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Generated: April 19, 2019

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BUDESONIDE Drug Profile

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When do Budesonide patents expire, and when can generic versions of Budesonide launch?

Budesonide is a drug marketed by Alvogen Malta, Amneal Pharms, Appco Pharma Llc, Barr Labs Div Teva, Mayne Pharma, Mylan, Sciecure Pharma Inc, Zydus Pharms Usa Inc, Apotex Inc, Cipla, Impax Labs Inc, Lupin Atlantis, Sandoz Inc, Teva Pharms, Teva Pharms Usa, and Actavis Labs Fl Inc. and is included in seventeen NDAs.

The generic ingredient in BUDESONIDE is budesonide. There are twenty-two drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Drug patent expirations by year for BUDESONIDE
Pharmacology for BUDESONIDE
Medical Subject Heading (MeSH) Categories for BUDESONIDE
Synonyms for BUDESONIDE
(+)-16alpha,17alpha-Butylidenedioxy-11beta,21-dihydroxy-1,4-pregnadiene-3,20-dione
(11-beta,16-alpha)-16,17-(Butylidenebis(oxy))-11,21-dihydroxypregna-1,4-diene-3,20-dione
(11?,16?)-16,17-[Butylidenebis(oxy)]-11,21-dihydroxypregna-1,4-diene-3,20-dione
(11|A,16|A)-16,17-[Butylidenebis(oxy)]-11,21-dihydroxypregna-1,4-diene-3,20-dione
(11beta,16alpha)-16,17-(Butylidenebis(oxy))-11,21-dihydroxypregna-1,4-diene-3,20-dione
(1S,2S,4R,8S,9S,11S,12S,13R)-11-hydroxy-8-(2-hydroxyacetyl)-9,13-dimethyl-6-propyl-5,7-dioxapentacyclo[10.8.0.0;{2,9}.0;{4,8}.0;{13,18}]icosa-14,17-dien-16-one
(4aR,4bS,5S,6aS,6bS,9aR,10aS,10bS)-5-hydroxy-6b-(hydroxyacetyl)-4a,6a-dimethyl-8-propyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
(4aR,4bS,5S,6aS,6bS,9aR,10aS,10bS)-6b-Glycoloyl-5-hydroxy-4a,6a-dimethyl-8-propyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
(6aR,6bS,7S,8aS,8bS,11aR,12aS,12bS)-7-hydroxy-8b-(2-hydroxyacetyl)-6a,8a-dimethyl-10-propyl-1,2,6a,6b,7,8,8a,8b,11a,12,12a,12b-dodecahydro-4H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-4-one
(6aR,6bS,7S,8aS,8bS,11aR,12aS,12bS)-7-hydroxy-8b-(2-hydroxyacetyl)-6a,8a-dimethyl-10-propyl-6a,6b,7,8,8a,8b,11a,12,12a,12b-decahydro-1H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-4(2H)-one
(R,S)-11b,16a,17,21,tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with buty raldehyde
(R)-Budesonide
(RS)-(11beta,16alpha)-16,17-[Butylidenebis(oxy)]-11,21-dihydroxypregna-1,4-diene-3,20-dione
(RS)-11beta,16alpha,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde
11beta,21-dihydroxy-16alpha,17alpha-(butane-1,1-diyldioxy)pregna-1,4-diene-3,20-dione
16-alpha,17-alpha-Butylidenedioxy-11-beta,21-dihydroxy-1,4-pregnadiene-3,20-dione
16,17-Butylidenebis(oxy)-11-,21-dihydroxypregna-1,4-diene-3,20-dione
16,17-Butylidenebis(oxy)-11,21-dihydroxypregna-1,4-diene-3,20-dione
16?,17-[(1RS)-Butylidenebis(oxy)]-11?,21-dihydroxypregna-1,4-diene-3,20-dione
16a(R),17-(Butylidenebis(oxy))-11b,21-dihydroxypre
16A(R),17-(BUTYLIDENEBIS(OXY))-11B,21-DIHYDROXYPREGNA-1,4-DIENE-3,20-DIONE
16alpha-,17alpha--butylidenedioxypregna-1,4-diene-11beta-,21-diol-3,20-dione
333B223
51333-22-3
51372-29-3
5301-EP2270008A1
5301-EP2280006A1
5301-EP2281563A1
5301-EP2281813A1
5301-EP2281815A1
5301-EP2281819A1
5301-EP2292617A1
5301-EP2292619A1
5301-EP2295402A2
5301-EP2295408A1
5301-EP2301933A1
5301-EP2305640A2
5301-EP2305659A1
5301-EP2308562A2
5301-EP2311818A1
5301-EP2311827A1
5301-EP2314590A1
5301-EP2316459A1
5301-EP2371811A2
AB03148
AC-4697
ACN-043365
ACT03247
AKOS015969655
API0024660
B 7777
B3909
BBC/768
BCP05589
BDBM50354850
Bidien
BPBio1_000523
BRD-A34299591-001-03-4
BSPBio_000475
Budecort Inhaler
Budenofalk
Budesomide
Budeson
Budesonide (JAN/USAN/INN)
Budesonide (Mixture of Diastereomers)
Budesonide [USAN:INN:BAN:JAN]
Budesonide Easyhaler
Budesonide MMX
Budesonide, >=99%
Budesonide, European Pharmacopoeia (EP) Reference Standard
Budesonide, Pharmaceutical Secondary Standard; Certified Reference Material
Budesonide, United States Pharmacopeia (USP) Reference Standard
Budesonido
Budesonido [INN-Spanish]
Budesonidum
Budesonidum [INN-Latin]
Budiair
C25H34O6
CCG-204269
CCRIS 5230
CHEBI:3207
CHEMBL1370
Cortivent
CPD000058337
CS-2063
D00246
DB01222
DTXSID8020202
EINECS 257-139-7
Eltair
Entocort
Entocort EC
Entocort EC (TN)
Epitope ID:161750
EU-0100174
Fvolir
Giona Easyhaler
GTPL7434
HMS1569H17
HMS2096H17
HMS2232D17
HMS3259H07
HMS3260D09
HMS3713H17
Horacort
HSDB 8279
HY-13580
Inflammide
J-504150
Jorveza
KS-1162
Lopac0_000174
LP00174
LS-7235
MAP-0010
MFCD00083259
Micronyl
Miflonide
MLS000028507
MLS001077323
MLS002207112
MolPort-002-529-265
NC00626
NCGC00021318-05
NCGC00021318-06
NCGC00089747-04
NCGC00260859-01
Nebuampul
Noex
Opera_ID_1696
Preferid
Pregna-1,4-diene-3,20-dione, 16,17-(butylidenebis(oxy))-11,21-dihydroxy-, (11-beta,16-alpha)-
Pregna-1,4-diene-3,20-dione, 16,17-[butylidenebis(oxy)]-11,21-dihydroxy-, (11.beta.,16.alpha.)-
Pregna-1,4-diene-3,20-dione, 16,17-butylidenebis(oxy)-11,21-dihydroxy-, (11beta,16alpha(R))-, and 16alpha,17-((S)-Butylidenebis(oxy))-11beta,21-dihydroxypregna-1,4-diene-3,20-dione
Pregna-1,4-diene-3,20-dione,16,17-(butylidenebis(oxy))-11,21-dihydroxy-, (11beta,16alpha)-
Prestwick_840
Prestwick0_000518
Prestwick1_000518
Prestwick2_000518
Prestwick3_000518
Pulmaxan
Pulmaxan turbohaler
Pulmicort
Pulmicort (TN)
Pulmicort Flexhaler
Pulmicort Respules
Pulmicort Topinasal
Pulmicort turbuhaler
Q-101375
Respules
Rhinocort
Rhinocort (TN)
Rhinocort Allergy
Rhinocort alpha
Rhinocort Aqua
RL03890
S 1320
S-1320
SC-71383
SCHEMBL4096
SMR000058337
SPBio_002396
Spirocort
SR-01000000101
SR-01000000101-2
SR-01000000101-6
ST24046248
Tox21_500174
Turbuhaler
Uceris
Uceris (TN)
Ultesa
VOVIALXJUBGFJZ-KWVAZRHASA-N

US Patents and Regulatory Information for BUDESONIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alvogen Malta BUDESONIDE budesonide CAPSULE;ORAL 206724-001 Nov 23, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz Inc BUDESONIDE budesonide SUSPENSION;INHALATION 201966-003 Sep 27, 2013 AN RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Labs Fl Inc BUDESONIDE budesonide TABLET, EXTENDED RELEASE;ORAL 205457-001 Jul 3, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sciecure Pharma Inc BUDESONIDE budesonide CAPSULE;ORAL 209041-001 Sep 28, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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