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Last Updated: September 23, 2020

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CYCLOPENTOLATE HYDROCHLORIDE Drug Profile

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Which patents cover Cyclopentolate Hydrochloride, and when can generic versions of Cyclopentolate Hydrochloride launch?

Cyclopentolate Hydrochloride is a drug marketed by Akorn Inc, Alcon Pharms Ltd, and Sola Barnes Hind. and is included in four NDAs.

The generic ingredient in CYCLOPENTOLATE HYDROCHLORIDE is cyclopentolate hydrochloride. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cyclopentolate hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Cyclopentolate Hydrochloride

A generic version of CYCLOPENTOLATE HYDROCHLORIDE was approved as cyclopentolate hydrochloride by AKORN INC on December 9th, 2015.

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Summary for CYCLOPENTOLATE HYDROCHLORIDE
Drug patent expirations by year for CYCLOPENTOLATE HYDROCHLORIDE
Recent Clinical Trials for CYCLOPENTOLATE HYDROCHLORIDE

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

SponsorPhase
Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePhase 4
Shanghai Eye Disease Prevention and Treatment CenterPhase 4
Cairo UniversityPhase 3

See all CYCLOPENTOLATE HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for CYCLOPENTOLATE HYDROCHLORIDE

US Patents and Regulatory Information for CYCLOPENTOLATE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn Inc CYCLOPENTOLATE HYDROCHLORIDE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 205937-001 Dec 9, 2015 AT RX No No   Start Trial   Start Trial   Start Trial
Sola Barnes Hind CYCLOPENTOLATE HYDROCHLORIDE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084863-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Alcon Pharms Ltd CYCLOPENTOLATE HYDROCHLORIDE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 089162-001 Jan 24, 1991 DISCN No No   Start Trial   Start Trial   Start Trial
Sola Barnes Hind CYCLOPENTOLATE HYDROCHLORIDE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084150-001 Approved Prior to Jan 1, 1982 DISCN 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

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Baxter
Dow
Moodys
Boehringer Ingelheim

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