VYTORIN Drug Patent Profile
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When do Vytorin patents expire, and what generic alternatives are available?
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 |
Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-003 | Jul 23, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
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 |
>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 |
---|---|---|---|
Ireland | 51478 | 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 |
Israel | 62044 | POLYHYDRONAPHTHYLETHYL TETRAHYDRO-2H-PYRAN-2-ONE DERIVATIVES AND HYDROXY ACIDS AND ESTERS THEREOF,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | ⤷ Try a Trial |
Japan | 2803908 | ⤷ Try a Trial | |
Bulgaria | 61418 | ⤷ Try a Trial | |
Ukraine | 82489 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ ВКЛЮЧАЕТ ИНГИБИТОР АБСОРБЦИИ ХОЛЕСТЕРИНА, ИНГИБИТОР HMG-CОA-РЕДУКТАЗЫ И СТАБИЛИЗИРУЮЩИЙ АГЕНТ, (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО ВКЛЮЧАЄ інгібітор абсорбції холестерину, інгібітор HMG-COA-редуктази ТА стабілізуючий агент, (ВАРІАНТИ) ТА СПОСІБ ЛІКУВАННЯ (COMPOSITION COMPRISING A CHOLESTEROL ABSORPTION INHIBITOR, AN HMG-COA REDUCTASE INHIBITOR AND A STABILIZING AGENT (VARIANTS), TREATMENT METHOD) | ⤷ Try a Trial |
Hungary | T73852 | ⤷ Try a Trial | |
Austria | 393628 | ⤷ 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 |
0720599 | 122004000026 | Germany | ⤷ Try a Trial | 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 | 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 |
0720599 | 300689 | Netherlands | ⤷ Try a Trial | 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 | 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 |
0720599 | 122014000088 | Germany | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |