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Last Updated: May 21, 2024

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

SponsorPhase
University of Alabama at BirminghamPhase 4
American University of Beirut Medical CenterPhase 2
Walter Reed Army Medical CenterN/A

See all apraclonidine hydrochloride clinical trials

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
Rising APRACLONIDINE HYDROCHLORIDE apraclonidine hydrochloride SOLUTION/DROPS;OPHTHALMIC 077764-001 Mar 12, 2009 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Harrow Eye IOPIDINE apraclonidine hydrochloride SOLUTION/DROPS;OPHTHALMIC 019779-001 Dec 31, 1987 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Harrow Eye IOPIDINE apraclonidine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020258-001 Jul 30, 1993 AT RX Yes Yes ⤷  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

Expired US Patents for apraclonidine hydrochloride

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

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