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Last Updated: December 6, 2019

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Ezetimibe - Generic Drug Details

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What are the generic drug sources for ezetimibe and what is the scope of patent protection?

Ezetimibe is the generic ingredient in four branded drugs 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, Msd Intl Gmbh, Ani Pharms Inc, Dr Reddys Labs Sa, and Msd Intl, and is included in twenty 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 is one tentative approval for this compound.

Drug Prices for ezetimibe

See drug prices for ezetimibe

Drug Sales Revenue Trends for ezetimibe

See drug sales revenues for ezetimibe

Recent Clinical Trials for ezetimibe

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

SponsorPhase
Inje UniversityPhase 4
Kyunghee University Medical CenterPhase 4
Ewha Womans University Seoul hospitalPhase 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

Generic filers with tentative approvals for EZETIMIBE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MG; 10MGTABLET; ORAL
  Start Trial  Start Trial10MG; 80MGTABLET; ORAL
  Start Trial  Start Trial10MG; 40MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Amneal Pharms Co EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 208831-001 Nov 21, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Alkem Labs Ltd EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 209222-003 Dec 22, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Pharms Ltd EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 208699-004 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

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   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 ezetimibe

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 SPC/GB05/010 United Kingdom   Start 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
0720599 03C0028 France   Start Trial PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
>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:

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Boehringer Ingelheim
Harvard Business School
Johnson and Johnson
Mallinckrodt
Moodys

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.