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Last Updated: August 8, 2020

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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 two branded drugs marketed by Avadel Legacy, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Be Pharms, Dr Reddys, Eurohlth Intl Sarl, Fresenius Kabi Usa, Gland Pharma Ltd, and Par Sterile Products, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for neostigmine methylsulfate. Eleven suppliers are listed for this compound.

Drug Prices for neostigmine methylsulfate

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Recent Clinical Trials for neostigmine methylsulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fayoum University HospitalPhase 4
Emory UniversityEarly Phase 1
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all neostigmine methylsulfate clinical trials

Pharmacology for neostigmine methylsulfate
Medical Subject Heading (MeSH) Categories for neostigmine methylsulfate

US Patents and Regulatory Information for neostigmine methylsulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Be Pharms NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 212512-002 May 13, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Eurohlth Intl Sarl NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 207042-001 Dec 28, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Amring Pharms NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 210989-002 Aug 22, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Amneal NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 210051-002 Jun 15, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Avadel Legacy BLOXIVERZ neostigmine methylsulfate SOLUTION;INTRAVENOUS 204078-001 May 31, 2013 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
Baxter
Moodys
Mallinckrodt
Express Scripts

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