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Last Updated: August 14, 2020

DrugPatentWatch Database Preview

Cyclopentolate hydrochloride - Generic Drug Details

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

Cyclopentolate hydrochloride is the generic ingredient in six branded drugs marketed by Akorn, Alcon Labs Inc, Akorn Inc, Alcon Pharms Ltd, Sola Barnes Hind, Bausch And Lomb, and Pharmafair, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for cyclopentolate hydrochloride. Five suppliers are listed for this compound.

Summary 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
Alcon Labs Inc CYCLOGYL cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084110-001 Approved Prior to Jan 1, 1982 AT RX No Yes   Start Trial   Start Trial   Start Trial
Akorn AKPENTOLATE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 040164-001 Jan 13, 1997 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
Akorn AKPENTOLATE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 040165-001 Jan 13, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Akorn Inc CYCLOPENTOLATE HYDROCHLORIDE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 205937-001 Dec 9, 2015 AT RX No No   Start Trial   Start Trial   Start Trial
Pharmafair PENTOLAIR cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 088150-001 Feb 25, 1983 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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