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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Covington
Queensland Health
Federal Trade Commission
QuintilesIMS
Julphar
Argus Health
Fish and Richardson
Moodys

Generated: May 23, 2018

DrugPatentWatch Database Preview

Ezetimibe - Generic Drug Details

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

Ezetimibe
is the generic ingredient in four branded drugs marketed by Alkem Labs Ltd, Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Ohm Labs Inc, Sandoz Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms Usa Inc, Msd Intl Gmbh, Dr Reddys Labs Sa, Impax Labs Inc, and Msd Intl, and is included in seventeen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ezetimibe has two hundred and thirty-five patent family members in thirty-eight countries.

There are twenty-four drug master file entries for ezetimibe. Twenty-two suppliers are listed for this compound. There are five tentative approvals for this compound.
Pharmacology for ezetimibe
Medical Subject Heading (MeSH) Categories for ezetimibe
Synonyms for ezetimibe
(-)-Sch 58235
(1-(4-fluorophenyl)-(3R)-(3-(4-fluorophenyl)-(3S)-hydroxypropyl)-(4S)-(4-hydroxyphenyl)-2-azetidinone)
(3R,4S)-1-(4-fluorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one
(3R,4S)-1-(4-fluorophenyl)-3-[(3 S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one
(3R,4S)-1-(4-fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxy-propyl]-4-(4-hydroxyphenyl)azetidin-2-one
(3R,4S)-1-(4-fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one
(3R,4S)-1-(4-Fluorophenyl)-3-[(S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)-azetidin-2-one
(3R,4S)-1-(p-Fluorophenyl)-3-((3S)-3-(p-fluorophenyl)-3-hydroxypropyl)-4-(p-hydroxyphenyl)-2-azetidinone
1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-(4-hydroxyphenyl)-2-azetidione
1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone
163222-33-1
2-Azetidinone, 1-(4-fluorophenyl)-3-((3S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)-, (3R,4S)-
2-Azetidinone, 1-(4-fluorophenyl)-3-(3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)-, (3R-(3alpha(S*),4beta))-
222E331
28055-EP2272841A1
28055-EP2280001A1
28055-EP2287165A2
28055-EP2287166A2
28055-EP2292620A2
28055-EP2294052A1
28055-EP2295422A2
28055-EP2298742A1
28055-EP2298769A1
28055-EP2298776A1
28055-EP2301923A1
28055-EP2301936A1
28055-EP2308878A2
28055-EP2314588A1
AB0011316
AB00639916_09
AB00639916-06
AB00639916-08
AB2000199
ABP001091
AC-1057
AC1L442L
ACT03511
AKOS005572111
AM84560
AMX10142
AN-5188
BC216471
BDBM50371521
C24H21F2NO3
CAS-163222-33-1
CCG-100884
CHEBI:49040
CHEMBL1138
CPD000466334
CS-1016
D01966
D09LWS
DB00973
DR002439
DSSTox_CID_24223
DSSTox_GSID_44223
DSSTox_RID_80127
DTXSID1044223
EOR26LQQ24
Essex brand of ezetimibe
EX-A795
Ezedoc
ezentia
ezetimib
ezetimiba
Ezetimibe (JAN/USAN/INN)
Ezetimibe (Zetia)
Ezetimibe [USAN:INN:BAN]
Ezetimibe [USAN:INN]
Ezetimibe, >=98% (HPLC)
Ezetimibe, Pharmaceutical Secondary Standard; Certified Reference Material
Ezetimibe, United States Pharmacopeia (USP) Reference Standard
ezetimibum
Ezetrol
FT-0601590
GTPL6816
HE316388
HMS2051K16
HMS2236A04
HSDB 7737
HY-17376
Inegy (TN)
K-5098
KS-1170
LS-181801
MCULE-4417284526
Merck brand of ezetimibe
MFCD00937872
MK-0653
MLS000759443
MLS001424125
MLS006011921
MolPort-005-938-627
MSD brand of ezetimibe
NC00134
NCGC00095134-01
NCGC00263575-01
OLNTVTPDXPETLC-XPWALMASSA-N
RL02093
s1655
SAM001246623
SC-17354
Sch 58235
SCH-58235
SCH58235
SCHEMBL2871
Schering-Plough brand of ezetimibe
SMR000466334
STK640490
STOCK6S-73750
Tox21_111443
Tox21_111443_1
UNII-EOR26LQQ24
Vytorin (TN)
Z1550648770
Zetia
Zetia , Ezetrol, Ezetimibe
Zetia ;Ezetrol
Zetia (TN)
Zient
ZINC3810860
Tentative approvals for EZETIMIBE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial10MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial10MG; 80MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial10MG; 40MGTABLET; ORAL

US Patents and Regulatory Information for ezetimibe

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msd Intl Gmbh ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-003 Jul 23, 2004 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc EZETIMIBE ezetimibe TABLET;ORAL 208332-001 Jun 12, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amneal Pharms Co EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 208831-003 Nov 21, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ezetimibe

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Intl Gmbh ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Intl Gmbh ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Intl Gmbh ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Intl Gmbh ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for ezetimibe

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
7,056,906 Combinations of hormone replacement therapy composition(s) and sterol absorption inhibitor(s) and treatments for vascular conditions in post-menopausal women ➤ Try a Free Trial
6,982,251 Substituted 2-azetidinones useful as hypocholesterolemic agents ➤ Try a Free Trial
7,071,181 Methods and therapeutic combinations for the treatment of diabetes using sterol absorption inhibitors ➤ Try a Free Trial
7,053,080 Methods and therapeutic combinations for the treatment of obesity using sterol absorption inhibitors ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ezetimibe

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0028 France ➤ Try a Free Trial PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
C/GB05/010 United Kingdom ➤ Try a Free Trial PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411
03/014 Ireland ➤ Try a Free Trial PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: 1091/1/1 00040127; FIRST REGISTRATION NO/DATE: EU: DE 54489.00.00 54486.00.00 54488.00.00 54487.00.00 20021017; PAEDIATRIC INVESTIGATION PLAN: P/0061/2012
2014 00050 Denmark ➤ Try a Free Trial PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Cerilliant
Queensland Health
Federal Trade Commission
Dow
AstraZeneca
Express Scripts
Chubb
Merck

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