
| Aché Laboratórios Farmacêuticos | Applicant | 2019 to now |
| Padagis | Acquired holder and Lead sponsor of trials | 2021 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2021 to now |
| Stada Arzneimittel | Later holder | 2022 to now |
| Cheplapharm Arzneimittel | Acquired holder | 2024 to now |
| Kenvue Brands | Acquired holder | 2025 to now |