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Last Updated: December 6, 2019

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EZETIMIBE Drug Profile

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When do Ezetimibe patents expire, and when can generic versions of Ezetimibe launch?

Ezetimibe is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Ohm Labs Inc, Sandoz Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms, Watson Labs Teva, Ani Pharms Inc, and Dr Reddys Labs Sa. and is included in nineteen NDAs.

The generic ingredient in EZETIMIBE is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the ezetimibe; simvastatin profile page.

Drug patent expirations by year for EZETIMIBE
Drug Prices for EZETIMIBE

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Drug Sales Revenue Trends for EZETIMIBE

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Recent Clinical Trials for EZETIMIBE

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

SponsorPhase
Ewha Womans University Seoul hospitalPhase 4
Severance HospitalPhase 4
Korea UniversityPhase 4

See all EZETIMIBE clinical trials

Recent Litigation for EZETIMIBE

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 EZETIMIBE litigation

Pharmacology for EZETIMIBE
Medical Subject Heading (MeSH) Categories for EZETIMIBE
Synonyms for EZETIMIBE
(-)-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 (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
Zetia ;Ezetrol
Zetia (TN)
Zient
ZINC3810860
Paragraph IV (Patent) Challenges for EZETIMIBE
Tradename Dosage Ingredient NDA Submissiondate
ZETIA TABLET;ORAL ezetimibe 021445 2006-10-25

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
Dr Reddys Labs Sa EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 200909-004 Apr 26, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 201890-004 Apr 26, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms Ltd EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 208699-001 Jun 27, 2019 AB RX No No   Start Trial   Start Trial   Start 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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