Cilastatin sodium; imipenem - Generic Drug Details

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

Cilastatin sodium; imipenem is the generic ingredient in three branded drugs marketed by Merck, Acs Dobfar, Hospira Inc, Hq Spclt Pharma, and Msd Merck Co, and is included in eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for cilastatin sodium; imipenem

US Patents:	1
Tradenames:	3
Applicants:	5
NDAs:	8
Finished Product Suppliers / Packagers:	3
Clinical Trials:	2
DailyMed Link:	cilastatin sodium; imipenem at DailyMed

Recent Clinical Trials for cilastatin sodium; imipenem

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 clinical trials

Pharmacology for cilastatin sodium; imipenem

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

US Patents and Regulatory Information for cilastatin sodium; imipenem

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira Inc	IMIPENEM AND CILASTATIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	090825-001	Nov 16, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819-001	Jul 16, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-001	Dec 14, 1990		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira Inc	IMIPENEM AND CILASTATIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	091007-001	Nov 16, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acs Dobfar	IMIPENEM AND CILASTATIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	090577-001	Dec 21, 2011		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hq Spclt Pharma	IMIPENEM AND CILASTATIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	207594-001	Dec 12, 2019	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for cilastatin sodium; imipenem

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587-002	Nov 26, 1985	⤷ Sign Up	⤷ Sign Up
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-001	Dec 14, 1990	⤷ Sign Up	⤷ Sign Up
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587-001	Nov 26, 1985	⤷ Sign Up	⤷ Sign Up
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAMUSCULAR	050630-002	Dec 14, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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