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Last Updated: November 2, 2024

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.

Summary 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
Seoul National University HospitalN/A
Kasr El Aini HospitalPhase 4
Alexandria UniversityPhase 4

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 212512-001 May 13, 2019 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Caplin NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 213074-001 Apr 20, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meitheal NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 212804-001 Apr 5, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Umedica NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 212627-001 Nov 3, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 213244-001 Nov 2, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Avet Lifesciences NEOSTIGMINE METHYSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 208230-002 Nov 25, 2022 AP RX No No ⤷  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

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