Cilastatin sodium; imipenem; relebactam - Generic Drug Details

What are the generic drug sources for cilastatin sodium; imipenem; relebactam and what is the scope of freedom to operate?

Cilastatin sodium; imipenem; relebactam is the generic ingredient in one branded drug marketed by Msd Merck Co and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Cilastatin sodium; imipenem; relebactam has sixty-five patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for cilastatin sodium; imipenem; relebactam

International Patents:	65
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	cilastatin sodium; imipenem; relebactam at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cilastatin sodium; imipenem; relebactam

Dosage:

POWDER;INTRAVENOUS

^*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 cilastatin sodium; imipenem; relebactam

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Merck Sharp & Dohme Corp.	Phase 3

See all cilastatin sodium; imipenem; relebactam clinical trials

Pharmacology for cilastatin sodium; imipenem; relebactam

Drug Class	Penem Antibacterial Renal Dehydropeptidase Inhibitor
Mechanism of Action	Dipeptidase Inhibitors

US Patents and Regulatory Information for cilastatin sodium; imipenem; relebactam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes			Y	Y
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes

International Patents for cilastatin sodium; imipenem; relebactam

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2445314	ИНГИБИТОРЫ БЕТА-ЛАКТАМАЗ (BETA-LACTAMASE INHIBITORS)
Luxembourg	C00165
Japan	5038509
Spain	2533826
Netherlands	301051

Supplementary Protection Certificates for cilastatin sodium; imipenem; relebactam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2666774	CR 2020 00037	Denmark		PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
2666774	C202030035	Spain		PRODUCT NAME: RELEBACTAM, OPCIONALMENTE EN FORMA DE MONOHIDRATO E IMIPENEM Y CILASTATINA; NATIONAL AUTHORISATION NUMBER: EU/1/19/1420; DATE OF AUTHORISATION: 20200213; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1420; DATE OF FIRST AUTHORISATION IN EEA: 20200213
2231667	20C1030	France		PRODUCT NAME: RELEBACTAM OU UN MONOHYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/19/1420 20200217
2666774	301051	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
2666774	LUC00166	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, ET IMIPENEME; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217