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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Chinese Patent Office
Covington
Daiichi Sankyo
Johnson and Johnson
Cerilliant
Deloitte
McKinsey
Merck

Generated: November 21, 2018

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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 simvastatin; sitagliptin phosphate 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 are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for simvastatin; sitagliptin phosphate.

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 202343-005 Sep 18, 2012 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-006 Sep 18, 2012 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-006 Sep 18, 2012 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for simvastatin; sitagliptin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-001 Oct 7, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-004 Sep 18, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-005 Sep 18, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for simvastatin; sitagliptin phosphate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00287 Netherlands ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
C0041 France ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
0080004 00019 Estonia ➤ Try a Free Trial PRODUCT NAME: JANUMET - SITAGLIPTIIN / METFORMIINVESINIKKLORIID
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Chinese Patent Office
Covington
Daiichi Sankyo
Johnson and Johnson
Cerilliant
Deloitte
McKinsey
Merck

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