Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 9, 2019

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Pyridostigmine bromide - Generic Drug Details

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What are the generic drug 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, Novitium Pharma, Alvogen, Impax Labs Inc, Rising, Ani Pharms Inc, Elysium, Impax Labs, Solvay, Us Army, and Zydus Pharms, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for pyridostigmine bromide. Sixteen suppliers are listed for this compound.

Recent Clinical Trials for pyridostigmine bromide

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

SponsorPhase
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranPhase 2
Vanderbilt University Medical CenterPhase 1
National Institutes of Health (NIH)Phase 0

See all pyridostigmine bromide clinical trials

Pharmacology for pyridostigmine bromide
Medical Subject Heading (MeSH) Categories for pyridostigmine bromide
Synonyms for pyridostigmine bromide
(1-methylpyridin-1-ium-3-yl) N,N-dimethylcarbamate bromide
(1-methylpyridin-1-ium-3-yl) N,N-dimethylcarbamate;bromide
1-Methyl-3-hydroxypyridinium bromide dimethylcarbamate
1-methyl-3-hydroxypyridiniumbromidedimethylcarbamate
101-26-8
3-(((dimethylamino)carbonyl)oxy)-1-methyl-pyridiniubromide
3-(((Dimethylamino)carbonyl)oxy)-1-methylpyridinium bromide
3-((Dimethylcarbamoyl)oxy)-1-methylpyridin-1-ium bromide
3-(Dimethylaminocarbonyloxy)-1-methylpyridinium bromide
3-(Dimethylcarbamoyloxy)-1-methylpyridinium Bromide
3-(Dimethylcarbamyloxy)-1-methylpyridinium bromide
3-(dimethylcarbamyloxy)-1-methylpyridiniumbromide
3-[(dimethylcarbamoyl)oxy]-1-methylpyridin-1-ium bromide
3-[[(Dimethylamino)carbonyl]oxy]-1-methylpyridinium bromide
3-{[(dimethylamino)carbonyl]oxy}-1-methylpyridinium bromide
3-Dimethylaminocarbonyloxy-N-methylpyridinium bromide
3-Dimethylcarbamoyloxy-1-methylpyridinium bromide;3-Dimethylcarbamoyloxy-1-methylpyridinium bromide
3-Hydroxy-1-methylpyridinium bromide dimethylcarbamate
3-Hydroxy-1-methylpyridinium bromide dimethylcarbamate (ester)
3-hydroxy-1-methylpyridiniumbromidedimethylcarbamate
3-hydroxy-1-methylpyridiniumbromidedimethylcarbamate(ester)
AB0013077
AB2000158
AC-8143
AC1L1P0M
AC1Q1RCO
AKOS015895321
AN-937
ANW-41310
AS-13164
BCP02148
Bromure de pyridostigmine
Bromure de pyridostigmine [INN-French]
Bromuro de piridostigmina
Bromuro de piridostigmina [INN-Spanish]
Carbamic acid, dimethyl-, ester with 3-hydroxy-1-methylpyridinium bromide
CAS-101-26-8
CCG-40306
CCRIS 6798
CHEBI:8666
CHEMBL812
CPD000058605
CS-2148
CTK3J2505
D00487
Dimethylcarbamic acid ester of 3-hydroxy-1-methylpyridinium bromide
dimethylcarbamicacidesterof3-hydroxy-1-methylpyridiniumbromide
DSSTox_CID_3540
DSSTox_GSID_23540
DSSTox_RID_77069
DTXSID9023540
EINECS 202-929-9
EU-0101035
FT-0081402
FT-0603307
H494
HMS1922M05
HMS2092P14
HMS2234D06
HMS3259M16
HMS3263O11
HMS3369P02
HMS3651G13
HMS500K09
HSDB 3924
HY-B0207A
I06-0719
Kalimin
Kalymin
KS-00000YPC
KSC492K0L
KVI301NA53
LP01035
LS-329
MCULE-9535630272
Mestinon
Mestinon (TN)
Mestinon bromide
Mestinon;Regonol
MFCD00079283
MLS000028385
MLS001074080
MolPort-003-666-466
N,N-dimethyl(1-methyl(3-pyridyloxy))carboxamide, bromide
N,N-DIMETHYLAMINOFORMIC ACID 3-PYRIDINYL ESTER
NC00581
NCGC00015862-07
NCGC00094324-01
NCGC00094324-02
NCGC00094324-03
NCGC00094324-04
NCGC00261720-01
NE58261
NSC-679759
NSC-758435
NSC679759
NSC758435
Opera_ID_420
P 9797
P1339
Pharmakon1600-01503240
Piridostigmina bromuro
Piridostigmina bromuro [DCIT]
PubChem15395
pybr
Pyridinium, 3-(((dimethylamino)carbonyl)oxy)-1-methyl-, bromide
Pyridinium, 3-[[(dimethylamino)carbonyl]oxy]-1-methyl-, bromide
Pyridinium, 3-hydroxy-1-methyl-, bromide, dimethylcarbamate (ester)
Pyridinium, 3-hydroxyl-1-methyl-, bromide, dimethylcarbamate
Pyridostigmine (bromide)
Pyridostigmine bromide (JP17/USP/INN)
Pyridostigmine Bromide (Mestinon)
Pyridostigmine bromide [USAN:INN:BAN:JAN]
Pyridostigmine bromide [USP:INN:BAN:JAN]
Pyridostigmine bromide, 98%
Pyridostigmine bromide, European Pharmacopoeia (EP) Reference Standard
Pyridostigmine bromide, United States Pharmacopeia (USP) Reference Standard
Pyridostigmini bromidum
Pyridostigmini bromidum [INN-Latin]
Q-201644
Regonal
Regonol
Ro 1-5130
RTR-000353
s1608
SAM002564227
SC-16827
SCHEMBL41147
SMR000058605
SPECTRUM1503240
SR-01000003072
SR-01000003072-2
SR-01000003072-4
ST24041332
ST51015114
SW199029-2
Tox21_111266
Tox21_111266_1
Tox21_501035
TR-000353
UNII-KVI301NA53
Z1541632810

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
Rising PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 205464-001 Aug 15, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 040512-002 Jul 20, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Alvogen PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 204737-001 Jun 26, 2015 AB RX No No   Start Trial   Start Trial   Start 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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Dow
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Colorcon
Harvard Business School

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