Ezetimibe - Generic Drug Details
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What are the generic drug sources for ezetimibe and what is the scope of freedom to operate?
Ezetimibe
is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Ohm Labs Inc, Orient Pharma, Rising, Sandoz, Sciegen Pharms Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms, Organon, Althera Pharms, Ani Pharms, Aurobindo Pharma Usa, and Dr Reddys Labs Sa, and is included in twenty-five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Ezetimibe has two hundred and thirty-five patent family members in thirty-eight countries.
There are twenty-four drug master file entries for ezetimibe. Twenty-seven suppliers are listed for this compound.
Summary for ezetimibe
International Patents: | 235 |
US Patents: | 3 |
Tradenames: | 5 |
Applicants: | 20 |
NDAs: | 25 |
Drug Master File Entries: | 24 |
Finished Product Suppliers / Packagers: | 27 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 343 |
Patent Applications: | 6,424 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for ezetimibe |
Drug Sales Revenues: | Drug sales revenues for ezetimibe |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ezetimibe |
What excipients (inactive ingredients) are in ezetimibe? | ezetimibe excipients list |
DailyMed Link: | ezetimibe at DailyMed |
Recent Clinical Trials for ezetimibe
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
dotter | Phase 4 |
Novartis Pharmaceuticals | Phase 3 |
Organon and Co | Phase 4 |
Pharmacology for ezetimibe
Drug Class | Dietary Cholesterol Absorption Inhibitor |
Physiological Effect | Decreased Cholesterol Absorption |
Medical Subject Heading (MeSH) Categories for ezetimibe
Anatomical Therapeutic Chemical (ATC) Classes for ezetimibe
US Patents and Regulatory Information for ezetimibe
Expired US Patents for ezetimibe
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 |
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 ezetimibe
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4351842 | ⤷ Try a Trial | |
Austria | 362757 | ⤷ Try a Trial | |
Spain | 2287250 | ⤷ Try a Trial | |
Cyprus | 1106912 | ⤷ Try a Trial | |
European Patent Office | 1385548 | COMBINAISONS D'INHIBITEUR(S) DE L'ABSORPTION DE STEROLS ET D'AGENTS CARDIO-VASCULAIRES POUR LE TRAITEMENT D'AFFECTIONS VASCULAIRES (COMBINATIONS OF STEROL ABSORPTION INHIBITOR(S) WITH CARDIOVASCULAR AGENT(S) FOR THE TREATMENT OF VASCULAR CONDITIONS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ezetimibe
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0720599 | 03C0028 | France | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017 |
0720599 | C300688 | Netherlands | ⤷ Try a Trial | 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 | 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 | 92545 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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