You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Last Updated: February 18, 2020

DrugPatentWatch Database Preview

Budesonide - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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

Budesonide is the generic ingredient in ten branded drugs marketed by Valeant Pharms Intl, Astrazeneca, Sun Pharma Global, Alvogen, Amneal Pharms, Appco, 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.

Summary for budesonide

International Patents:	60
US Patents:	32
Tradenames:	10
Applicants:	23
NDAs:	27
Drug Master File Entries:	22
Suppliers / Packagers:	36
Bulk Api Vendors:	52
Clinical Trials:	333
Patent Applications:	7,854
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for budesonide
Drug Sales Revenues:	Drug sales revenues for budesonide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for budesonide
DailyMed Link:	budesonide at DailyMed

See drug prices for budesonide

Drug Sales Revenue Trends for budesonide

See drug sales revenues for budesonide

Recent Clinical Trials for budesonide

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

Sponsor	Phase
St. Justine's Hospital	N/A
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Sanotize Research and Development corp.	Phase 2

See all budesonide clinical trials

Recent Litigation for budesonide

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Biogen International GmbH v. Banner Life Sciences LLC	2018-12-27
VALEANT PHARMACEUTICALS INTERNATIONAL v. SUN PHARMACEUTICAL INDUSTRIES, LTD.	2018-12-17
Valeant Pharmaceuticals International v. Actavis Laboratories FL, Inc.	2018-08-22

See all budesonide litigation

PTAB Litigation

Petitioner	Date
	2017-10-20
	2017-03-09

See all budesonide litigation

Pharmacology for budesonide

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for budesonide

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Start Trial
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	Start Trial	Start Trial				Start Trial
Actavis Labs Fl Inc	BUDESONIDE	budesonide	TABLET, EXTENDED RELEASE;ORAL	205457-001	Jul 3, 2018	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	AB	RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	AB	RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006		RX	Yes	Yes	Start Trial	Start Trial			Y	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

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006	Start Trial	Start Trial
Astrazeneca	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006	Start Trial	Start Trial
Valeant Pharms Intl	UCERIS	budesonide	AEROSOL, FOAM;RECTAL	205613-001	Oct 7, 2014	Start Trial	Start Trial
Astrazeneca Pharms	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-002	Aug 8, 2000	Start Trial	Start Trial
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-003	Jun 24, 1997	Start Trial	Start Trial
Astrazeneca Pharms	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for budesonide

Subscribe to access the full database, or Start Trial
Country	Patent Number	Estimated Expiration
Japan	2001523638	Start Trial
European Patent Office	3346996	Start Trial
Norway	331642	Start Trial
Italy	MI991317	Start Trial
Japan	5279850	Start Trial
Spain	2214749	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for budesonide

Subscribe to access the full database, or Start Trial
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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

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.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.