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, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Be Pharms, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Indoco, Meitheal, Nivagen Pharms Inc, Par Sterile Products, Sagent Pharms Inc, 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-six suppliers are listed for this compound.

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

Sponsor

Phase

Seoul National University Hospital

N/A

Kasr El Aini Hospital

Phase 4

Alexandria University

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
Amphastar Pharms Inc	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	209933-001	Sep 25, 2017	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Avet Lifesciences	NEOSTIGMINE METHYSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	208230-001	Nov 25, 2022	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Gland Pharma Ltd	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	212968-002	Oct 16, 2019	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Nivagen Pharms Inc	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	212627-002	Nov 3, 2022	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Exela Pharma	BLOXIVERZ	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	204078-001	May 31, 2013	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fresenius Kabi Usa	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	203629-003	Sep 18, 2018	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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:	26
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	9
Patent Applications:	2,155
Formulation / Manufacturing:	see details
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