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Last Updated: March 28, 2024

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 Allergan, Apotex, Breckenridge, Chartwell Rx, Epic Pharma Llc, 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 five drug master file entries for epinastine hydrochloride. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for epinastine hydrochloride
US Patents:0
Tradenames:2
Applicants:7
NDAs:7
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 107
Clinical Trials: 15
Patent Applications: 564
What excipients (inactive ingredients) are in epinastine hydrochloride?epinastine hydrochloride excipients list
DailyMed Link:epinastine hydrochloride at DailyMed
Recent Clinical Trials for epinastine hydrochloride

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

SponsorPhase
Alcon ResearchPhase 4
University of WorcesterPhase 4
Aston UniversityPhase 4

See all epinastine hydrochloride clinical trials

Generic filers with tentative approvals for EPINASTINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.05%SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for epinastine hydrochloride
Paragraph IV (Patent) Challenges for EPINASTINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ELESTAT Ophthalmic Solution epinastine hydrochloride 0.05% 021565 1 2008-10-14

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
Somerset Theraps Llc EPINASTINE HYDROCHLORIDE epinastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 090951-001 Oct 31, 2011 AT RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Breckenridge EPINASTINE HYDROCHLORIDE epinastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 090870-001 Mar 14, 2011 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex EPINASTINE HYDROCHLORIDE epinastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 090919-001 Oct 31, 2011 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc EPINASTINE HYDROCHLORIDE epinastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 204055-001 May 5, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds EPINASTINE HYDROCHLORIDE epinastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 091626-001 Oct 31, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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