Ketamine hydrochloride - Generic Drug Details

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What are the generic sources for ketamine hydrochloride and what is the scope of freedom to operate?

Ketamine hydrochloride is the generic ingredient in two branded drugs marketed by Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, and Hospira, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for ketamine hydrochloride. Twelve suppliers are listed for this compound.

Sponsor	Phase
Brian Anderson, MD	Phase 4
Lindsay Maguire, MD	Phase 1
Washington University School of Medicine	Phase 2/Phase 3

Sponsor

Phase

Brian Anderson, MD

Phase 4

Lindsay Maguire, MD

Phase 1

Washington University School of Medicine

Phase 2/Phase 3

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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
Gland Pharma Ltd	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	216809-003	Jan 24, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	076092-001	Sep 30, 2008	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	074524-002	Mar 22, 1996	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	KETAMINE HYDROCHLORIDE	ketamine hydrochloride	INJECTABLE;INJECTION	216809-001	Jan 24, 2023	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

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	1,252
Patent Applications:	4,184
What excipients (inactive ingredients) are in ketamine hydrochloride?	ketamine hydrochloride excipients list
DailyMed Link:	ketamine hydrochloride at DailyMed

Drug Class	General Anesthetic
Physiological Effect	General Anesthesia