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 |
|---|---|---|---|
| Mexico | PA04002572 | METODOS PARA EL TRATAMIENTO O PREVENCION DE INFLAMACION VASCULAR USANDO INHIBIDORES DE ABSORCION DE ESTEROL. (METHODS FOR TREATING OR PREVENTING VASCULAR INFLAMMATION USING STEROL ABSORPTION INHIBITOR(S).) | ⤷ Sign Up |
| Austria | 348649 | ⤷ Sign Up | |
| Canada | 2434436 | ⤷ Sign Up | |
| Cyprus | 1108000 | ⤷ Sign Up | |
| European Patent Office | 1427409 | METHODES DE TRAITEMENT OU DE PREVENTION D'UNE INFLAMMATION VASCULAIRE AU MOYEN D'UN OU D'INHIBITEURS D'ABSORPTION DE STEROL (METHODS FOR TREATING OR PREVENTING VASCULAR INFLAMMATION USING STEROL ABSORPTION INHIBITOR(S)) | ⤷ Sign Up |
| Germany | 60129863 | ⤷ Sign Up | |
| Slovenia | 1353696 | ⤷ 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 | 300172 | Netherlands | ⤷ Sign Up | 300172, 20140914, EXPIRES: 20190401 |
| 0720599 | SZ 26/2005 | Austria | ⤷ Sign Up | |
| 0720599 | SPC014/2003 | Ireland | ⤷ Sign Up | SPC014/2003: 20050803, EXPIRES: 20171016 |
| 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 | 0390018-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: EZETIMIB |
| 0720599 | CR 2014 00050 | Denmark | ⤷ Sign Up | 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 |
| 0720599 | 03C0028 | France | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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.
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