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Last Updated: August 8, 2020

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NEOSTIGMINE METHYLSULFATE Drug Profile

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When do Neostigmine Methylsulfate patents expire, and what generic alternatives are available?

Neostigmine Methylsulfate is a drug marketed by 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 ten NDAs.

The generic ingredient in NEOSTIGMINE METHYLSULFATE is neostigmine methylsulfate. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Neostigmine Methylsulfate

A generic version of NEOSTIGMINE METHYLSULFATE was approved as neostigmine methylsulfate by FRESENIUS KABI USA on January 8th, 2015.

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Drug patent expirations by year for NEOSTIGMINE METHYLSULFATE
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
Am Regent NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 209182-001 May 4, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 212968-001 Oct 16, 2019 AP RX No No   Start Trial   Start Trial   Start Trial
Amring Pharms NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 210989-001 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
Dr Reddys NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 209135-002 Jul 10, 2018 AP RX No No   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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