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Last Updated: May 31, 2020

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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 patent protection?

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

Simvastatin; sitagliptin phosphate has one hundred and twenty-five patent family members in forty-six countries.

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

Summary for simvastatin; sitagliptin phosphate
Recent Litigation for simvastatin; sitagliptin phosphate

Identify potential future generic entrants

District Court Litigation
Case NameDate
In re: Sitagliptin Phosphate ('708 & '921) Patent Litigation2019-08-08
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.2019-05-02
Merck Sharp & Dohme Corp. v. Torrent Pharmaceuticals Limited2019-02-13

See all simvastatin; sitagliptin phosphate litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals, Inc.2019-10-30

See all simvastatin; sitagliptin phosphate litigation

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

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

Supplementary Protection Certificates for simvastatin; sitagliptin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 50/2008 Austria   Start Trial PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
1412357 PA2008013 Lithuania   Start Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1412357 DO 77; 5006-2008 Slovakia   Start Trial PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357 300287 Netherlands   Start 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 20070323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
AstraZeneca
Boehringer Ingelheim
Moodys
McKinsey

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