VYTORIN Drug Patent Profile
✉ Email this page to a colleague
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. Thirteen 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for VYTORIN?
- What are the global sales for VYTORIN?
- What is Average Wholesale Price for VYTORIN?
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: | 206 |
| 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-004 | Jul 23, 2004 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-002 | Jul 23, 2004 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-003 | Jul 23, 2004 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 VYTORIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-001 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-003 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-001 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-004 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-003 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | VYTORIN | ezetimibe; simvastatin | TABLET;ORAL | 021687-004 | Jul 23, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Taiwan | 200412944 | Pharmaceutical formulation | ⤷ Sign Up |
| Portugal | 1531805 | ⤷ Sign Up | |
| Argentina | 040588 | FORMULACION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE LA ABSORCION DEL COLESTEROL Y UN INHIBIDOR DE UNA HMG- CO A REDUCTASA | ⤷ Sign Up |
| Australia | 2009200768 | Composition comprising a cholesterol absorption inhibitor, an HMG-CoA reductase inhibitor and a stabilizing agent | ⤷ Sign Up |
| Ecuador | SP941119 | COMPUESTOS ANTIHIPERCOLESTEROLEMICOS | ⤷ Sign Up |
| Japan | S56122375 | NOVEL ANTIHYPERCHOLESTEREMIC COMPOUND* ITS INTERMEDIATE AND ITS MANUFACTURE | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VYTORIN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0720599 | 05C0040 | France | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402 |
| 0720599 | C00720599/02 | Switzerland | ⤷ Sign Up | FORMER OWNER: SCHERING CORPORATION, US |
| 0720599 | 03C0028 | France | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017 |
| 0720599 | SPC/GB05/010 | United Kingdom | ⤷ Sign Up | 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 | 300688 | Netherlands | ⤷ Sign Up | 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 | 20/2003 | Austria | ⤷ Sign Up | PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 1-24902 1-24904 20030415; FIRST REGISTRATION: DE 54486.00.00 - 54489.00.00 20021017 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
