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AMOXICILLIN | N050813 | PRAGMA PHARMACEUTICALS LLC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expiring < 1yr (3)Today

2027

Today

8299052

May. 7, 2027

8357394

Dec. 8, 2026

8778924

Dec. 8, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain16 active DMFs34 inactive

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

TEVA PHARMACEUTICAL INDUSTRIES LTDAMOXICILLIN TRIHYDRATE USP

DMF 135181998

ANTIBIOTICOS SAAMOXICILLIN

DMF 135491998

CENTRIENT PHARMACEUTICALS NETHERLANDS BVAMOXICILLIN TRIHYDRATE (PURIMOX®)

DMF 169502003

SANDOZ INDUSTRIAL PRODUCTS SAAMOXICILLIN SODIUM (NON-STERILE BULK)

DMF 180442005

APITORIA PHARMA PRIVATE LTDAMOXICILLIN USP

DMF 188162005

CENTRIENT PHARMACEUTICALS NETHERLANDS BVAMOXICILLIN TRIHYDRATE (PURIMOX)

DMF 258752012

ANTIBIOTICOS DE LEON SLUAMOXICILLIN TRIHYDRATE

DMF 307252016

APITORIA PHARMA PRIVATE LTDAMOXICILLIN USP (ENZYME ROUTE)

DMF 313042017

FERSINSA GB SA DE CVAMOXICILLIN TRIHYDRATE - PURIMOX®

DMF 321572017

SINOPHARM WEIQIDA PHARMACEUTICAL CO LTDAMOXICILLIN TRIHYDRATE, USP

DMF 328112018

SINOPHARM WEIQIDA PHARMACEUTICAL CO LTDAMOXICILLIN TRIHYDRATE (POWDER)

DMF 365792021

SINOPHARM WEIQIDA PHARMACEUTICAL CO LTDAMOXICILLIN TRIHYDRATE (COMPACTED POWDER)

DMF 366982022

INNER MONGOLIA CHANGSHENG PHARMACEUTICAL CO LTDAMOXICILLIN TRIHYDRATE

DMF 379242023

SANDOZ GMBHAMOXICILLIN TRIHYDRATE

DMF 380862023

FRESENIUS KABI IPSUM SRLAMOXICILLIN SODIUM STERILE

DMF 383492023

APITORIA PHARMA PRIVATE LTDAMOXICILLIN SODIUM (NON-STERILE)

DMF 391982023

CONSOLIDATED PHARMACEUTICAL GROUP INCInactiveAMOXICILLIN TRIHYDRATE BPC

DMF 114511995

CONSOLIDATED PHARMACEUTICAL GROUP INCInactiveAMOXICILLIN TRIHYDRATE CAPSULES

DMF 114811995

CONSOLIDATED PHARMACEUTICAL GROUP INCInactiveAMOXICILLIN TRIHYDRATE FOR ORAL SUSPENSION

DMF 114831995

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveAMOXICILLIN USP, TRIHYDRATE, (NON-STERILE BULK)

DMF 128951998

SMITHKLINE BEECHAMInactiveAMOXICILLIN TRIHYDRATE

DMF 132011998

GLAXOSMITHKLINE LLCInactiveAMOXICILLIN TRIHYDRATE

DMF 132071998

SINTESIS QUIMICAInactiveAMOXICILLIN TRIHYDRATE

DMF 132151998

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveAMOXICILLIN TRIHYDRATE

DMF 134811998

CORDEN PHARMA LATINA SPAInactiveAMOXICILLIN

DMF 134981998

BARCELONETA INC DIV BRISTOL MYERSInactiveAMOXICILLIN TRIHYDRATE

DMF 135251998

CANADA PACKERS INC FINE CHEMICALS DIVInactiveAMOXICILLIN TRIHYDRATE

DMF 135511998

PIERREL AMERICA INCInactiveAMOXICILLIN TRIHYDRATE

DMF 135521998

ANKERMAN SPAInactiveAMOXICILLIN TRIHYDRATE

DMF 135561998

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveAMOXICILLIN TRIHYDRATE

DMF 135601998

COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARLInactiveAMOXICILLIN TRIHYDRATE

DMF 135861998

ISFInactiveAMOXICILLIN TRIHYDRATE

DMF 135871998

TRADEInactiveAMOXICILLIN

DMF 135931998

LARKInactiveAMOXICILLIN

DMF 135961998

FERMENTA PRODUCTS INCInactiveAMOXICILLIN

DMF 136161998

CONSOLIDATED PHARMACEUTICAL GROUP INCInactiveAMOXICILLIN

DMF 136241998

PRO CHIM RE SPAInactiveAMOXICILLIN TRIHYDRATE

DMF 136771998

CEPAInactiveAMOXICILLIN

DMF 136991998

GIST-BROCADES NV PHARMACEUTICALSInactiveAMOXICILLIN

DMF 137311998

DAEWOONG BIO INCInactiveAMOXICILLIN

DMF 137721998

FERSINSA GB SA DE CVInactiveAMOXICILLIN TRIHYDRATE

DMF 137761998

KDL BIOTECH LTDInactiveAMOXICILLIN TRIHYDRATE

DMF 137781998

ZHUHAI UNITED LABORATORIES CO LTDInactiveAMOXICILLIN USP BULK SUBSTANCE

DMF 153772001

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTDInactiveAMOXICILLIN

DMF 173242004

TEVA PHARMACEUTICALS USA INCInactiveAMOXICILLIN SODIUM

DMF 182592005

AUROBINDO PHARMA LTDInactiveAMOXICILLIN SODIUM (STERILE) BULK

DMF 201282006

ZHUHAI UNITED LABORATORIES CO LTDInactiveAMOXICILLIN TRIHYDRATE USP

DMF 205172007

ZHUHAI UNITED LABORATORIES CO LTDInactiveAMOXICILLIN (COMPACTED)

DMF 211972008

GLAXOSMITHKLINE LLCInactiveAMOXICILLIN SODIUM

DMF 244712011

NORTH CHINA PHARMACEUTICAL GROUP SEMISYNTECH CO LTDInactiveAMOXICILLIN TRIHYDRATE (NON STERILE, API)

DMF 260662012

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
May 2, 2024	SUPPL -10	View Letter (PDF)
May 18, 2022	SUPPL -9	View Letter (PDF)
Nov 12, 2019	SUPPL -8	View Letter (PDF)
Jun 10, 2015	SUPPL -3	View Letter (PDF)
Jan 25, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 775MG

RLD

3 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 23, 2008

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8299052	May 7, 2027	—	—	—		—
8357394	Dec 8, 2026	—	—	Yes	—	—
8778924	Dec 8, 2026	—	Yes	Yes		—