DORZOLAMIDE HYDROCHLORIDE - Generic Drug Details
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What are the generic 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gland Pharma Ltd | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 215520-001 | Sep 19, 2022 | AT1 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zambon Spa | DORZOLAMIDE HYDROCHLORIDE | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 091034-001 | Dec 4, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Sub Merck | TRUSOPT | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 020408-001 | Dec 9, 1994 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Indoco | DORZOLAMIDE HYDROCHLORIDE | dorzolamide hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 202053-001 | Sep 11, 2014 | AT | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alembic | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 213099-001 | May 4, 2021 | AT1 | 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 |
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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