Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 21, 2019

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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 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-three patent family members in forty-five countries.

There are forty-nine drug master file entries for metformin hydrochloride; sitagliptin phosphate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for metformin hydrochloride; sitagliptin phosphate

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SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Merck Sharp & Dohme Corp.N/A
University of NebraskaN/A

See all metformin hydrochloride; sitagliptin phosphate clinical trials

Recent Litigation for metformin hydrochloride; sitagliptin phosphate

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District Court Litigation
Case NameDate
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.2019-05-02
Merck Sharp & Dohme Corp. v. Sandoz Inc.2019-02-13
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.2019-02-13

See all metformin hydrochloride; sitagliptin phosphate litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals, Inc.2019-10-30
Endo Pharmaceutical Inc.2014-04-17
Purdue Pharma L.P.2014-01-24

See all metformin hydrochloride; sitagliptin phosphate litigation

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1GM; EQ 100MG BASETABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial1GM; EQ 50MG BASETABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial500MG; EQ 50MG BASETABLET, EXTENDED RELEASE;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 metformin hydrochloride; sitagliptin phosphate
Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Tradename Dosage Ingredient NDA Submissiondate
JANUMET XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; sitagliptin phosphate 202270 2012-10-22
JANUMET XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; sitagliptin phosphate 202270 2012-03-16
JANUMET TABLET;ORAL metformin hydrochloride; sitagliptin phosphate 022044 2010-10-18

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   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes 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 metformin hydrochloride; sitagliptin phosphate

Supplementary Protection Certificates for metformin hydrochloride; sitagliptin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 2007/029 Ireland   Start Trial PRODUCT NAME: SITAGLIPTIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
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
1532149 CA 2013 00001 Denmark   Start Trial 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
1506211 122014000070 Germany   Start Trial 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
1506211 C 2014 029 Romania   Start Trial PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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