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Last Updated: July 10, 2020

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Apraclonidine hydrochloride - Generic Drug Details

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What are the generic 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 Akorn Inc and Novartis, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for apraclonidine hydrochloride. Three suppliers are listed for this compound.

Summary for apraclonidine hydrochloride
Recent Clinical Trials for apraclonidine hydrochloride

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SponsorPhase
Walter Reed Army Medical CenterN/A

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Pharmacology for apraclonidine hydrochloride

US Patents and Regulatory Information for apraclonidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis IOPIDINE apraclonidine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020258-001 Jul 30, 1993 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis IOPIDINE apraclonidine hydrochloride SOLUTION/DROPS;OPHTHALMIC 019779-001 Dec 31, 1987 RX Yes Yes   Start Trial   Start Trial   Start Trial
Akorn Inc APRACLONIDINE HYDROCHLORIDE apraclonidine hydrochloride SOLUTION/DROPS;OPHTHALMIC 077764-001 Mar 12, 2009 AT RX No No   Start Trial   Start Trial   Start Trial
>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

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

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Serving leading biopharmaceutical companies globally:

Dow
McKinsey
Harvard Business School
Moodys
AstraZeneca
Medtronic

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