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.

Sponsor	Phase
University of Vermont Medical Center	Phase 2
Stefan Holubar MD MS FACS, FASCRS	Phase 2/Phase 3
Michael E. DeBakey VA Medical Center	Early Phase 1

Sponsor

Phase

University of Vermont Medical Center

Phase 2

Stefan Holubar MD MS FACS, FASCRS

Phase 2/Phase 3

Michael E. DeBakey VA Medical Center

Early Phase 1

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs	PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	TABLET;ORAL	040502-001	Apr 24, 2003	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msn	PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	SYRUP;ORAL	216512-001	Sep 21, 2023	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	REGONOL	pyridostigmine bromide	INJECTABLE;INJECTION	017398-001	Approved Prior to Jan 1, 1982	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs	PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	TABLET;ORAL	040502-002	Jun 28, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	MESTINON	pyridostigmine bromide	SYRUP;ORAL	015193-001	Approved Prior to Jan 1, 1982	AA	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alvogen	PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	TABLET, EXTENDED RELEASE;ORAL	204737-001	Jun 26, 2015	AB	RX	No	No	⤷ 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

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

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors