ZETIA Drug Patent Profile
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Which patents cover Zetia, and what generic alternatives are available?
Zetia is a drug marketed by Organon and is included in one NDA. There is one patent 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-six suppliers are listed for this compound. Additional details are available on the ezetimibe profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zetia
A generic version of ZETIA was approved as ezetimibe by GLENMARK PHARMS LTD on June 26th, 2015.
Summary for ZETIA
International Patents: | 235 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Patent Applications: | 4,136 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ZETIA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZETIA |
What excipients (inactive ingredients) are in ZETIA? | ZETIA excipients list |
DailyMed Link: | ZETIA at DailyMed |
Pharmacology for ZETIA
Drug Class | Dietary Cholesterol Absorption Inhibitor |
Physiological Effect | Decreased Cholesterol Absorption |
Anatomical Therapeutic Chemical (ATC) Classes for ZETIA
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Organon | ZETIA | ezetimibe | TABLET;ORAL | 021445-001 | Oct 25, 2002 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Organon | ZETIA | ezetimibe | TABLET;ORAL | 021445-001 | Oct 25, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | ZETIA | ezetimibe | TABLET;ORAL | 021445-001 | Oct 25, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | ZETIA | ezetimibe | TABLET;ORAL | 021445-001 | Oct 25, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | ZETIA | ezetimibe | TABLET;ORAL | 021445-001 | Oct 25, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | ZETIA | ezetimibe | TABLET;ORAL | 021445-001 | Oct 25, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZETIA
See the table below for patents covering ZETIA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2009132745 | SUGAR-SUBSTITUTED 2-AZETIDINONE USEFUL AS HYPOCHOLESTEROLEMIC AGENT | ⤷ Try a Trial |
Slovakia | 286703 | ⤷ Try a Trial | |
Japan | 4777602 | ⤷ Try a Trial | |
New Zealand | 274041 | SUBSTITUTED 1,4-DIARYL-3-ARALKYL-AZETIDIN-2-ONE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS | ⤷ Try a Trial |
Cyprus | 1106915 | ⤷ Try a Trial | |
Hungary | T73852 | ⤷ Try a Trial | |
Japan | 2004516299 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZETIA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0720599 | 20/2003 | Austria | ⤷ Try a 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 | 300132 | Netherlands | ⤷ Try a Trial | 300132, 20140914, EXPIRES: 20171016 |
0720599 | 91160 | Luxembourg | ⤷ Try a Trial | 91160, EXPIRES: 20190914 |
0720599 | CR 2014 00048 | Denmark | ⤷ Try a Trial | 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 | C300688 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724 |
0720599 | C00720599/02 | Switzerland | ⤷ Try a Trial | FORMER OWNER: SCHERING CORPORATION, US |
0720599 | 300688 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NATIONAL REGISTRATION NO/DATE: RVG114002-004 20140811; FIRST REGISTRATION: NO 13-9663 - 9665 20140724 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |