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Generated: July 19, 2018

DrugPatentWatch Database Preview

Epinastine hydrochloride - Generic Drug Details

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What are the generic sources for epinastine hydrochloride and what is the scope of epinastine hydrochloride patent protection?

Epinastine hydrochloride
is the generic ingredient in two branded drugs marketed by Allergan, Akorn, Apotex, Breckenridge Pharm, Casi Pharms Inc, Somerset Theraps Llc, and Sun Pharm Inds, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for epinastine hydrochloride. Six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for epinastine hydrochloride
Synonyms for epinastine hydrochloride
(13bRS)-9,13b-Dihydro-1H-dibenzo[c,f]imidazo[1,5-a]azepin-3-amine hydrochloride
108929-04-0
3-Amino-9,13b-dihydro-1H-dibenz(c,f)imidazo(1,5-a)azepine monohydrochloride
3-Amino-9,13b-dihydro-1H-dibenzo[c,f]imidazo[1,5-a]azepine Hydrochloride
80012-43-7 (Parent)
80012-44-8
9,13b-Dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepin-3-amine Hydrochloride
9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepin-3-amine, monohydrochloride
9,13b-Dihydro-1H-dibenz[cf]imidazo[1,5-a]azepine hydrochloride
9,13b-dihydro-1H-dibenzo[c,f]imidazo[1,5-a]azepin-3-amine hydrochloride
AC-1491
AC1L4HSC
AKOS015967222
Alesion
Alesion (TN)
AN-14853
ANW-43039
BC220918
C16H15N3.HCl
C16H16ClN3
CAS-108929-04-0
CCG-221805
CHEBI:51037
CHEMBL1200491
CTK8B3730
D01713
DE-114
DSSTox_CID_26502
DSSTox_GSID_46502
DSSTox_RID_81671
DTXSID1046502
E0799
Elestat
Elestat (TN)
Epinastin HCl
epinastin hydrochloride
Epinastine HCl
Epinastine hydrochloride (JAN)
Epinastine hydrochloride [JAN]
Epinastine hydrochloride for system suitability, European Pharmacopoeia (EP) Reference Standard
Epinastine hydrochloride, >=98% (HPLC), solid
Epinastine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Epinastine monohydrochloride
Epinastinehydrochloride
EX-A1004
Flurinol
FT-0631049
FT-0700527
HMS3652N21
IH-Dibenz(c,f)imidazo(1,5-a)azepin-3-amine, 9,13b-dihydro-, hydrochloride
IH-Dibenz(c,f)imidazo(1,5-a)azepin-3-amine, 9,13b-dihydro-, monohydrochloride
J-002209
KS-1159
LP00501
LS-60567
MFCD00865648
MFCD00933434
MolPort-005-940-901
NCGC00165791-02
NCGC00165791-04
NCGC00261186-01
PubChem1940
Relestat
RTR-002009
s4253
SCHEMBL122749
Tox21_112263
Tox21_112263_1
Tox21_500501
TR-002009
VKXSGUIOOQPGAF-UHFFFAOYSA-N
WAL 801 CL
WAL 801CL
WAL-801CL
Tentative approvals for EPINASTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up0.05%SOLUTION; OPHTHALMIC

US Patents and Regulatory Information for epinastine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Breckenridge Pharm EPINASTINE HYDROCHLORIDE epinastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 090870-001 Mar 14, 2011 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Akorn EPINASTINE HYDROCHLORIDE epinastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204055-001 May 5, 2017 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex EPINASTINE HYDROCHLORIDE epinastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 090919-001 Oct 31, 2011 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds EPINASTINE HYDROCHLORIDE epinastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 091626-001 Oct 31, 2011 AT RX 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

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Chubb
Healthtrust
Cipla
Cantor Fitzgerald
Baxter
UBS
Teva
QuintilesIMS

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