Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

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Budesonide - Generic Drug Details

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What are the generic sources for budesonide and what is the scope of freedom to operate?

Budesonide is the generic ingredient in ten branded drugs marketed by Valeant Pharms Intl, Astrazeneca, Sun Pharma Global, Alvogen, Amneal Pharms, Appco Pharma Llc, Barr Labs Div Teva, Mayne Pharma, Mylan, Sciecure Pharma Inc, Zydus Pharms, Perrigo Pharma Intl, Apotex Inc, Astrazeneca Pharms, Cipla, Impax Labs Inc, Lupin Atlantis, Nephron, Sandoz Inc, Teva Pharms, Teva Pharms Usa, Actavis Labs Fl Inc, and Salix, and is included in twenty-seven NDAs. There are thirty-two patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Budesonide has sixty patent family members in twenty-eight countries.

There are twenty-two drug master file entries for budesonide. Thirty-six suppliers are listed for this compound.

Drug Prices for budesonide

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Drug Sales Revenue Trends for budesonide

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Recent Clinical Trials for budesonide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
St. Justine's HospitalN/A
Sanotize Research and Development corp.Phase 2
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionPhase 4

See all budesonide clinical trials

Recent Litigation for budesonide

Identify potential future generic entrants

District Court Litigation
Case NameDate
VALEANT PHARMACEUTICALS INTERNATIONAL v. SUN PHARMACEUTICAL INDUSTRIES, LTD.2018-12-17
Valeant Pharmaceuticals International v. Actavis Laboratories FL, Inc.2018-08-22
Salix Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-27

See all budesonide litigation

PTAB Litigation
PetitionerDate
Argentum Pharmaceuticals LLC2017-10-20
Mylan Pharmaceuticals Inc.2017-03-09

See all budesonide litigation

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
Paragraph IV (Patent) Challenges for BUDESONIDE
Tradename Dosage Ingredient NDA Submissiondate
UCERIS TABLET, EXTENDED RELEASE;ORAL budesonide 203634 2013-03-11
PULMICORT RESPULES SUSPENSION;INHALATION budesonide 020929 2010-05-28
ENTOCORT EC CAPSULE;ORAL budesonide 021324 2008-02-01
RHINOCORT ALLERGY SPRAY, METERED;NASAL budesonide 020746 2007-05-14
PULMICORT RESPULES SUSPENSION;INHALATION budesonide 020929 2005-09-15

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
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sun Pharma Global ORTIKOS budesonide CAPSULE, EXTENDED RELEASE;ORAL 211929-002 Jun 13, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cipla BUDESONIDE budesonide SUSPENSION;INHALATION 205710-001 Nov 16, 2017 AN RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for budesonide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006   Start Trial   Start Trial
Astrazeneca PULMICORT FLEXHALER budesonide POWDER, METERED;INHALATION 021949-002 Jul 12, 2006   Start Trial   Start Trial
Astrazeneca PULMICORT budesonide POWDER, METERED;INHALATION 020441-002 Jun 24, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for budesonide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0613371 SPC/GB02/033 United Kingdom   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
AstraZeneca
Dow
Express Scripts
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.