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Last Updated: November 22, 2024

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 Epic Pharma Llc, Rising, Alcon Labs Inc, Alcon Pharms Ltd, Sciegen Pharms Inc, 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. Three suppliers are listed for this compound.

Summary for cyclopentolate hydrochloride
US Patents:0
Tradenames:6
Applicants:8
NDAs:14
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 84
Clinical Trials: 11
Patent Applications: 1,641
What excipients (inactive ingredients) are in cyclopentolate hydrochloride?cyclopentolate hydrochloride excipients list
DailyMed Link:cyclopentolate hydrochloride at DailyMed
Recent Clinical Trials for cyclopentolate hydrochloride

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

SponsorPhase
Jordan University of Science and TechnologyPhase 4
Yarmouk UniversityPhase 4
Islamic Hospital, JordanPhase 4

See all cyclopentolate hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for cyclopentolate hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes 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
Bausch And Lomb PENTOLAIR cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 040075-001 Apr 29, 1994 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc CYCLOGYL cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084109-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharmafair PENTOLAIR cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 088150-001 Feb 25, 1983 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sola Barnes Hind CYCLOPENTOLATE HYDROCHLORIDE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084150-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alcon Labs Inc CYCLOGYL cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 084108-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising AKPENTOLATE cyclopentolate hydrochloride SOLUTION/DROPS;OPHTHALMIC 040164-001 Jan 13, 1997 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

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