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-eight 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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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 |
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 |
---|---|---|---|
Cyprus | 1107174 | ⤷ Sign Up | |
Germany | 60106489 | ⤷ Sign Up | |
Germany | 60224163 | ⤷ Sign Up | |
China | 1658903 | ⤷ Sign Up | |
New Zealand | 542090 | Combinations of sterol absorption inhibitor(s) with blood modifier(s) for treating vascular conditions | ⤷ Sign Up |
Ecuador | SP034703 | COMBINACIONES DE INHIBIDOR(ES) DE ABSORCION DE ESTEROL CON AGENTE(S) CARDIOVASCULAR(ES) PARA EL TRATAMINTO DE CONDICIONES VASCULARES | ⤷ Sign Up |
Slovenia | 1353694 | ⤷ 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 | C300688 | Netherlands | ⤷ Sign Up | 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 | 26/2005 | Austria | ⤷ Sign Up | 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 |
0720599 | 122014000088 | Germany | ⤷ Sign Up | PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912 |
0720599 | SZ 26/2005 | Austria | ⤷ Sign Up | |
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 | 122004000026 | Germany | ⤷ Sign Up | PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402 |
0720599 | SPC001/2005 | Ireland | ⤷ Sign Up | SPC001/2005: 20050803, EXPIRES: 20190401 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |