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Generated: April 21, 2019

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ZETIA Drug Profile

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When do Zetia patents expire, and what generic alternatives are available?

Zetia is a drug marketed by Msd Intl Gmbh and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ZETIA is ezetimibe. There are twenty-four drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ezetimibe profile page.

Drug patent expirations by year for ZETIA
Pharmacology for ZETIA
Medical Subject Heading (MeSH) Categories for ZETIA
Synonyms for ZETIA
(-)-Sch 58235
(3R,4S)-1-(4-fluorophenyl)-3-((S)-3-(4-fluorophenyl)-
(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))-
2-Azetidinone, 1-(4-fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)-, (3R,4S)-
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
3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one
AB0011316
AB00639916_09
AB00639916-06
AB00639916-08
AB2000199
ABP001091
AC-1057
AC1L442L
ACT03511
AK-33567
AKOS005572111
AM84560
AMX10142
AN-5188
BC216471
BDBM50371521
BRD-K42260897-001-09-2
C24H21F2NO3
CAS-163222-33-1
CCG-100884
CHEBI:49040
CHEMBL1138
CPD000466334
CS-1016
D01966
DB00973
DSSTox_CID_24223
DSSTox_GSID_44223
DSSTox_RID_80127
DTXSID1044223
EOR26LQQ24
EX-A795
Ezedoc
ezetimiba
Ezetimibe
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
HMS2051K16
HMS2236A04
HMS3715D06
HSDB 7737
HY-17376
K-5098
KS-1170
LS-181801
MCULE-4417284526
MK-0653
MLS000759443
MLS001424125
MLS006011921
MolPort-005-938-627
NC00134
NCGC00095134-01
NCGC00263575-01
NCGC00263575-07
OLNTVTPDXPETLC-XPWALMASSA-N
RL02093
s1655
SAM001246623
SC-17354
Sch 58235
SCH-58235
SCH58235
SCHEMBL2871
SMR000466334
STK640490
Tox21_111443
Tox21_111443_1
UNII-EOR26LQQ24
Z1550648770
Zetia ;Ezetrol
Zetia (TN)
Zient
ZINC3810860

US Patents and Regulatory Information for ZETIA

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 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
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 ZETIA

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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Paragraph IV (Patent) Challenges for ZETIA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 10 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for ZETIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 03C0028 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
0720599 300688 Netherlands ➤ Try a Free Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NATIONAL REGISTRATION NO/DATE: RVG114002-004 20140811; FIRST REGISTRATION: NO 13-9663 - 9665 20140724
0720599 SPC/GB03/023 United Kingdom ➤ Try a Free Trial PRODUCT NAME: EZETIMIBE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: DE 54486.00.00 20021017; DE 54488.00.00 20021017; DE 54487.00.00 20021017; DE 54489.00.00 20021017; UK PL 19945/0001 20030404; UK PL 19945/0002 20030404
0720599 05C0040 France ➤ Try a Free Trial PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599 92544 Luxembourg ➤ Try a Free Trial PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Deloitte
Johnson and Johnson
Argus Health
Covington

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