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Last Updated: August 8, 2020

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Pyridostigmine bromide - Generic Drug Details

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What are the generic sources for pyridostigmine bromide and what is the scope of patent protection?

Pyridostigmine bromide is the generic ingredient in three branded drugs marketed by Bausch, Sandoz Inc, Amneal Pharms Llc, Invatech, Novitium Pharma, Alvogen, Impax Labs Inc, Rising, Ani Pharms Inc, Elysium, Impax Labs, Solvay, Us Army, and Zydus Pharms, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for pyridostigmine bromide. Eighteen suppliers are listed for this compound.

Recent Clinical Trials for pyridostigmine bromide

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

SponsorPhase
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranPhase 2/Phase 3
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranPhase 2
Vanderbilt University Medical CenterPhase 1

See all pyridostigmine bromide clinical trials

Pharmacology for pyridostigmine bromide
Medical Subject Heading (MeSH) Categories for pyridostigmine bromide

US Patents and Regulatory Information for pyridostigmine bromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms Inc PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 040512-002 Jul 20, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Elysium PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 211181-001 Jul 20, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Rising PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 205464-001 Aug 15, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Novitium Pharma PYRIDOSTIGMINE BROMIDE pyridostigmine bromide SYRUP;ORAL 211694-001 Mar 8, 2019 AA RX 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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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
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Merck
Moodys

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