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Last Updated: November 2, 2024

Ezetimibe - Generic Drug Details


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

Ezetimibe is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Ohm Labs Inc, Orient Pharma, Rising, Sandoz, Sciegen Pharms Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms, Organon, Althera Pharms, Ani Pharms, Aurobindo Pharma Usa, and Dr Reddys Labs Sa, and is included in twenty-six NDAs. There are three 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-eight suppliers are listed for this compound.

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
Nykøbing Falster County HospitalN/A
Steno Diabetes Center OdenseN/A
Hillerod Hospital, DenmarkN/A

See all ezetimibe clinical trials

Pharmacology for ezetimibe
Medical Subject Heading (MeSH) Categories for ezetimibe
Paragraph IV (Patent) Challenges for EZETIMIBE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZETIA Tablets ezetimibe 10 mg 021445 1 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
Teva Pharms Usa EZETIMIBE ezetimibe TABLET;ORAL 078724-001 Jun 12, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms EZETIMIBE ezetimibe TABLET;ORAL 204331-001 Jun 12, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms Co EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 208831-004 Nov 21, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 201890-004 Apr 26, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-003 Mar 23, 2021 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Aurobindo Pharma Usa EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 200082-003 Dec 17, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 208699-004 Jun 27, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ⤷  Sign Up ⤷  Sign Up
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ⤷  Sign Up ⤷  Sign Up
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ⤷  Sign Up ⤷  Sign Up
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ⤷  Sign Up ⤷  Sign Up
Organon ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ezetimibe

Country Patent Number Title Estimated Expiration
South Korea 100883461 ⤷  Sign Up
Mexico PA03005671 2-AZETIDINONAS SUSTITUIDAS CON AZUCARES UTILES COMO AGENTES HIPOCOLESTEROLEMICOS. (SUGAR-SUBSTITUTED 2-AZETIDINONES USEFUL AS HYPOCHOLESTEROLEMIC AGENTS.) ⤷  Sign Up
Norway 20033357 ⤷  Sign Up
Japan 2012087149 COMBINATIONS OF PEROXISOME PROLIFERATOR-ACTIVATED RECEPTOR (PPAR) ACTIVATORS AND STEROL ABSORPTION INHIBITORS AND TREATMENTS FOR VASCULAR INDICATIONS ⤷  Sign Up
New Zealand 545332 Combinations of sterol absorption inhibitor(s) with cardiovascular agent(s) for the treatment of vascular conditions ⤷  Sign Up
European Patent Office 1810693 ⤷  Sign Up
Turkey 200402758 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ezetimibe

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 2003/014 Ireland ⤷  Sign Up 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
0720599 CR 2014 00048 Denmark ⤷  Sign Up PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
0720599 03C0028 France ⤷  Sign Up PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
0720599 300689 Netherlands ⤷  Sign Up PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
0720599 CR 2014 00050 Denmark ⤷  Sign Up 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
0720599 SPC/GB03/023 United Kingdom ⤷  Sign Up 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 C300172 Netherlands ⤷  Sign Up PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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