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METFORMIN HYDROCHLORIDE

ANDA

METFORMIN HYDROCHLORIDE | A213356 | APOTEX INC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BAUSCH HEALTH IRELAND LIMITED v. APOTEX INC. 1:2019cv14474 2 patentsANDA 213356	D.N.J.	2019-06-28	Terminated 2019-09-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain34 active DMFs17 inactive

25 active API suppliers hold Drug Master Files for this ingredient.

MERCK SANTE SASMETFORMIN HYDROCHLORIDE

DMF 59511985

MERCK SANTE SASMETFORMIN HYDROCHLORIDE DRUG SUBTANCE

DMF 126701997

FARMHISPANIA SAMETFORMIN HYDROCHLORIDE

DMF 138691998

WANBURY LTDMETFORMIN HYDROCHLORIDE

DMF 140551999

SHANGHAI MEDICINAL LTDMETFORMIN HYDROCHLORIDE

DMF 147762000

OLON SPAMETFORMIN HYDROCHLORIDE

DMF 151482000

HARMAN FINOCHEM LTDMETFORMIN HYDROCHLORIDE

DMF 152172001

SUN PHARMACEUTICAL INDUSTRIES LTDMETFORMIN HYDROCHLORIDE USP

DMF 156122001

HOLIDAY LABS MEXICO SA DE CVMETFORMIN HYDROCHLORIDE

DMF 160472002

GRANULES INDIA LTDMETFORMIN HYDROCHLORIDE USP

DMF 166252003

APITORIA PHARMA PRIVATE LTDMETFORMIN HYDROCHLORIDE USP

DMF 169932003

USV PRIVATE LTDMETFORMIN HYDROCHLORIDE DC GRANULES

DMF 177432004

USV PRIVATE LTDMETFORMIN HYDROCHLORIDE USP (COARSE)

DMF 177442004

WANBURY LTDMETFORMIN HYDROCHLORIDE

DMF 181502005

WANBURY LTDMETFORMIN HYDROCHLORIDE DC GRADE - 90%

DMF 188872005

WANBURY LTDMETFORMIN HYDROCHLORIDE DC GRADE - 95%

DMF 188882005

VISTIN PHARMA ASMETFORMIN HYDROCHLORIDE

DMF 191902006

IPCA LABORATORIES LTDMETFORMIN HYDROCHLORIDE USP (PROCESS-II)

DMF 199252006

SOHAN HEALTHCARE PRIVATE LTDMETFORMIN HYDROCHLORIDE USP

DMF 216952008

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDMETFORMIN HYDROCHLORIDE

DMF 232732009

EXEMED PHARMACEUTICALSMETFORMIN HYDROCHLORIDE USP

DMF 254672011

KOTHARI PHYTOCHEMICALS INTERNATIONALMETFORMIN HYDROCHLORIDE USP

DMF 255642011

IOL CHEMICALS AND PHARMACEUTICALS LTDMETFORMIN HYDROCHLORIDE

DMF 271392013

LAURUS LABS LTDMETFORMIN HYDROCHLORIDE USP

DMF 301142016

MACLEODS PHARMACEUTICALS LTDMETFORMIN HYDROCHLORIDE

DMF 331982018

SHANDONG KEYUAN PHARMACEUTICAL CO LTDMETFORMIN HYDROCHLORIDE

DMF 338762019

IOL CHEMICALS AND PHARMACEUTICALS LTDMETFORMIN HYDROCHLORIDE USP (PROCESS II)

DMF 352652020

FARMHISPANIA SAMETFORMIN HYDROCHLORIDE + 0.5% MAGNESIUM STEARATE

DMF 374082022

NINGXIA HENGKANG TECHNOLOGY CO LTDMETFORMIN HYDROCHLORIDE USP

DMF 379592023

SHIJIAZHUANG CREADY PHARMACEUTICAL R AND D INCMETFORMIN HYDROCHLORIDE GRANULES

DMF 393042023

NINGXIA HENGKANG TECHNOLOGY CO LTDMETFORMIN HYDROCHLORIDE (2ND LINE)

DMF 396242024

MSN LIFE SCIENCES PRIVATE LTDMETFORMIN HYDROCHLORIDE USP

DMF 405162024

SHANDONG LURUI PHARMACEUTICAL CO LTDMETFORMIN HYDROCHLORIDE

DMF 410882024

SUN PHARMACEUTICAL INDUSTRIES LTDMETFORMIN HYDROCHLORIDE USP (LDMA PROCESS)

DMF 412212025

GROUPE LIPHAInactiveMETFORMIN HYDROCHLORIDE

DMF 119241996

TAPI PUERTO RICO INCInactiveMETFORMIN HYDROCHLORIDE DRUG SUBSTANCE

DMF 138271998

VIBRANTIS SA DE CVInactiveMETFORMIN HYDROCHLORIDE

DMF 151432000

KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTDInactiveMETFORMIN HYDROCHLORIDE

DMF 162722002

WOCKHARDT LTDInactiveMETFORMIN HYDROCHLORIDE

DMF 164742003

NOVUS FINE CHEMICALS LLCInactiveMETFORMIN HYDROCHLORIDE

DMF 168272003

IPCA LABORATORIES LTDInactiveMETFORMIN HYDROCHLORIDE USP

DMF 183232005

SMRUTHI ORGANICS LTDInactiveMETFORMIN HYDROCHLORIDE USP

DMF 183302005

IONS PHARMAInactiveMETFORMIN HYDROCHLORIDE USP

DMF 192282006

AURO LABORATORIES LTDInactiveMETFORMIN HYDROCHLORIDE

DMF 199102006

MS MARKSANS PHARMA LTDInactiveMETFORMIN HYDROCHLORIDE USP

DMF 199852006

INDOCO REMEDIES LTDInactiveMetformin Hydrochloride USP, as maufactured in Raigad District, INDIA

DMF 210972007

AARTI DRUGS LTDInactiveMETFORMIN HYDROCHLORIDE USP

DMF 212942008

HAINAN POLY PHARMACEUTICAL CO LTDInactiveMETFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS

DMF 237262010

SHANDONG KEYUAN PHARMACEUTICAL CO LTDInactiveMETFORMIN HYDROCHLORIDE

DMF 246042011

FARMHISPANIA SAInactiveMETFORMIN HYDROCHLORIDE / 0.75% COLLOIDAL SILICON DIOXIDE BLEND

DMF 268062012

LUPIN LTDInactiveMETFORMIN HYDROCHLORIDE USP

DMF 315102017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 500MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 13, 2021

No patent or exclusivity listings for this strength.

#002 — 1GM

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 13, 2021