Last Updated: June 22, 2026

NEOSTIGMINE Drug Patent Profile


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

Neostigmine is a drug marketed by Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Avet Lifesciences, Be Pharms, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Meitheal, Nivagen Pharms Inc, Ph Health, Regcon Holdings, and Sagent Pharms Inc. and is included in nineteen NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Neostigmine

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

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Summary for NEOSTIGMINE
US Patents:0
Applicants:17
NDAs:19
Drug Prices: Drug price information for NEOSTIGMINE
DailyMed Link:NEOSTIGMINE at DailyMed

US Patents and Regulatory Information for NEOSTIGMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ph Health NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 208405-001 Apr 26, 2017 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Meitheal NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 212804-001 Apr 5, 2021 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ph Health NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 208405-002 Apr 26, 2017 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Meitheal NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 212804-002 Apr 5, 2021 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Am Regent NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 209182-001 May 4, 2018 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Eugia Pharma NEOSTIGMINE METHYLSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 213244-001 Nov 2, 2023 DISCN 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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