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Last Updated: April 15, 2021

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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 freedom to operate?

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.

Drug Prices for simvastatin

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Drug Sales Revenue Trends for simvastatin

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Recent Clinical Trials for simvastatin

Identify potential brand extensions & 505(b)(2) entrants

Aswan Heart CentreN/A
Cairo UniversityN/A
Birmingham Heartlands HospitalPhase 2/Phase 3

See all simvastatin clinical trials

Generic filers with tentative approvals for SIMVASTATIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial80MGTABLET; ORAL
  Start Trial  Start Trial40MGTABLET; ORAL
  Start Trial  Start Trial20MGTABLET; 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
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
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-005 Sep 18, 2012 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Oxford Pharms SIMVASTATIN simvastatin TABLET;ORAL 078735-004 Aug 30, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma SIMVASTATIN simvastatin TABLET;ORAL 077691-003 Dec 20, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Biocon Limited SIMVASTATIN simvastatin TABLET;ORAL 078034-005 Dec 20, 2006 AB RX 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 019766-001 Dec 23, 1991   Start Trial   Start Trial
Msd Merck Co ZOCOR simvastatin TABLET;ORAL 019766-004 Dec 23, 1991   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

Supplementary Protection Certificates for simvastatin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 05C0040 France   Start Trial PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
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
0720599 C300172 Netherlands   Start Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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