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Last Updated: March 28, 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, 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.

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
Alexandria UniversityPhase 4
Kasr El Aini HospitalPhase 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
Indoco NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 210652-002 Oct 1, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 216206-001 Jul 13, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 207042-002 Dec 28, 2015 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 213244-002 Nov 2, 2023 AP RX No No ⤷  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

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