FDA Orange Book · active-ingredient family
Budesonide
Budesonide: 11 brands, 21 generics; first approved Feb 14, 1994; generic available.
Generic available4 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 21 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
11
Generics (ANDA)
21
Listed patents
24
Next patent expiry
Nov 09, 2026
in 3 mo
Brand (NDA) products
Originator applications
- TAKEDA PHARMS USANDA 2139762024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/10ML SUSPENSION ORAL Rx — - CALLIDITASNDA 2159352021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG CAPSULE, DELAYED RELEASE ORAL Rx — - ORTIKOSRLDSUN PHARM INDS INCNDA 21192920192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG CAPSULE, DELAYED RELEASE ORAL Discontinued — 9MG CAPSULE, DELAYED RELEASE ORAL Discontinued — - KENVUE BRANDSNDA 0207462015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.032MG/SPRAY SPRAY, METERED NASAL OTC — - UCERISRLDSALIXNDA 2056132014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ACTUATION AEROSOL, FOAM RECTAL Rx AB - SALIXNDA 2036342013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 9MG TABLET, EXTENDED RELEASE ORAL Rx AB - CHEPLAPHARMNDA 02194920062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.08MG/INH POWDER, METERED INHALATION Rx — 0.16MG/INH POWDER, METERED INHALATION Rx — - PADAGIS USNDA 0213242001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG CAPSULE, DELAYED RELEASE ORAL Rx AB - ASTRAZENECANDA 02092920003 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/2ML SUSPENSION INHALATION Rx AN 0.5MG/2ML SUSPENSION INHALATION Rx AN 1MG/2ML SUSPENSION INHALATION Rx AN - ASTRAZENECANDA 02044119972 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.16MG/INH POWDER, METERED INHALATION Discontinued — 0.32MG/INH POWDER, METERED INHALATION Discontinued — - ASTRAZENECANDA 0202331994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.032MG/INH AEROSOL, METERED NASAL Discontinued —
Generic (ANDA) products (21)
Abbreviated applications
- BUDESONIDEEUGIA PHARMAANDA 2166672023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/2ML SUSPENSION INHALATION Rx AN - BUDESONIDERSPADAGIS ISRAELANDA 2153282023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG/ACTUATION AEROSOL, FOAM RECTAL Rx AB - BUDESONIDESUN PHARMANDA 21192220213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/2ML SUSPENSION INHALATION Rx AN 0.5MG/2ML SUSPENSION INHALATION Rx AN 1MG/2ML SUSPENSION INHALATION Rx AN - BUDESONIDEMYLANANDA 2088512020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 9MG TABLET, EXTENDED RELEASE ORAL Rx AB - BUDESONIDELUPINANDA 2108972018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/2ML SUSPENSION INHALATION Rx AN - BUDESONIDEACTAVIS LABS FL INCANDA 2054572018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 9MG TABLET, EXTENDED RELEASE ORAL Rx AB - BUDESONIDECIPLAANDA 20571020173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/2ML SUSPENSION INHALATION Rx AN 0.5MG/2ML SUSPENSION INHALATION Rx AN 1MG/2ML SUSPENSION INHALATION Rx AN - BUDESONIDESCIECURE PHARMA INCANDA 2090412017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG CAPSULE, DELAYED RELEASE ORAL Discontinued — - BUDESONIDEAMNEAL PHARMSANDA 2062002017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG CAPSULE, DELAYED RELEASE ORAL Rx AB - BUDESONIDEZYDUS PHARMSANDA 2061342017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG CAPSULE, DELAYED RELEASE ORAL Rx AB - BUDESONIDERISINGANDA 2073672017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG CAPSULE, DELAYED RELEASE ORAL Rx AB - BUDESONIDENATCOANDA 2067242016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG CAPSULE, DELAYED RELEASE ORAL Discontinued — - BUDESONIDEDR REDDYS LABS SAANDA 2066232016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG CAPSULE, DELAYED RELEASE ORAL Rx AB - BUDESONIDETEVA PHARMS USAANDA 2045482016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/2ML SUSPENSION INHALATION Rx AN - BUDESONIDEAPOTEXANDA 0789492015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.032MG/SPRAY SPRAY, METERED NASAL OTC — - BUDESONIDEBARR LABS DIV TEVAANDA 0903792014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG CAPSULE, DELAYED RELEASE ORAL Discontinued — - BUDESONIDESANDOZANDA 20196620133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/2ML SUSPENSION INHALATION Discontinued — 0.5MG/2ML SUSPENSION INHALATION Discontinued — 0.25MG/2ML SUSPENSION INHALATION Discontinued — - BUDESONIDEIMPAX LABS INCANDA 07840420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/2ML SUSPENSION INHALATION Rx AN 0.5MG/2ML SUSPENSION INHALATION Rx AN - BUDESONIDEAUROBINDO PHARMA USAANDA 0904102011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG CAPSULE, DELAYED RELEASE ORAL Rx AB - BUDESONIDENEPHRONANDA 07820220092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/2ML SUSPENSION INHALATION Rx AN 0.5MG/2ML SUSPENSION INHALATION Rx AN - BUDESONIDETEVA PHARMSANDA 07751920082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.25MG/2ML SUSPENSION INHALATION Rx AN 0.5MG/2ML SUSPENSION INHALATION Rx AN
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- ODE-389Orphan-drug exclusivity (7 years)
in 2 yr 4 mo
- ODE-464Orphan-drug exclusivity (7 years)
in 4 yr 5 mo
- NPNew product exclusivity (3 years)
in 6 mo
- ODE-466Orphan-drug exclusivity (7 years)
in 4 yr 6 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9119863 | in 3 mo | U-3820 | |
| 8975243 | in 3 mo | U-3820 | |
| 8497258 | in 3 mo | U-3820 | |
| 11197822 | in 3 mo | Product | |
| 11413296 | in 3 mo | Product | |
| 8679545 | in 3 mo | Product | |
| 11357859 | in 2 yr 3 mo | U-3820 | |
| 10293052 | in 2 yr 3 mo | Product | |
| 8491932 | in 2 yr 9 mo | ProductU-3269 | |
| 9050368 | in 3 yr | Product | |
| 8324192 | in 3 yr | U-3820 | |
| 9192581 | in 5 yr 1 mo | ProductU-1325 | |
| 8895064 | in 5 yr 1 mo | Product | |
| 10660858 | in 5 yr 1 mo | Product | |
| 10307375 | in 5 yr 1 mo | Product | |
| 9132093 | in 5 yr 1 mo | Product | |
| 9707182 | in 10 yr 2 mo | ProductU-2554 | |
| 10172802 | in 10 yr 2 mo | U-2554 | |
| 11564934 | in 12 yr 7 mo | U-3820 | |
| 11260064 | in 12 yr 7 mo | Product | |
| 11896719 | in 16 yr 8 mo | U-3810 | |
| 12171882 | in 16 yr 8 mo | U-4085 | |
| 12311057 | in 16 yr 8 mo | ProductU-4085 | |
| 12171883 | in 16 yr 8 mo | Product |
Approval history
FDA approval span
First approval
33 yr ago
Most recent approval
2 yr 7 mo ago
Approvals span 1994–2024 across 32 FDA applications.
Brand (NDA) 1134%
Generic (ANDA) 2166%
Budesonide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
