DORZOLAMIDE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Dorzolamide Hydrochloride, and what generic alternatives are available?
Dorzolamide Hydrochloride is a drug marketed by Alembic, Am Regent, Bausch And Lomb, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Micro Labs, Rubicon, Sandoz, Teva Pharms, Zambon Spa, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Ingenus Pharms Llc, and Somerset. and is included in thirty-two NDAs.
The generic ingredient in DORZOLAMIDE HYDROCHLORIDE is dorzolamide hydrochloride; timolol maleate. There are fifteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dorzolamide Hydrochloride
A generic version of DORZOLAMIDE HYDROCHLORIDE was approved as dorzolamide hydrochloride; timolol maleate by HIKMA on October 28th, 2008.
Summary for DORZOLAMIDE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 32 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 56 |
| Patent Applications: | 385 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | DORZOLAMIDE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for DORZOLAMIDE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laboratorios Poen | Phase 4 |
| Shahid Beheshti University of Medical Sciences | Phase 2/Phase 3 |
| Salus University | Phase 4 |
Pharmacology for DORZOLAMIDE HYDROCHLORIDE
| Drug Class | Carbonic Anhydrase Inhibitor |
| Mechanism of Action | Carbonic Anhydrase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for DORZOLAMIDE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DORZOLAMIDE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TRUSOPT | Ophthalmic Solution | dorzolamide hydrochloride | 2% | 020408 | 1 | 2005-10-11 |
US Patents and Regulatory Information for DORZOLAMIDE HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zambon Spa | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 091180-001 | Dec 4, 2013 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sandoz | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 078749-001 | Nov 6, 2008 | AT1 | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sandoz | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 090604-001 | Nov 18, 2009 | AT1 | RX | 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 |
