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Last Updated: November 19, 2024

GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE - Generic Drug Details


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What are the generic drug sources for glycopyrrolate; neostigmine methylsulfate and what is the scope of freedom to operate?

Glycopyrrolate; neostigmine methylsulfate is the generic ingredient in one branded drug marketed by Azurity and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE
Generic Entry Date for GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
James J. Peters Veterans Affairs Medical CenterPhase 1

See all GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE clinical trials

US Patents and Regulatory Information for GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity PREVDUO glycopyrrolate; neostigmine methylsulfate SOLUTION;INTRAVENOUS 216903-001 Feb 23, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity PREVDUO glycopyrrolate; neostigmine methylsulfate SOLUTION;INTRAVENOUS 216903-001 Feb 23, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Azurity PREVDUO glycopyrrolate; neostigmine methylsulfate SOLUTION;INTRAVENOUS 216903-001 Feb 23, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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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