Dorzolamide hydrochloride - Generic Drug Details
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What are the generic drug sources for dorzolamide hydrochloride and what is the scope of patent protection?
Dorzolamide hydrochloride
is the generic ingredient in five branded drugs marketed by Alembic, Am Regent, Bausch And Lomb, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Micro Labs, Rubicon, Sandoz, Teva Pharms, Zambon Spa, Msd Sub Merck, Thea Pharma, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Ingenus Pharms Llc, and Somerset, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.There are fourteen drug master file entries for dorzolamide hydrochloride. Twelve suppliers are listed for this compound.
Summary for dorzolamide hydrochloride
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 19 |
NDAs: | 35 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 92 |
Clinical Trials: | 56 |
Patent Applications: | 587 |
What excipients (inactive ingredients) are in dorzolamide hydrochloride? | dorzolamide hydrochloride excipients list |
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
Expired US Patents for dorzolamide hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Msd Sub Merck | TRUSOPT | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020408-001 | Dec 9, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Msd Sub Merck | TRUSOPT | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020408-001 | Dec 9, 1994 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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