Cilastatin sodium; imipenem; relebactam - Generic Drug Details

What are the generic drug sources for cilastatin sodium; imipenem; relebactam and what is the scope of patent protection?

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
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

International Patents for cilastatin sodium; imipenem; relebactam

Country	Patent Number	Title	Estimated Expiration
Croatia	P20150269
Israel	206395	N-הטרוציקליל-7-אוקסו-6-סולפאוקסי-6,1-דיאזאביציקלו[1.2.3]אוקטן-2-קרבוקסאמידים ותכשירים רוקחיים המכילים אותם (N-heterocyclyl-7-oxo-6-sulfooxy-1,6-diazabicyclo[3.2.1]octane-2-carboxamides and pharmaceutical compositions comprising them)
Japan	5597164
Colombia	6331438	INHIBIDORES DE BETA-LACTAMASA
Costa Rica	11626	INHIBIDORES DE BETA-LACTAMASA

Supplementary Protection Certificates for cilastatin sodium; imipenem; relebactam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2666774	PA2020517,C2666774-1	Lithuania		PRODUCT NAME: RELEBAKTAMAS, PASIRINKTINAI MONOHIDRATO PAVIDALU, IR IMIPENEMAS; REGISTRATION NO/DATE: EU/1/19/1420 20200213
2666774	20C1032	France		PRODUCT NAME: RELEBACTAM OPTIONNELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE OPTIONNELLEMENT SOUS FORME DE SEL SODIQUE; REGISTRATION NO/DATE: EU/1/19/1420 20200217
2231667	2020023	Norway		PRODUCT NAME: RELEBACTAM ELLER ET MONOHYDRAT DERAV; REG. NO/DATE: EU/1/19/1420 20200220
2666774	LUC00167	Luxembourg		PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
2666774	122020000035	Germany		PRODUCT NAME: RELEBACTAM, ODER RELEBACTAM IN FORM DES MONOHYDRATES, UND IMIPENEM; REGISTRATION NO/DATE: EU/1/19/1420 20200213