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Last Updated: November 4, 2024

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, Amneal, Milla Pharms, MSN, Novitium Pharma, Rising, Alvogen, Impax Labs Inc, Ani Pharms, Impax Labs, MLV, 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-two suppliers are listed for this compound.

Summary for PYRIDOSTIGMINE BROMIDE
US Patents:0
Tradenames:3
Applicants:15
NDAs:20
Drug Master File Entries: 11
Finished Product Suppliers / Packagers: 22
Raw Ingredient (Bulk) Api Vendors: 117
Clinical Trials: 21
Patent Applications: 1,899
What excipients (inactive ingredients) are in PYRIDOSTIGMINE BROMIDE?PYRIDOSTIGMINE BROMIDE excipients list
DailyMed Link:PYRIDOSTIGMINE BROMIDE at DailyMed
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
Michael E. DeBakey VA Medical CenterEarly 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
Bausch MESTINON pyridostigmine bromide TABLET;ORAL 009829-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 040512-002 Jul 20, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novitium Pharma PYRIDOSTIGMINE BROMIDE pyridostigmine bromide SYRUP;ORAL 211694-001 Mar 8, 2019 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 040502-001 Apr 24, 2003 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch MESTINON pyridostigmine bromide INJECTABLE;INJECTION 009830-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Solvay PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 089572-001 Nov 27, 1990 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  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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