Apraclonidine hydrochloride - Generic Drug Details

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What are the generic drug sources for apraclonidine hydrochloride and what is the scope of freedom to operate?

Apraclonidine hydrochloride is the generic ingredient in two branded drugs marketed by Rising and Harrow Eye, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for apraclonidine hydrochloride. Two suppliers are listed for this compound.

Summary for apraclonidine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	3
Patent Applications:	606
What excipients (inactive ingredients) are in apraclonidine hydrochloride?	apraclonidine hydrochloride excipients list
DailyMed Link:	apraclonidine hydrochloride at DailyMed

Recent Clinical Trials for apraclonidine hydrochloride

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 4
American University of Beirut Medical Center	Phase 2
Walter Reed Army Medical Center	N/A

See all apraclonidine hydrochloride clinical trials

Pharmacology for apraclonidine hydrochloride

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for apraclonidine hydrochloride

US Patents and Regulatory Information for apraclonidine 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
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020258-001	Jul 30, 1993	AT	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	APRACLONIDINE HYDROCHLORIDE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	077764-001	Mar 12, 2009	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 apraclonidine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020258-001	Jul 30, 1993	⤷ Sign Up	⤷ Sign Up
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987	⤷ Sign Up	⤷ Sign Up
Harrow Eye	IOPIDINE	apraclonidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019779-001	Dec 31, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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