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Epinastine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for epinastine hydrochloride?

Epinastine hydrochloride is the generic ingredient in two branded drugs marketed by Apotex, Sun Pharm Inds, Somerset Theraps Llc, Allergan, Breckenridge Pharm, and Alcon Res Ltd, and is included in six 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 Generic Name: epinastine hydrochloride

Tradenames:2
Patents:1
Applicants:6
NDAs:6
Drug Master File Entries: see list6
Suppliers / Packagers: see list6
Bulk Api Vendors: see list41
Clinical Trials: see list988
Patent Applications: see list300
Therapeutic Class:Ophthalmic Agents
Drug Prices:see low prices
DailyMed Link:epinastine hydrochloride at DailyMed

Pharmacology for Ingredient: epinastine hydrochloride

Tentative approvals for EPINASTINE HYDROCHLORIDE

Applicant Application No. Form Dosage
► Subscribe► SubscribeSOLUTION; OPHTHALMIC0.05%
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
ELESTAT
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021565-001Oct 16, 2003RXYesYes► Subscribe► Subscribe
Somerset Theraps Llc
EPINASTINE HYDROCHLORIDE
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC090951-001Oct 31, 2011RXNoNo► Subscribe► Subscribe
Apotex
EPINASTINE HYDROCHLORIDE
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC090919-001Oct 31, 2011RXNoNo► Subscribe► Subscribe
Alcon Res Ltd
EPINASTINE HYDROCHLORIDE
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC203384-001Dec 7, 2016RXNoNo► Subscribe► Subscribe
Breckenridge Pharm
EPINASTINE HYDROCHLORIDE
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC090870-001Mar 14, 2011RXNoNo► Subscribe► Subscribe
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