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Last Updated: July 29, 2021

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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 freedom to operate?

Pyridostigmine bromide is the generic ingredient in three branded drugs marketed by Bausch, Sandoz Inc, Amneal, Elysium, Novitium Pharma, Alvogen, Impax Labs Inc, Rising, Ani Pharms, Eywa, 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. Seventeen suppliers are listed for this compound.

Summary for PYRIDOSTIGMINE BROMIDE
Recent Clinical Trials for PYRIDOSTIGMINE BROMIDE

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

SponsorPhase
Michael Debakey Veterans Affairs Medical CenterEarly Phase 1
Baylor College of MedicineEarly Phase 1
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranPhase 2/Phase 3

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
Elysium PYRIDOSTIGMINE BROMIDE pyridostigmine bromide SYRUP;ORAL 208797-001 Jan 9, 2020 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bausch MESTINON pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 011665-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sandoz Inc REGONOL pyridostigmine bromide INJECTABLE;INJECTION 017398-001 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Eywa PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 211181-002 May 14, 2019 RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Rising PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 205464-001 Aug 15, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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:

Baxter
Merck
Moodys
McKesson
AstraZeneca
Harvard Business School

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