Deeper Knowledge, Faster

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Julphar
Boehringer Ingelheim
Fish and Richardson
Federal Trade Commission
Fuji
Moodys
Healthtrust
Medtronic
McKesson
Chinese Patent Office

Generated: January 18, 2018

DrugPatentWatch Database Preview

Ezetimibe - Generic Drug Details

« Back to Dashboard

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

Ezetimibe
is the generic ingredient in four branded drugs marketed by Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Ohm Labs Inc, Sandoz Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms Usa Inc, Msd Intl Gmbh, Dr Reddys Labs Sa, Impax Labs Inc, and Msd Intl, and is included in fourteen NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ezetimibe has three hundred and six patent family members in forty-four countries.

There are twenty-four drug master file entries for ezetimibe. Twenty-two suppliers are listed for this compound. There are five tentative approvals for this compound.
Pharmacology for ezetimibe
Medical Subject Heading (MeSH) Categories for ezetimibe
Tentative approvals for EZETIMIBE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe10MGTABLET;ORAL
➤ Subscribe➤ Subscribe10MG; 80MGTABLET; ORAL
➤ Subscribe➤ Subscribe10MG; 40MGTABLET; ORAL

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
Msd Intl VYTORIN ezetimibe; simvastatin TABLET;ORAL 021687-001 Jul 23, 2004 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Watson Labs Inc EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 202968-003 Apr 26, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs Inc EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 202968-004 Apr 26, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Msd Intl Gmbh ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Impax Labs Inc EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 201890-002 Apr 26, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Sa EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 200909-001 Apr 26, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aurobindo Pharma Ltd EZETIMIBE ezetimibe TABLET;ORAL 209838-001 Aug 25, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Impax Labs Inc EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 201890-001 Apr 26, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Impax Labs Inc EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 201890-003 Apr 26, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Sa EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 200909-004 Apr 26, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for ezetimibe

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,056,906 Combinations of hormone replacement therapy composition(s) and sterol absorption inhibitor(s) and treatments for vascular conditions in post-menopausal women ➤ Subscribe
6,541,640 Process for the preparation of 4-haloalkylnicotinonitriles ➤ Subscribe
5,767,115 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents ➤ Subscribe
6,864,385 Process for the preparation of 4-haloalkylnicotinonitriles ➤ Subscribe
7,071,181 Methods and therapeutic combinations for the treatment of diabetes using sterol absorption inhibitors ➤ Subscribe
7,053,080 Methods and therapeutic combinations for the treatment of obesity using sterol absorption inhibitors ➤ Subscribe
6,982,251 Substituted 2-azetidinones useful as hypocholesterolemic agents ➤ Subscribe
5,631,365 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents ➤ Subscribe
5,846,966 Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors ➤ Subscribe
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for ezetimibe

Supplementary Protection Certificates for ezetimibe

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599/02 Switzerland ➤ Subscribe FORMER OWNER: SCHERING CORPORATION, US
544 Luxembourg ➤ Subscribe 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
/2005 Austria ➤ Subscribe PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
545 Luxembourg ➤ Subscribe PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
2014 00048 Denmark ➤ Subscribe 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
C0028 France ➤ Subscribe PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
2014 00050 Denmark ➤ Subscribe 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
C/GB03/023 United Kingdom ➤ Subscribe PRODUCT NAME: EZETIMIBE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: PL 19945/0001-0002 20021017; FIRST REGISTRATION: DE 54486.00.00, 54488.00.00, 54487.00.00, 54489.00.00 20021017
0132 Netherlands ➤ Subscribe 300132, 20140914, EXPIRES: 20171016
00172 Netherlands ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Federal Trade Commission
Cerilliant
Fuji
Healthtrust
Fish and Richardson
Dow
UBS
Covington

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.

botpot