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 |
Cairo University | N/A |
Aswan Heart Centre | 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 | 021687-003 | 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 |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-004 | 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 |
---|---|---|---|
Norway | 2017042 | ⤷ Try a Trial | |
Australia | 681445 | ⤷ Try a Trial | |
Philippines | 16584 | 6(R)-(2-(8-HYDROXY-2,6-DIMETHYL-POLYHYDRONAPHTHYL-1)-ETHYL-)-4(R)-HYDROXY-3,4,5,6-TETRAHYDRO-2H-PYRAN-2-ONES | ⤷ Try a Trial |
Slovenia | 1531805 | ⤷ 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 | 2003/014 | Ireland | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: 1091/1/1 00040127; FIRST REGISTRATION NO/DATE: EU: DE 54489.00.00 54486.00.00 54488.00.00 54487.00.00 20021017; PAEDIATRIC INVESTIGATION PLAN: P/0061/2012 |
0033538 | SPC/GB93/005 | United Kingdom | ⤷ Try a Trial | |
0720599 | SPC001/2005 | Ireland | ⤷ Try a Trial | SPC001/2005: 20050803, EXPIRES: 20190401 |
0720599 | CR 2014 00050 | Denmark | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |