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Last Updated: June 3, 2020

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ZETIA Drug Profile


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Which patents cover Zetia, 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 suppliers are listed for this compound. Additional details are available on the ezetimibe profile page.

US ANDA Litigation and Generic Entry Outlook for Zetia

A generic version of ZETIA was approved as ezetimibe by GLENMARK PHARMS LTD on June 26th, 2015.

  Start Trial

Drug patent expirations by year for ZETIA
Drug Prices for ZETIA

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Drug Sales Revenue Trends for ZETIA

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Recent Litigation for ZETIA

Identify potential future generic entrants

District Court Litigation
Case NameDate
MERCK SHARP & DOHME CORP. v. SANDOZ INC.2012-09-27
Takeda Pharmaceutical Co., Ltd. v. Dr. Reddy's Laboratories, LTD.2011-03-31
Takeda Pharmaceutical Co., LTD v. Handa Pharmaceuticals, LLC2011-02-23

See all ZETIA litigation

Pharmacology 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-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-[3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-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
ACT03511
AKOS005572111
AM84560
AMX10142
AR-270/43507897
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 anhydrate
Ezetimibe, >=98% (HPLC)
Ezetimibe, Pharmaceutical Secondary Standard; Certified Reference Material
Ezetimibe, United States Pharmacopeia (USP) Reference Standard
Ezetimibe(Zetia)
ezetimibum
Ezetrol
FT-0601590
GTPL6816
HMS2051K16
HMS2236A04
HMS3715D06
HSDB 7737
HY-17376
K-5098
KS-1170
LS-181801
MCULE-4417284526
MK-0653
MK0653
MLS000759443
MLS001424125
MLS006011921
NC00134
NCGC00095134-01
NCGC00263575-01
NCGC00263575-07
OLNTVTPDXPETLC-XPWALMASSA-N
Q417997
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
Paragraph IV (Patent) Challenges for ZETIA
Tradename Dosage Ingredient NDA Submissiondate
ZETIA TABLET;ORAL ezetimibe 021445 2006-10-25

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   Start Trial   Start Trial Y   Start Trial
Msd Intl Gmbh ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 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

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

Supplementary Protection Certificates for ZETIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 05C0040 France   Start Trial PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599 SZ 20/2003 Austria   Start Trial PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON
0720599 20/2003 Austria   Start Trial PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 1-24902 1-24904 20030415; FIRST REGISTRATION: DE 54486.00.00 - 54489.00.00 20021017
0720599 92545 Luxembourg   Start Trial PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
0720599 C300132 Netherlands   Start Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION: RVG 28626 20030418; FIRST REGISTRATION: DE 54486.00.00, 54487.00.00, 54488.00.00, 54489.00.00 20021017
0720599 SPC001/2005 Ireland   Start Trial SPC001/2005: 20050803, EXPIRES: 20190401
>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:

Express Scripts
Moodys
McKesson
Mallinckrodt
Boehringer Ingelheim
Colorcon

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