CYCLOPENTOLATE HYDROCHLORIDE - Generic Drug Details
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What are the generic drug 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, Saptalis Pharms, 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: | 10 |
Patent Applications: | 1,736 |
Formulation / Manufacturing: | see details |
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
Sponsor | Phase |
---|---|
Islamic Hospital, Jordan | Phase 4 |
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Phase 4 |
Shanghai Eye Disease Prevention and Treatment Center | Phase 4 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pharmafair | PENTOLAIR | cyclopentolate hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 088643-001 | Feb 9, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Alcon Labs Inc | CYCLOGYL | cyclopentolate hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 084110-001 | Approved Prior to Jan 1, 1982 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Epic Pharma Llc | AK-PENTOLATE | cyclopentolate hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 085555-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 |