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Healthtrust
Fuji
Moodys
Teva
UBS
QuintilesIMS
Baxter
Johnson and Johnson
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Generated: February 15, 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 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-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.

Pharmacology for metformin hydrochloride; sitagliptin phosphate
Tentative approvals for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up1GM; EQ 100MG BASETABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up1GM; EQ 50MG BASETABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up500MG; 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 Y ➤ Sign Up
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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
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 202270-003 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
Merck Sharp Dohme JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for metformin hydrochloride; sitagliptin phosphate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00037 Denmark ➤ Sign Up PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
00569 Netherlands ➤ Sign Up PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
6 4-2007 Slovakia ➤ Sign Up PRODUCT NAME: SITAGLIPTIN; NAT. REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 20070321; FIRST REGISTRATION: EU EU/1/07/383/001 - EU/1/07/383/018
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Moodys
Mallinckrodt
UBS
Merck
Medtronic
Cantor Fitzgerald
Citi
Daiichi Sankyo

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