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Last Updated: November 2, 2024

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - Generic Drug Details


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What are the generic 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 Msd Sub Merck and is included in two NDAs. There are two 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 sixty-one patent family members in forty countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
Generic Entry Dates for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL
Generic Entry Dates for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Galenicum HealthPhase 1
The Affiliated Hospital of Qingdao UniversityPhase 1
First Affiliated Hospital Xi'an Jiaotong UniversityN/A

See all METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE clinical trials

Generic filers with 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

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 Strength NDA ANDAs Submitted Submissiondate
JANUMET XR Extended-release Tablets metformin hydrochloride; sitagliptin phosphate 100 mg/1000 mg 202270 1 2012-10-22
JANUMET XR Extended-release Tablets metformin hydrochloride; sitagliptin phosphate 50 mg/500 mg and 50 mg/1000 mg 202270 1 2012-03-16
JANUMET Tablets metformin hydrochloride; sitagliptin phosphate 50 mg/500 mg and 50 mg/1000 mg 022044 5 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
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-001 Mar 30, 2007 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Msd Sub Merck JANUMET metformin hydrochloride; sitagliptin phosphate TABLET;ORAL 022044-002 Mar 30, 2007 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

International Patents for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Country Patent Number Title Estimated Expiration
Costa Rica 8117 SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV ⤷  Sign Up
Germany 602004008938 ⤷  Sign Up
Jordan 2625 املاح حمض الفسفوريك لمثبط ثنائي الببتيديل بيتيديز 4 (Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor) ⤷  Sign Up
Eurasian Patent Organization 200600095 СОЛЬ ФОСФОРНОЙ КИСЛОТЫ ИНГИБИТОРА ДИПЕПТИДИЛПЕПТИДАЗЫ-IV ⤷  Sign Up
South Korea 101013431 ⤷  Sign Up
Norway 20060362 ⤷  Sign Up
Ukraine 86026 СОЛЬ ФОСФОРНОЙ КИСЛОТЫ ИНГИБИТОРА ДИПЕПТИДИЛПЕПТИДАЗЫ-IV;СІЛЬ ФОСФОРНОЇ КИСЛОТИ ІНГІБІТОРА ДИПЕПТИДИЛПЕПТИДАЗИ-IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 PA2014026 Lithuania ⤷  Sign Up PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211 CA 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
1506211 42/2014 Austria ⤷  Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
1506211 132014902277722 Italy ⤷  Sign Up PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
1261586 15/2012 Austria ⤷  Sign Up PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
2498758 301040 Netherlands ⤷  Sign Up PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113
2498758 PA2020003,C2498758 Lithuania ⤷  Sign Up PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.