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MERREM IV

NDA

MEROPENEM | N050706 | PFIZER 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

42 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 32 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis NCT06672978	Phase 2	Active	Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)	66	2025-06-03 → 2027-07
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 → 2027-10
Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens NCT06342115	Phase 4	Recruiting	Beneficência Portuguesa de São Paulo	55	2025-03-26 → 2027-12
Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections NCT02687906	Phase 1	Completed	Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)	39	2016-07 → 2026-07-15
A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia NCT06841731	Phase 2	Completed	Jiangsu HengRui Medicine Co., Ltd.	120	2025-04-10 → 2026-10-09
Meropenem Penetration Across BBB in Patients With CNS Infection and Optimization of Meropenem Treatment NCT02506686	Phase 4	Completed	Huashan Hospital	82	2008-09 → 2009-12
Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients NCT03344627	N/A	Completed	Mahidol University	76	2017-11-27 → 2018-12-31
A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants NCT03182504	Phase 1	Completed	Hoffmann-La Roche	21	2017-06-15 → 2017-08-10
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia NCT01808092	Phase 3	Completed	Pfizer	969	2013-04 → 2016-01
Bacterial Load Guided Therapy for Severe Bronchiectasis Exacerbations NCT02047773	Phase 4	Completed	University of Edinburgh	90	2014-01 → 2020-02-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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

18 letters from Drugs@FDA

Date	Submission	Document
May 6, 2025	SUPPL -45	View Letter (PDF)
Dec 4, 2024	SUPPL -44	View Letter (PDF)
Apr 30, 2019	SUPPL -41	View Letter (PDF)
Jun 5, 2018	SUPPL -40	View Letter (PDF)
Jan 26, 2018	SUPPL -39	View Letter (PDF)
Jan 5, 2017	SUPPL -37	View Letter (PDF)
Jul 28, 2016	SUPPL -36	View Letter (PDF)
Dec 24, 2014	SUPPL -35	View Letter (PDF)
Dec 17, 2013	SUPPL -34	View Letter (PDF)
Dec 17, 2013	SUPPL -32	View Letter (PDF)
Apr 1, 2013	SUPPL -31	View Letter (PDF)
Dec 28, 2010	SUPPL -28	View Letter (PDF)
Nov 20, 2009	SUPPL -25	View Letter (PDF)
Apr 2, 2008	SUPPL -22	View Letter (PDF)
Mar 17, 2008	SUPPL -23	View Letter (PDF)
Aug 19, 2005	SUPPL -20	View Letter (PDF)
May 26, 2005	SUPPL -18	View Letter (PDF)
Jun 7, 2004	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1GM/VIAL

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 21, 1996

No patent or exclusivity listings for this strength.

#003 — 500MG/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 21, 1996