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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. Forty-one suppliers are listed for this compound.

Summary for budesonide

International Patents:	173
US Patents:	29
Tradenames:	9
Applicants:	18
NDAs:	24
Drug Master File Entries:	21
Suppliers / Packagers:	41
Bulk Api Vendors:	44
Clinical Trials:	292
Patent Applications:	7,585
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
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,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
Perrigo Pharma Intl	ENTOCORT EC	budesonide	CAPSULE;ORAL	021324-001	Oct 2, 2001	AB	RX	Yes	Yes
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006		RX	Yes	Yes					Y
Astrazeneca Pharms	PULMICORT RESPULES	budesonide	SUSPENSION;INHALATION	020929-001	Aug 8, 2000	AN	RX	Yes	No					Y
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006		RX	Yes	Yes					Y

Expired US Patents for budesonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Perrigo Pharma Intl	ENTOCORT EC	budesonide	CAPSULE;ORAL	021324-001	Oct 2, 2001
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

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
6,392,036	Dry heat sterilization of a glucocorticosteroid
6,030,604	Formulation for inhalation
7,410,652	Controlled release and taste masking oral pharmaceutical composition
9,737,489	Controlled release and taste masking oral pharmaceutical composition

International Patents for budesonide

Country	Document Number	Estimated Expiration
South Africa	9800078
Portugal	1183014
Czech Republic	9902555
Spain	2201456

Supplementary Protection Certificates for budesonide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/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