VYTORIN Drug Patent Profile
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Which patents cover Vytorin, and when can generic versions of Vytorin launch?
Vytorin is a drug marketed by Organon and is included in one NDA.
The generic ingredient in VYTORIN is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Vytorin
A generic version of VYTORIN was approved as ezetimibe; simvastatin by DR REDDYS LABS SA on April 26th, 2017.
Summary for VYTORIN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 41 |
Patent Applications: | 234 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for VYTORIN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VYTORIN |
What excipients (inactive ingredients) are in VYTORIN? | VYTORIN excipients list |
DailyMed Link: | VYTORIN at DailyMed |
Recent Clinical Trials for VYTORIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Samsung Medical Center | Phase 4 |
Aswan Heart Centre | N/A |
Cairo University | N/A |
Pharmacology for VYTORIN
Drug Class | Dietary Cholesterol Absorption Inhibitor HMG-CoA Reductase Inhibitor |
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Physiological Effect | Decreased Cholesterol Absorption |
Anatomical Therapeutic Chemical (ATC) Classes for VYTORIN
Paragraph IV (Patent) Challenges for VYTORIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VYTORIN | Tablets | ezetimibe; simvastatin | 10 mg/10 mg 10 mg/20 mg 10 mg/40 mg 10 mg/80 mg | 021687 | 1 | 2009-07-27 |
US Patents and Regulatory Information for VYTORIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-001 | Jul 23, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-004 | Jul 23, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-002 | Jul 23, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-003 | Jul 23, 2004 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 VYTORIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-001 | Jul 23, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-001 | Jul 23, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-002 | Jul 23, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-001 | Jul 23, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VYTORIN
See the table below for patents covering VYTORIN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2005538104 | ⤷ Try a Trial | |
Cyprus | 1404 | 6(R)-(2-(8'-ACYLOXY-2'-METHYL-6'-METHYL (OR HYDROGEN)-POLYHYDRONAPHTHYL-1')-ETHYL)-4(R)-HYDROXY-3,4,5,6-TETRAHYDRO-2H-PYRAN-2-ONES, THE HYDROXY ACID FORM OF SAID PYRANONES, THE PHARMACEUTICALLY ACCEPTABLE SALTS OF SAID HYDROXY ACIDS, AND THE LOWER ALKYL, AND PHENYL, DIMETHYLAMINO OR ACETYLAMINO SUBSTITUTED LOWER ALKYL ESTERS OF SAID HYDROXY ACID, PROCESSES FOR PREPARING THE SAME, AND A PHARMACEUTICAL ANTIHYPERCHOLESTEROLEMIC COMPOSITION CONTAINING THE SAME | ⤷ Try a Trial |
Latvia | 5249 | Piranonu iegusanas metode | ⤷ Try a Trial |
Ecuador | SP055573 | COMPOSICIÓN QUE COMPRENDE UN INHIBIDOR DE LA ABSORCIÓN DEL COLESTEROL, UN INHIBIDOR DE HMG-CoA REDUCTASA Y UN AGENTE ESTABILIZANTE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VYTORIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0720599 | CA 2005 00003 | Denmark | ⤷ Try a Trial | |
0720599 | 10399001 | Germany | ⤷ Try a Trial | PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ HIERVON; REGISTRATION NO/DATE: 54486.00.00 20021017 |
0033538 | SPC/GB93/005 | United Kingdom | ⤷ Try a Trial | |
0720599 | CR 2014 00048 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |