NEOSTIGMINE METHYLSULFATE - Generic Drug Details

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What are the generic drug sources for neostigmine methylsulfate and what is the scope of freedom to operate?

Neostigmine methylsulfate is the generic ingredient in three branded drugs marketed by Exela Pharma, Adaptis, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Be Pharms, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Sagent Pharms Inc, Umedica, and Avet Lifesciences, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for neostigmine methylsulfate. Twenty-five suppliers are listed for this compound.

Sponsor	Phase
Seoul National University Hospital	N/A
Alexandria University	Phase 4
Kasr El Aini Hospital	Phase 4

Sponsor

Phase

Seoul National University Hospital

N/A

Alexandria University

Phase 4

Kasr El Aini Hospital

Phase 4

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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
Caplin	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	213074-002	Apr 20, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	209182-001	May 4, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	203629-001	Jan 8, 2015		RX	Yes	Yes	⤷ 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:	3
Applicants:	18
NDAs:	20
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	9
Patent Applications:	2,155
Drug Prices:	Drug price trends for NEOSTIGMINE METHYLSULFATE
What excipients (inactive ingredients) are in NEOSTIGMINE METHYLSULFATE?	NEOSTIGMINE METHYLSULFATE excipients list
DailyMed Link:	NEOSTIGMINE METHYLSULFATE at DailyMed

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors