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Last Updated: November 2, 2024

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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Drug patent expirations by year for ZETIA
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Pharmacology for ZETIA
Paragraph IV (Patent) Challenges for ZETIA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZETIA Tablets ezetimibe 10 mg 021445 1 2006-10-25

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

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