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Last Updated: November 20, 2019

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UCERIS Drug Profile

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Which patents cover Uceris, and when can generic versions of Uceris launch?

Uceris is a drug marketed by Valeant Pharms Intl and Salix and is included in two NDAs. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in seventeen countries.

The generic ingredient in UCERIS is budesonide. There are twenty-two drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Drug patent expirations by year for UCERIS
Drug Prices for UCERIS

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Drug Sales Revenue Trends for UCERIS

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Recent Clinical Trials for UCERIS

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

SponsorPhase
Perrigo CompanyPhase 1

See all UCERIS clinical trials

Recent Litigation for UCERIS

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
Cosmo Technologies Limited v. Mylan Pharmaceuticals Inc.2016-03-15

See all UCERIS litigation

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

See all UCERIS litigation

Pharmacology for UCERIS
Synonyms for UCERIS
(+)-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
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 (TN)
Ultesa
VOVIALXJUBGFJZ-KWVAZRHASA-N
Paragraph IV (Patent) Challenges for UCERIS
Tradename Dosage Ingredient NDA Submissiondate
UCERIS TABLET, EXTENDED RELEASE;ORAL budesonide 203634 2013-03-11

US Patents and Regulatory Information for UCERIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms Intl UCERIS budesonide AEROSOL, FOAM;RECTAL 205613-001 Oct 7, 2014 RX Yes Yes   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
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
Salix UCERIS budesonide TABLET, EXTENDED RELEASE;ORAL 203634-001 Jan 14, 2013 AB 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

Supplementary Protection Certificates for UCERIS

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:

McKesson
Boehringer Ingelheim
Harvard Business School
Dow
Express Scripts
McKinsey

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.