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MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER

NDA

MEROPENEM | N202106 | B BRAUN MEDICAL INC

2 strengths0 unique patents0 unique exclusivities

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Lachman Consulting Services, Inc. FDA-2026-P-8515 · 6 docket documents Lachman Consulting Services, Inc. filed a suitability petition requesting FDA determination that certain analytical methods are suitable for regulatory use in drug development and manufacturing. The petition asks the agency to evaluate whether specific testing procedures meet FDA standards for quali	Suitability	2026-07-31	Open	Lachman Consulting Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

101 trials from ClinicalTrials.gov — 5 recruiting, 1 active, 65 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Colistin and Meropenem Versus Amikacin and Meropenem for MDR Gram Negative Bacteria Regarding Efficacy and Safety.NCT07694700	Phase 4	Active	Beni-Suef University	100	2025-12-30 → 2026-09-30
Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria NCT07512596	Phase 2	Not Yet Recruiting	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	48	2026-07 → 2027-07
Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase Producing Enterobacterales Undergoing Liver Transplantation NCT07759453	Phase 3	Not Yet Recruiting	IRCCS Azienda Ospedaliero-Universitaria di Bologna	168	2026-10-01 → 2029-09-30
A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections NCT06828848	Phase 2	Recruiting	Menarini Group	44	2025-02-18 → 2026-07
PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)NCT03671967	Phase 4	Recruiting	Rambam Health Care Campus	1,084	2019-05-01 → 2027-04-01
The Vancomycin Piperacillin/Tazobactam (VPT) Patient Safety Trial (VPS)NCT07556107	Phase 4	Recruiting	Bassett Healthcare	852	2026-08-17 → 2028-12-31
PK/PD of Extended-infusion Meropenem, Piperacillin-tazobactam and Cefepime in the Early Phase of Septic Shock NCT02820987	Phase 3	Completed	Centre Hospitalier Universitaire de Besancon	119	2016-09-27 → 2018-10-04
Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)NCT01597973	Phase 3	Completed	University of Michigan	467	2012-10-06 → 2020-08-09
Meropenem Dosage Strategy Based on PPK Model NCT01944319	Phase 4	Completed	Qingtao Zhou	79	2013-07 → 2015-10
MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)NCT03217136	Phase 2	Completed	Merck Sharp & Dohme LLC	94	2018-04-03 → 2020-03-16

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain16 active DMFs16 inactive

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

SAVIOR LIFETEC CORPMeropenem USP

DMF 210612007

ACS DOBFAR SPAMEROPENEM FOR INJECTION

DMF 225032009

SUZHOU HOMESUN WANQING PHARMACEUTICAL CO LTDMEROPENEM FOR INJECTION STERILE BULK

DMF 232762009

SHENZHEN HAIBIN PHARMACEUTICAL CO LTDMEROPENEM STERILE

DMF 235242010

UNIMARK REMEDIES LTDMEROPENEM TECHNICAL

DMF 258692012

EUGIA PHARMA SPECIALITIES LTDMEROPENEM FOR INJECTION (STERILE BULK)

DMF 271922013

UNIMARK REMEDIES LTDMEROPENEM USP (STERILE)

DMF 282792014

SHANDONG ANHONG PHARMACEUTICAL CO LTDMEROPENEM WITH SODIUM CARBONATE

DMF 289752014

STERILE INDIA PVT LTDMEROPENEM FOR INJECTION USP

DMF 299852016

ACS DOBFAR SPAMEROPENEM TRIHYDRATE STERILE

DMF 304882016

ACS DOBFAR SPAMEROPENEM TRIHYDRATE NON STERILE

DMF 304892016

SHENZHEN HAIBIN PHARMACEUTICAL CO LTDMEROPENEM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE)

DMF 379272023

GLAND CHEMICALS PRIVATE LTDMEROPENEM FOR INJECTION STERILE BULK

DMF 401902025

RAJASTHAN ANTIBIOTICS LTDMEROPENEM FOR INJECTION USP [STERILE BLEND OF MEROPENEM USP (83%) AND SODIUM CARBONATE USP (17%)]

DMF 404432024

SHENZHEN HAIBIN PHARMACEUTICAL CO LTDMEROPENEM AND SODIUM CARBONATE (STERILE BULK)

DMF 414952025

SHENZHEN HAIBIN PHARMACEUTICAL CO LTDMEROPENEM INTERMEDIATE

DMF 415082025

SUMITOMO DAINIPPON PHARMA CO LTDInactiveMEROPENEM

DMF 103221993

SUMITOMO DAINIPPON PHARMA CO LTDInactiveMEROPENEM BULK BLEND

DMF 181022005

RANBAXY LABORATORIES LTDInactiveMeropenem Technical

DMF 211942007

PFIZER HEALTHCARE INDIA PVT LTDInactiveMEROPENEM + SODIUM CARBONATE (STERILE BULK)

DMF 217092008

PFIZER HEALTHCARE INDIA PVT LTDInactiveMEROPENEM (STERILE)

DMF 217102008

SAVIOR LIFETEC CORPInactiveMEROPENEM AND SODIUM CARBONATE (STERILE BULK)

DMF 218612008

PFIZER HEALTHCARE INDIA PVT LTDInactiveMEROPENEM (NON-STERILE)

DMF 221902008

RANBAXY LABORATORIES LTDInactiveMEROPENEM TECHNICAL

DMF 223532008

ZHUHAI UNITED LABORATORIES CO LTDInactiveMEROPENEM CRUDE NON-STERILE

DMF 238582010

KYONGBO PHARMACEUTICAL CO LTDInactiveMEROPENEM STERILE, BULK

DMF 257062011

ZHUHAI UNITED LABORATORIES CO LTDInactiveMEROPENEM FOR INJECTION BULK STERILE

DMF 258912012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveMEROPENEM STERILE

DMF 268202013

APITORIA PHARMA PRIVATE LTDInactiveMEROPENEM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE)

DMF 271682013

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveMEROPENEM, STERILE

DMF 276862013

SANDOZ PRIVATE LTDInactiveMEROPENEM TRIHYDRATE, STERILE

DMF 277852014

SANDOZ PRIVATE LTDInactiveMEROPENEM WITH SODIUM CARBONATE, STERILE BLEND

DMF 279222014

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Dec 4, 2024	SUPPL -9	View Letter (PDF)
May 13, 2020	SUPPL -7	View Letter (PDF)
May 13, 2020	SUPPL -7	View Letter (PDF)
Jan 26, 2018	SUPPL -3	View Letter (PDF)
May 5, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG/VIAL

RLD

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Apr 30, 2015

No patent or exclusivity listings for this strength.

#002 — 1GM/VIAL

RLD

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Apr 30, 2015