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FDA Orange Book · active-ingredient family

Budesonide

Budesonide is approved as 11 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:EOHILIA · NDA 213976

11

Brand (NDA)

21

Generics (ANDA)

24

Listed patents

4

Exclusivity periods

Brand (NDA) products · aerosol, foam, aerosol, metered, capsule, delayed release, powder, metered, spray, metered, suspension, tablet, extended release

ProductApplicantApplicationTEApproved
EOHILIARLDTAKEDA PHARMS USANDA 213976—Feb 09, 2024
TARPEYORLDCALLIDITASNDA 215935—Dec 15, 2021
ORTIKOSRLD×2SUN PHARM INDS INCNDA 211929—Jun 13, 2019
RHINOCORT ALLERGYRLDKENVUE BRANDSNDA 020746—Mar 23, 2015
UCERISRLDSALIXNDA 205613ABOct 07, 2014
UCERISRLDSALIXNDA 203634ABJan 14, 2013
PULMICORT FLEXHALERRLD×2CHEPLAPHARMNDA 021949—Jul 12, 2006
ENTOCORT ECRLDPADAGIS USNDA 021324ABOct 02, 2001
PULMICORT RESPULESRLD×3ASTRAZENECANDA 020929ANAug 08, 2000
PULMICORT×2ASTRAZENECANDA 020441—Jun 24, 1997
RHINOCORTASTRAZENECANDA 020233—Feb 14, 1994

Generic (ANDA) products (21)

ProductApplicantApplicationTEApproved
BUDESONIDEEUGIA PHARMAANDA 216667ANNov 29, 2023
BUDESONIDEPADAGIS ISRAELANDA 215328ABApr 12, 2023
BUDESONIDE×3SUN PHARMANDA 211922ANApr 14, 2021
BUDESONIDEMYLANANDA 208851ABSep 17, 2020
BUDESONIDELUPINANDA 210897ANNov 09, 2018
BUDESONIDEACTAVIS LABS FL INCANDA 205457ABJul 03, 2018
BUDESONIDE×3CIPLAANDA 205710ANNov 16, 2017
BUDESONIDESCIECURE PHARMA INCANDA 209041—Sep 28, 2017
BUDESONIDEAMNEAL PHARMSANDA 206200ABJul 31, 2017
BUDESONIDEZYDUS PHARMSANDA 206134ABMay 04, 2017
BUDESONIDERISINGANDA 207367ABApr 07, 2017
BUDESONIDENATCOANDA 206724—Nov 23, 2016
BUDESONIDEDR REDDYS LABS SAANDA 206623ABApr 08, 2016
BUDESONIDETEVA PHARMS USAANDA 204548ANMar 08, 2016
BUDESONIDEAPOTEXANDA 078949—Nov 20, 2015
BUDESONIDEBARR LABS DIV TEVAANDA 090379—Apr 02, 2014
BUDESONIDE×3SANDOZANDA 201966—Sep 27, 2013
BUDESONIDE×2IMPAX LABS INCANDA 078404ANJul 31, 2012
BUDESONIDEAUROBINDO PHARMA USAANDA 090410ABMay 16, 2011
BUDESONIDE×2NEPHRONANDA 078202ANMar 30, 2009
BUDESONIDE×2TEVA PHARMSANDA 077519ANNov 18, 2008

Marketing exclusivity (4)

  • ODE-389Orphan-drug exclusivity (7 years)

    Dec 15, 2028

    in 2 yr 6 mo

  • ODE-464Orphan-drug exclusivity (7 years)

    Dec 20, 2030

    in 4 yr 7 mo

  • NPNew product exclusivity (3 years)

    Feb 09, 2027

    in 8 mo

  • ODE-466Orphan-drug exclusivity (7 years)

    Feb 09, 2031

    in 4 yr 9 mo

Listed patents (24)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9119863Nov 09, 2026in 5 mo
U-3820
8975243Nov 09, 2026in 5 mo
U-3820
8497258Nov 09, 2026in 5 mo
U-3820
11197822Nov 09, 2026in 5 mo
Product
11413296Nov 09, 2026in 5 mo
Product
8679545Nov 09, 2026in 5 mo
Product
11357859Nov 12, 2028in 2 yr 5 mo
U-3820
10293052Nov 22, 2028in 2 yr 6 mo
Product
8491932May 07, 2029in 2 yr 11 mo
ProductU-3269
9050368Aug 01, 2029in 3 yr 2 mo
Product
8324192Aug 03, 2029in 3 yr 2 mo
U-3820
9192581Sep 07, 2031in 5 yr 4 mo
ProductU-1325
8895064Sep 07, 2031in 5 yr 4 mo
Product
10660858Sep 07, 2031in 5 yr 4 mo
Product
10307375Sep 07, 2031in 5 yr 4 mo
Product
9132093Sep 07, 2031in 5 yr 4 mo
Product
9707182Sep 09, 2036in 10 yr 5 mo
ProductU-2554
10172802Sep 09, 2036in 10 yr 5 mo
U-2554
11564934Jan 10, 2039in 12 yr 9 mo
U-3820
11260064Jan 10, 2039in 12 yr 9 mo
Product
11896719Jan 23, 2043in 16 yr 10 mo
U-3810
12171882Jan 23, 2043in 16 yr 10 mo
U-4085
12311057Jan 23, 2043in 16 yr 10 mo
ProductU-4085
12171883Jan 23, 2043in 16 yr 10 mo
Product

Budesonide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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