Brinzolamide - Generic Drug Details
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What are the generic sources for brinzolamide and what is the scope of patent protection?
Brinzolamide
is the generic ingredient in two branded drugs marketed by Sandoz, Bausch And Lomb, Padagis Us, and Watson Labs Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for brinzolamide. Seven suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for brinzolamide
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 96 |
Clinical Trials: | 54 |
Patent Applications: | 5,037 |
Drug Prices: | Drug price trends for brinzolamide |
What excipients (inactive ingredients) are in brinzolamide? | brinzolamide excipients list |
DailyMed Link: | brinzolamide at DailyMed |
Recent Clinical Trials for brinzolamide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sun Pharmaceutical Industries Limited | Phase 3 |
Peking University | N/A |
General Hospital of Athens Elpis | N/A |
Generic filers with tentative approvals for BRINZOLAMIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Subscribe | ⤷ Subscribe | 0.2MG,10MG | SUSPENSION/DROPS;OPHTHALMIC |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for brinzolamide
Drug Class | Carbonic Anhydrase Inhibitor |
Mechanism of Action | Carbonic Anhydrase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for brinzolamide
US Patents and Regulatory Information for brinzolamide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bausch And Lomb | BRINZOLAMIDE | brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 204884-001 | Aug 18, 2021 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Watson Labs Inc | BRINZOLAMIDE | brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 209406-001 | Nov 27, 2020 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Sandoz | AZOPT | brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 020816-001 | Apr 1, 1998 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Padagis Us | BRINZOLAMIDE | brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 211914-001 | Jul 28, 2023 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>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 brinzolamide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | AZOPT | brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 020816-001 | Apr 1, 1998 | ⤷ Subscribe | ⤷ Subscribe |
Sandoz | AZOPT | brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 020816-001 | Apr 1, 1998 | ⤷ Subscribe | ⤷ Subscribe |
Sandoz | AZOPT | brinzolamide | SUSPENSION/DROPS;OPHTHALMIC | 020816-001 | Apr 1, 1998 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for brinzolamide
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Novartis Europharm Limited | Azopt | brinzolamide | EMEA/H/C/000267 Azopt is indicated to decrease elevated intraocular pressure in:ocular hypertension;open-angle glaucomaas monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues. |
Authorised | no | no | no | 2000-03-09 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
Brinzolamide Market Analysis and Financial Projection Experimental
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