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Generated: April 23, 2017

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Epinastine hydrochloride - Generic Drug Details

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

Epinastine hydrochloride
is the generic ingredient in two branded drugs marketed by Apotex, Sun Pharm Inds, Somerset Theraps Llc, Allergan, Breckenridge Pharm, and Sandoz Inc, and is included in six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. 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

Drug Master File Entries: see list6
Suppliers / Packagers: see list6
Bulk Api Vendors: see list41
Clinical Trials: see list988
Patent Applications: see list409
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC090919-001Oct 31, 2011ATRXNoNo► Subscribe► Subscribe
Breckenridge Pharm
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC090870-001Mar 14, 2011ATRXNoNo► Subscribe► Subscribe
Sandoz Inc
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC203384-001Dec 7, 2016ATRXNoNo► Subscribe► Subscribe
Sun Pharm Inds
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC091626-001Oct 31, 2011ATRXNoNo► Subscribe► Subscribe
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021565-001Oct 16, 2003ATRXYesYes► Subscribe► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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