Zetia Drug Patent Profile
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When do Zetia patents expire, 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-seven 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 |
>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 |
---|---|---|---|
Russian Federation | 2356550 | КОМБИНАЦИИ АКТИВАТОРА (АКТИВАТОРОВ) РЕЦЕПТОРА, АКТИВИРУЕМОГО ПРОЛИФЕРАТОРОМ ПЕРОКСИСОМ (РАПП), И ИНГИБИТОРА (ИНГИБИТОРОВ) ВСАСЫВАНИЯ СТЕРИНА И ЛЕЧЕНИЕ ЗАБОЛЕВАНИЙ СОСУДОВ (COMBINED ACTIVATOR (ACTIVATORS) OF RECEPTOR ACTIVATED WITH PEROXISE PROLIFERATOR (RAPP), AND STEROL ABSORPTION INHIBITOR (INHIBITORS) AND TREATMENT OF VESSEL DISEASES) | ⤷ Try a Trial |
Czech Republic | 301871 | Kombinace aktivátoru receptoru, aktivovaného proliferátorem peroxisomu fenofibrátu s inhibitorem vstrebávání sterolu ezetimibem pro použití pri cévních chorobách (Combinations of peroxisome proliferator-activated receptor activator phenofibrate with sterol absorption inhibitor ezetimibe for use in the treatment of vascular diseases) | ⤷ Try a Trial |
Canada | 2434504 | ⤷ Try a Trial | |
China | 1131416 | ⤷ 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 | SPC/GB05/010 | United Kingdom | ⤷ Try a 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 | 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 |
0720599 | 300132 | Netherlands | ⤷ Try a Trial | 300132, 20140914, EXPIRES: 20171016 |
0720599 | 92544 | Luxembourg | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |