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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
Deloitte
Queensland Health
Fish and Richardson
Covington
Medtronic
Federal Trade Commission
McKesson

Generated: April 24, 2018

DrugPatentWatch Database Preview

Metformin hydrochloride; sitagliptin phosphate - Generic Drug Details

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

Metformin hydrochloride; sitagliptin phosphate
is the generic ingredient in two branded drugs marketed by Merck Sharp Dohme and is included in two NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; sitagliptin phosphate has one hundred and fifty patent family members in forty-five countries.

There are forty-eight drug master file entries for metformin hydrochloride; sitagliptin phosphate. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for metformin hydrochloride; sitagliptin phosphate
Pharmacology for metformin hydrochloride; sitagliptin phosphate
Tentative approvals for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up500MG; EQ 50MG BASETABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up1GM; EQ 100MG BASETABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up1GM; EQ 50MG BASETABLET, EXTENDED RELEASE;ORAL

US Patents and Regulatory Information for metformin hydrochloride; 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 JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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 metformin hydrochloride; sitagliptin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 ➤ Sign Up ➤ Sign Up
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for metformin hydrochloride; sitagliptin phosphate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,513,190 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
7,829,530 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
8,168,637 Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes ➤ Sign Up
8,318,669 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for metformin hydrochloride; sitagliptin phosphate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013 00001 Denmark ➤ Sign Up PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
07/029 Ireland ➤ Sign Up PRODUCT NAME: SITAGLIPTIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
0287 Netherlands ➤ Sign Up 300287, 20220705, EXPIRES: 20220320
2014000071 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Deloitte
Queensland Health
Medtronic
Federal Trade Commission
US Department of Justice
Fish and Richardson
Daiichi Sankyo

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