zetia Drug Patent Profile
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Which patents cover Zetia, and when can generic versions of Zetia launch?
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.
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Questions you can ask:
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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 |
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 zetia
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 zetia
See the table below for patents covering zetia around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Luxembourg | 91050 | ⤷ Sign Up | |
Hong Kong | 1056695 | ⤷ Sign Up | |
Brazil | 0116212 | ⤷ Sign Up | |
Canada | 2434488 | ⤷ Sign Up | |
Czech Republic | 20031674 | ⤷ Sign Up | |
Japan | 4937836 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for zetia
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0720599 | 0390018-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: EZETIMIB |
0720599 | C300132 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION: RVG 28626 20030418; FIRST REGISTRATION: DE 54486.00.00, 54487.00.00, 54488.00.00, 54489.00.00 20021017 |
0720599 | 91160 | Luxembourg | ⤷ Sign Up | 91160, EXPIRES: 20190914 |
0720599 | 20/2003 | Austria | ⤷ Sign Up | 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 | SPC/GB05/010 | United Kingdom | ⤷ Sign Up | 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 | 05C0040 | France | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |