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Last Updated: March 19, 2024

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, Amneal, Milla Pharms, MSN, Novitium Pharma, Rising, Alvogen, Impax Labs Inc, Ani Pharms, Eywa, Impax Labs, Solvay, Us Army, and Zydus Pharms, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for pyridostigmine bromide. Twenty-one 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
University of Vermont Medical CenterPhase 2
Stefan Holubar MD MS FACS, FASCRSPhase 2/Phase 3
Baylor College of MedicineEarly Phase 1

See all pyridostigmine bromide clinical trials

Pharmacology for pyridostigmine bromide
Medical Subject Heading (MeSH) Categories for pyridostigmine bromide
Anatomical Therapeutic Chemical (ATC) Classes 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
Alvogen PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 204737-001 Jun 26, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch MESTINON pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 011665-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Solvay PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 089572-001 Nov 27, 1990 DISCN 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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