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Teva
Federal Trade Commission
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Accenture
Chinese Patent Office
Cipla

Generated: June 20, 2018

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Budesonide - Generic Drug Details

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What are the generic drug sources for budesonide and what is the scope of budesonide patent protection?

Budesonide
is the generic ingredient in nine branded drugs marketed by Valeant Pharms Intl, Astrazeneca, Alvogen Malta, Amneal Pharms, Appco Pharma Llc, Barr Labs Div Teva, Mayne Pharma, Mylan, Sciecure Pharma Inc, Zydus Pharms Usa Inc, Perrigo Pharma Intl, Apotex Inc, Astrazeneca Pharms, Cipla Ltd, Impax Labs Inc, Sandoz Inc, Teva Pharms, and Teva Pharms Usa, and is included in twenty-four NDAs. There are twenty-nine patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Budesonide has one hundred and seventy-three patent family members in forty countries.

There are twenty-one drug master file entries for budesonide. Thirty-nine suppliers are listed for this compound.
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,8R,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)-5-HYDROXY-6B-(2-HYDROXY-ACETYL)-4A,6A-DIMETHYL-8-PROPYL-4A,4B,5,6,6A,6B,9A,10,10A,10B,11,12-DODECAHYDRO-7,9-DIOXA-PENTALENO[2,1-A]PHENANTHREN-2-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
(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
(S)-16alpha,17-(Butylidenedioxy)-11beta,21-dihydroxypregna-1,4-diene-3,20-dione
1,4-PREGNADIEN-(R, S)-11-BETA, 16-ALPHA, 17,21-TETROL-3,20-DIONE CYCLIC 16,17 ACETAL
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
16alpha-,17alpha-butylidenedioxypregna-1,4-diene-11beta-,21-diol-3,20-dione
16alpha(R),17-(Butylidenebis(oxy))-11beta,21-dihydroxypregna-1,4-diene-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
barazone
BBC/768
BDBM50354850
Bidien
Bio-0010
BPBio1_000523
BRD-A34299591-001-03-4
BSPBio_000475
Budecort Inhaler
Budenofalk
Budesomide
Budeson
Budesonide (JAN/USAN/INN)
Budesonide [USAN:INN:BAN:JAN]
Budesonide Easyhaler
Budesonide MMX
Budesonide, >=99%
Budesonide, European Pharmacopoeia (EP) Reference Standard
Budesonide, pharmaceutical secondary standard; traceable to USP, PhEur and BP
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
D0Y7IU
DB01222
Dexbudesonide [INN]
DTXSID8020202
EINECS 257-139-7
Eltair
Entocort
Entocort (TN)
Entocort EC
Entocort EC (TN)
Epitope ID:161750
EU-0100174
Fvolir
Giona Easyhaler
GionaEasyhaler
GTPL7434
HMS1569H17
HMS2096H17
HMS2232D17
HMS3259H07
HMS3260D09
Horacort
HSDB 8279
HY-13580
Inflammide
J-504150
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
Noex (TN)
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(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 Nebuamp
Pulmicort Respules
Pulmicort Topinasal
Pulmicort turbuhaler
Q-101375
Respules
Rhinocort
Rhinocort (TN)
Rhinocort Allergy
Rhinocort alpha
Rhinocort Aqua
Rhinocort Turbuhaler
Rhinocort, Pulmicort , Entocort, Symbicort, Noex. Entocort EC, Budesonide
RL03890
S 1320
S-1320
SC-71383
SCHEMBL4096
SMR000058337
SPBio_002396
Spirocort
SR-01000000101
SR-01000000101-2
ST24046248
Tox21_500174
Turbuhaler
Uceris
Uceris (TN)
Ultesa
Unit dosebudesonide
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
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Valeant Pharms Intl UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Appco Pharma Llc BUDESONIDE budesonide CAPSULE;ORAL 207367-001 Apr 7, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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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Expired US Patents for budesonide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms PULMICORT RESPULES budesonide SUSPENSION;INHALATION 020929-003 Aug 8, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-001 Jul 12, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca PULMICORT budesonide POWDER, METERED;INHALATION 020441-002 Jun 24, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca PULMICORT budesonide POWDER, METERED;INHALATION 020441-002 Jun 24, 1997 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for budesonide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,030,604 Formulation for inhalation ➤ Try a Free Trial
6,392,036 Dry heat sterilization of a glucocorticosteroid ➤ Try a Free Trial
7,410,652 Controlled release and taste masking oral pharmaceutical composition ➤ Try a Free Trial
8,029,823 Controlled release and taste masking oral pharmaceutical composition ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for budesonide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/033 United Kingdom ➤ Try a Free Trial PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Moodys
Johnson and Johnson
Citi
Teva
Cerilliant
QuintilesIMS
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