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
| Sponsor | Phase |
|---|---|
| Yarmouk University | Phase 4 |
| Jordan University of Science and Technology | Phase 4 |
| Islamic Hospital, Jordan | Phase 4 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alcon Labs Inc | CYCLOMYDRIL | cyclopentolate hydrochloride; phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 084300-001 | Approved Prior to Jan 1, 1982 | RX | No | Yes | ⤷ 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 | ||||
| Bausch And Lomb | PENTOLAIR | cyclopentolate hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 040075-001 | Apr 29, 1994 | AT | RX | No | No | ⤷ 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 | ||||
| Sciegen Pharms Inc | CYCLOPENTOLATE HYDROCHLORIDE | cyclopentolate hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 205937-001 | Dec 9, 2015 | DISCN | No | No | ⤷ 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 |
