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Simvastatin - Generic Drug Details
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What are the generic drug sources for simvastatin and what is the scope of patent protection?
Simvastatin
is the generic ingredient in four branded drugs marketed by Tcg Fluent Pharma, Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Limited, Dr Reddys Labs Inc, Hetero Labs Ltd Iii, Hisun Pharm Hangzhou, Ivax Sub Teva Pharms, Lupin, Micro Labs, Mylan Pharms Inc, Oxford Pharms, Sun Pharm Inds Ltd, Watson Labs Teva, Yaopharma Co Ltd, Zydus Pharms Usa, Msd Merck Co, and Merck Sharp Dohme, and is included in nineteen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Simvastatin has twelve patent family members in twelve countries.
There are forty drug master file entries for simvastatin. Thirty-eight suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for simvastatin
| International Patents: | 12 |
| US Patents: | 6 |
| Tradenames: | 4 |
| Applicants: | 19 |
| NDAs: | 19 |
| Drug Master File Entries: | 40 |
| Suppliers / Packagers: | 38 |
| Bulk Api Vendors: | 102 |
| Clinical Trials: | 507 |
| Patent Applications: | 7,372 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for simvastatin |
| Drug Sales Revenues: | Drug sales revenues for simvastatin |
| What excipients (inactive ingredients) are in simvastatin? | simvastatin excipients list |
| DailyMed Link: | simvastatin at DailyMed |
Recent Clinical Trials for simvastatin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cairo University | N/A |
| Aswan Heart Centre | N/A |
| Cures Within Reach, USA | Phase 2/Phase 3 |
Generic filers with tentative approvals for SIMVASTATIN
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 80MG | TABLET; ORAL |
| Start Trial | Start Trial | 40MG | TABLET; ORAL |
| Start Trial | Start Trial | 20MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for simvastatin
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for simvastatin
Paragraph IV (Patent) Challenges for SIMVASTATIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ZOCOR | TABLET;ORAL | simvastatin | 019766 |
US Patents and Regulatory Information for simvastatin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Pharms Inc | SIMVASTATIN | simvastatin | TABLET;ORAL | 090868-002 | Jun 8, 2010 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Dr Reddys Labs Inc | SIMVASTATIN | simvastatin | TABLET;ORAL | 077752-005 | Jan 23, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Pharms Inc | SIMVASTATIN | simvastatin | TABLET;ORAL | 090868-004 | Jun 8, 2010 | DISCN | No | No | Start Trial | Start Trial | Start 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 simvastatin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Msd Merck Co | ZOCOR | simvastatin | TABLET;ORAL | 019766-005 | Jul 10, 1998 | Start Trial | Start Trial |
| Msd Merck Co | ZOCOR | simvastatin | TABLET;ORAL | 019766-003 | Dec 23, 1991 | Start Trial | Start Trial |
| Msd Merck Co | ZOCOR | simvastatin | TABLET;ORAL | 019766-001 | Dec 23, 1991 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for simvastatin
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 2018153 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007125339 | Start Trial |
| Spain | 2385752 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for simvastatin
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0720599 | 26/2005 | Austria | Start Trial | PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402 |
| 0720599 | SPC/GB05/010 | United Kingdom | Start 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 | 122004000026 | Germany | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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