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

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Last Updated: December 6, 2019

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Emedastine difumarate - Generic Drug Details

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What are the generic sources for emedastine difumarate and what is the scope of patent protection?

Emedastine difumarate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for emedastine difumarate. One supplier is listed for this compound.

Recent Litigation for emedastine difumarate

Identify potential future generic entrants

District Court Litigation
Case NameDate
AstraZeneca Pharmaceuticals LP v. Apotex Inc.2007-12-11
MedPointe Healthcare Inc. v. Apotex Inc.2007-04-17

See all emedastine difumarate litigation

Pharmacology for emedastine difumarate
Synonyms for emedastine difumarate
(E)-but-2-enedioic acid; 1-(2-ethoxyethyl)-2-(4-methyl-1,4-diazepan-1-yl)benzimidazole
(E)-but-2-enedioic acid;1-(2-ethoxyethyl)-2-(4-methyl-1,4-diazepan-1-yl)benzimidazole
1-(2-Ethoxyethyl)-2-(4-methyl-1-homopiperazinyl)benzimidazole difumarate
1-(2-Ethoxyethyl)-2-(4-methyl-1,4-diazepan-1-yl)-1H-benzo[d]imidazole difumarate
1-(2-ethoxyethyl)-2-(4-methyl-1,4-diazepan-1-yl)benzimidazole; fumaric acid
1-(2-Ethoxyethyl)-2-(4-methylhexahydro-1H-1,4-diazepin-1-yl)benzimidazole fumarate (1:2)
1-(2-Ethoxyethyl)-2-(hexahydro-4-methyl-1H-1,4-diazepin-1-yl)benzimidazole fumarate (1:2)
1H-Benzimidazole, 1-(2-ethoxyethyl)-2-(hexahydro-4-methyl-1H-1,4-diazepin-1-yl)-, (E)-2-butenedioate (1:2)
42MB94QOSM
87233-61-2 (Parent)
87233-62-3
AC-391
AC1NR057
AKOS022185076
AL 3432A
AL-3432A
AN-15868
API0005026
BC226236
Benzimidazole, 1-(2-ethoxyethyl)-2-(4-methylhexahydro-1H-1,4-diazepin-1-yl)-, fumarate (1:2)
CAS-87233-62-3
CCG-220591
CHEMBL2103739
D02249
Daren
Daren (TN)
DSSTox_CID_26911
DSSTox_GSID_46911
DSSTox_RID_82009
DTXSID2046911
E0936
Emadine (TN)
Emedastine difumarate (JP17/USP)
Emedastine difumarate [USAN:USP:JAN]
Emedastine fumarate
HMS3713H04
KB-2413
KG-2413
LY 188695
LY-188695
NCGC00181341-01
NCGC00181341-02
Rapimine
Remicut
SC-94330
SCHEMBL41384
SCHEMBL41386
SR-01000872706
SR-01000872706-1
Tox21_112800
Tox21_112800_1
UNII-42MB94QOSM

US Patents and Regulatory Information for emedastine difumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis EMADINE emedastine difumarate SOLUTION/DROPS;OPHTHALMIC 020706-001 Dec 29, 1997 DISCN Yes 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

Expired US Patents for emedastine difumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EMADINE emedastine difumarate SOLUTION/DROPS;OPHTHALMIC 020706-001 Dec 29, 1997   Start Trial   Start Trial
Novartis EMADINE emedastine difumarate SOLUTION/DROPS;OPHTHALMIC 020706-001 Dec 29, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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