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Dorzolamide hydrochloride; timolol maleate - Generic Drug Details
What are the generic drug sources for dorzolamide hydrochloride; timolol maleate and what is the scope of patent protection?
Dorzolamide hydrochloride; timolol maleate
is the generic ingredient in three branded drugs marketed by Akorn, Aurobindo Pharma Ltd, Bausch And Lomb, Fdc Ltd, Indoco, Lannett Co Inc, Micro Labs, Rubicon, Sandoz, Sandoz Inc, Somerset, Teva Pharms, and Zambon Spa, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for dorzolamide hydrochloride; timolol maleate. Thirteen suppliers are listed for this compound.
Summary for dorzolamide hydrochloride; timolol maleate
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 13 |
| NDAs: | 16 |
| Drug Master File Entries: | 15 |
| Finished Product Suppliers / Packagers: | 13 |
| Clinical Trials: | 9 |
| DailyMed Link: | dorzolamide hydrochloride; timolol maleate at DailyMed |
Recent Clinical Trials for dorzolamide hydrochloride; timolol maleate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Florida | Phase 1 |
| Allergan | Phase 3 |
| Allergan | Phase 4 |
See all dorzolamide hydrochloride; timolol maleate clinical trials
Pharmacology for dorzolamide hydrochloride; timolol maleate
| Drug Class | Carbonic Anhydrase Inhibitor beta-Adrenergic Blocker |
| Mechanism of Action | Carbonic Anhydrase Inhibitors Adrenergic beta-Antagonists |
ATC Classes for dorzolamide hydrochloride; timolol maleate
Paragraph IV (Patent) Challenges for DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| COSOPT | SOLUTION/DROPS;OPHTHALMIC | dorzolamide hydrochloride; timolol maleate | 020869 | 2005-10-11 |
US Patents and Regulatory Information for dorzolamide hydrochloride; timolol maleate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fdc Ltd | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 205295-001 | Jun 13, 2019 | AT | RX | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Akorn | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 077847-001 | Oct 28, 2008 | AT | RX | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Akorn | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | AT | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| Zambon Spa | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 091180-001 | Dec 4, 2013 | DISCN | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Bausch And Lomb | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 090037-001 | Jul 14, 2009 | AT | RX | No | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | |||
| >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; timolol maleate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Akorn | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | Try Before You Buy | Try Before You Buy |
| Akorn | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | Try Before You Buy | Try Before You Buy |
| Akorn | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | Try Before You Buy | Try Before You Buy |
| Akorn | COSOPT | dorzolamide hydrochloride; timolol maleate | SOLUTION/DROPS;OPHTHALMIC | 020869-001 | Apr 7, 1998 | Try Before You Buy | Try Before You Buy |
| >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.
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