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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, Barr Labs Div Teva, Mayne Pharma, Mylan, Rising Pharms, Sciecure Pharma Inc, Zydus Pharms Usa Inc, Perrigo Pharma Intl, Apotex Inc, Astrazeneca Pharms, Cipla, Impax Labs Inc, Lupin Atlantis, Sandoz Inc, Teva Pharms, Teva Pharms Usa, and Actavis Labs Fl Inc, and is included in twenty-six 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 one hundred and seventy-three patent family members in forty countries.

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

Summary for budesonide

International Patents:	173
US Patents:	32
Tradenames:	9
Applicants:	20
NDAs:	26
Drug Master File Entries:	22
Suppliers / Packagers:	40
Bulk Api Vendors:	50
Clinical Trials:	309
Patent Applications:	7,584
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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

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

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	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006		RX	Yes	Yes			Y
Teva Pharms	BUDESONIDE	budesonide	SUSPENSION;INHALATION	077519-002	Nov 18, 2008	AN	RX	No	No
Valeant Pharms Intl	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	AB	RX	Yes	Yes			Y
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006		RX	Yes	Yes					Y
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006		RX	Yes	Yes					Y

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
Astrazeneca	PULMICORT	budesonide	POWDER, METERED;INHALATION	020441-002	Jun 24, 1997
Astrazeneca	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006
Valeant Pharms Intl	UCERIS	budesonide	AEROSOL, FOAM;RECTAL	205613-001	Oct 7, 2014
Astrazeneca	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006

International Patents for budesonide

Country	Patent Number	Estimated Expiration
Japan	2003501457
China	1243434
Japan	2001517981
Poland	334527
Spain	2201456

Supplementary Protection Certificates for budesonide

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