Viewing data from:

MESTINON

NDA

PYRIDOSTIGMINE BROMIDE | N015193 | BAUSCH HEALTH US LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Rising Pharma Holdings. Inc. FDA-2025-P-4986 Rising Pharma Holdings, Inc. filed a suitability petition pursuant to Section 505(j)(2)(C) of the FD&C Act requesting permission to submit an ANDA for Pyridostigmine Bromide Oral Solution, USP 120 mg/5 mL, a higher strength than the reference listed drug MESTINON Oral Solution, USP 60 mg/5 mL (NDA 0	Suitability	2025-10-09	Open	Rising Pharma Holdings. Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs8 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

BAUSCH HEALTH US LLCPYRIDOSTIGMINE BROMIDE

DMF 55051984

PATHEON AUSTRIA GMBH AND CO KGPYRIDOSTIGMINE BROMIDE

DMF 105931993

PROCOS SPAPYRIDOSTIGMINE BROMIDE

DMF 160352002

MAITHRI LABORATORIES PRIVATE LTDPYRIDOSTIGMINE BROMIDE USP

DMF 350242020

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDPYRIDOSTIGMINE BROMIDE

DMF 393792024

GLOBAL CALCIUM PRIVATE LTDPYRIDOSTIGMINE BROMIDE USP

DMF 396372024

HOFFMANN LA ROCHE INCInactivePYRIDOSTIGMINE BROMIDE

DMF 69391987

DELMAR CHEMICALS INCInactivePYRIDOSTIGMINE BROMIDE

DMF 88001990

UNICHEM LABORATORIES LTDInactivePYRIDOSTIGMINE BROMIDE

DMF 89521991

CILAG CHEMIE AGInactivePYRIDOSTIGMINE BROMIDE

DMF 90291991

NV ORGANONInactivePYRIDOSTIGMINE BROMIDE

DMF 92161991

HELSINN ADVANCED SYNTHESIS SAInactivePYRIDOSTIGMINE BROMIDE

DMF 108771994

ROCHE PRODUCTS LTDInactivePYRIDOSTIGMINE BROMIDE TABLETS USP 30MG

DMF 119721996

POLYCARBON INDUSTRIES INC DBA PCI SYNTHESISInactivePYRIDOSTIGMINE BROMIDE USP

DMF 156652001

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 30, 2019	SUPPL -27	View Letter (PDF)
May 22, 2002	SUPPL -20	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60MG/5ML

RLDAA

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.