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Last Updated: March 19, 2024

Simvastatin; sitagliptin phosphate - Generic Drug Details


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What are the generic drug sources for simvastatin; sitagliptin phosphate and what is the scope of freedom to operate?

Simvastatin; sitagliptin phosphate is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Simvastatin; sitagliptin phosphate has fifty-two patent family members in forty countries.

Summary for simvastatin; sitagliptin phosphate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for simvastatin; sitagliptin phosphate
Generic Entry Date for simvastatin; sitagliptin phosphate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for simvastatin; sitagliptin phosphate

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 202343-001 Oct 7, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-004 Sep 18, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-006 Sep 18, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-002 Oct 7, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-005 Sep 18, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 simvastatin; sitagliptin phosphate

International Patents for simvastatin; sitagliptin phosphate

Country Patent Number Title Estimated Expiration
Taiwan I347185 ⤷  Try a Trial
South Korea 101013431 ⤷  Try a Trial
Spain 2291907 ⤷  Try a Trial
Malaysia 139595 PHOSPHORIC ACID SALT OF A DIPEPTIDYL - IV INHIBITOR ⤷  Try a Trial
Canada 2529400 SEL D'ACIDE PHOSPHORIQUE D'UN INHIBITEUR DE LA DIPEPTIDYL PEPTIDASE IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for simvastatin; sitagliptin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 26/2005 Austria ⤷  Try a 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 ⤷  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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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