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. One supplier is 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:	1
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

Sponsor	Phase
Alcon Research	Phase 4
Aston University	Phase 4
University of Worcester	Phase 4

See all epinastine hydrochloride clinical trials

Generic filers with tentative approvals for EPINASTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	0.05%	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

Drug Class	Adrenergic Receptor Agonist Histamine-1 Receptor Inhibitor
Mechanism of Action	Adrenergic Agonists Histamine H1 Receptor Antagonists
Physiological Effect	Decreased Histamine Release

Anatomical Therapeutic Chemical (ATC) Classes for epinastine hydrochloride

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	EPINASTINE HYDROCHLORIDE	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	203384-001	Dec 7, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Somerset Theraps Llc	EPINASTINE HYDROCHLORIDE	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	090951-001	Oct 31, 2011	AT	RX	No	Yes	⤷ 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
>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 epinastine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ELESTAT	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021565-001	Oct 16, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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