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Last Updated: December 6, 2019

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Pilocarpine hydrochloride - Generic Drug Details

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What are the generic sources for pilocarpine hydrochloride and what is the scope of freedom to operate?

Pilocarpine hydrochloride is the generic ingredient in four branded drugs marketed by Alcon, Novartis, Akorn Inc, Aurobindo Pharma Ltd, Impax Labs, Innogenix, Lannett Co Inc, Perrigo Pharma Intl, and Concordia, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for pilocarpine hydrochloride. Thirteen suppliers are listed for this compound.

Recent Clinical Trials for pilocarpine hydrochloride

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

SponsorPhase
Montefiore Medical CenterPhase 3
Massachusetts Eye and Ear InfirmaryEarly Phase 1
University of California, San DiegoN/A

See all pilocarpine hydrochloride clinical trials

Pharmacology for pilocarpine hydrochloride
Synonyms for pilocarpine hydrochloride
(+)-Pilocarpine hydrochloride
(3S-cis)-3-Ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl]-2(3H)-furanone hydrochloride
(3S,4R)-3-ethyl-4-((1-methyl-1H-imidazol-5-yl)methyl)dihydrofuran-2(3H)-one hydrochloride
(3S,4R)-3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]dihydrofuran-2(3H)-one hydrochloride
(3S,4R)-3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]oxolan-2-one hydrochloride
(3S,4R)-3-ethyl-4-[(1-methylimidazol-5-yl)methyl]-3,4,5-trihydrofuran-2-one, c hloride
(3S,4R)-3-ethyl-4-[(3-methylimidazol-4-yl)methyl]oxolan-2-one hydrochloride
(3S,4R)-3-ethyl-4-[(3-methylimidazol-4-yl)methyl]oxolan-2-one;hydrochloride
(3S,4R)-3-ethyl-4-[(3-methylimidazol-4-yl)methyl]tetrahydrofuran-2-one hydrochloride
(3S,4R)-3-Ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)methyl]-2(3H)-furanone Hydrochloride
(3S,4R)-4,5-Dihydro-3-ethyl-4-(1-methyl-1H-imidazol-5-ylmethyl)-2(3H)-furanone hydrochloride
0WW6D218XJ
2(3H)-Furanone, 3-ethyldihydro-4-((1-methyl-1H-imidazol-5-yl)methyl)-, hydrochloride (1:1), (3S,4R)-
2(3H)-Furanone, 3-ethyldihydro-4-((1-methyl-1H-imidazol-5-yl)methyl)-, monohydrochloride, (3S-cis)-
2(3H)-Furanone, 3-ethyldihydro-4-((1-methyl-1H-imidazol-5-yl)methyl)-, monohydrochloride, (3S,4R)-
2(3H)-Furanone, monohydrochloride, (3S-cis)-
3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]dihydro-2(3H)-furanone hydrochloride
54-71-7
5881AF
AC1L1LEC
AC1Q3EQS
Adsorbocarpine
AI3-61859
Akarpine
AKOS005267231
Almocarpine
Ami-pilo
Amistura P
AN-41661
ARONIS24309
BBC/465
BC245589
CCG-100757
CHEBI:141029
CHEMBL1200330
component of Epicar
component of Pilocar
CPD000059053
CS-2973
D02200
DTXSID2041096
EINECS 200-212-5
Epicar
EU-0100950
FT-0631237
HY-B0726
Isopto carpine
Isopto carpine (TN)
Isopto-carpine
Isoptocarpine
KB-62493
KS-0000478G
LP00950
LS-109779
MFCD00012722
Mi-Pilo
MI-Pilo Ophth Sol
Mistura P
MLS000069454
MLS000758210
MLS001076314
MLS001424017
MolPort-003-939-125
NC00007
NCGC00094254-01
NCGC00261635-01
NSC 5746
NSC-5746
NSC5746
Opera_ID_1616
P 6503
PILO
Pilocar
Pilocar SMP
Pilocarpal
Pilocarpin Hcl
Pilocarpine (Hydrochloride)
Pilocarpine chloride
Pilocarpine HCl
Pilocarpine hydrochloride (JP17/USP)
Pilocarpine hydrochloride [USAN:JAN]
Pilocarpine hydrochloride [USP:JAN]
Pilocarpine hydrochloride, >=98% (titration), powder
Pilocarpine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Pilocarpine hydrochloride, meets USP testing specifications
Pilocarpine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Pilocarpine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Pilocarpine hydrochlororide
Pilocarpine monohydrochloride
Pilocarpine muriate
pilocarpine-hcl
Pilocarpine, hydrochloride
PILOCARPINE, MONOHYDROCHLORIDE
Pilocel
Pilokarpin monohydrochloride
Pilomiotin
Pilopine
PILOPINE HS
Pilopine HS (TN)
Pilopine HS Gel
Pilovisc
regid855931
RNAICSBVACLLGM-GNAZCLTHSA-N
s4231
Salagen
SAM001246962
Sanpilo (TN)
SBB006456
SC-47863
SC-50867
SCHEMBL41427
SMR000059053
Sno pilo
Spersacarpine hydrochloride
SR-01000000054
SR-01000000054-3
SR-01000075339-1
ST057163
SW196587-4
Tox21_500950
UNII-0WW6D218XJ
WLN: T5OVTJ C2 D1- DT5N CNJ C1 &GH

US Patents and Regulatory Information for pilocarpine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Concordia SALAGEN pilocarpine hydrochloride TABLET;ORAL 020237-001 Mar 22, 1994 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis ISOPTO CARPINE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 200890-003 Jun 22, 2010 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis ISOPTO CARPINE pilocarpine hydrochloride SOLUTION;OPHTHALMIC 200890-002 Jun 22, 2010 AT RX Yes No   Start Trial   Start Trial   Start Trial
Concordia SALAGEN pilocarpine hydrochloride TABLET;ORAL 020237-002 Apr 18, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Impax Labs PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077248-002 Mar 31, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Innogenix PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 076963-001 Dec 22, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc PILOCARPINE HYDROCHLORIDE pilocarpine hydrochloride TABLET;ORAL 077220-002 May 6, 2009 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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