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Last Updated: June 12, 2021

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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 Exela Pharma, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Be Pharms, Dr Reddys, Eurohlth Intl Sarl, Fresenius Kabi Usa, Gland Pharma Ltd, Hong Kong, and Par Sterile Products, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for neostigmine methylsulfate. Thirteen 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
Fondazione Policlinico Universitario Agostino Gemelli IRCCSN/A
Fayoum University HospitalPhase 4
Emory UniversityEarly Phase 1

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
Gland Pharma Ltd NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 212968-002 Oct 16, 2019 AP RX No No   Get Started Free   Get Started Free   Get Started Free
Par Sterile Products NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 208405-002 Apr 26, 2017 AP RX No No   Get Started Free   Get Started Free   Get Started Free
Dr Reddys NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 209135-002 Jul 10, 2018 AP RX No No   Get Started Free   Get Started Free   Get Started Free
>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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