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Last Updated: March 28, 2024

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
Drug Prices for brinzolamide

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Recent Clinical Trials for brinzolamide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sun Pharmaceutical Industries LimitedPhase 3
Peking UniversityN/A
General Hospital of Athens ElpisN/A

See all brinzolamide clinical trials

Generic filers with tentative approvals for BRINZOLAMIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.2MG,10MGSUSPENSION/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

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
Padagis Us BRINZOLAMIDE brinzolamide SUSPENSION/DROPS;OPHTHALMIC 211914-001 Jul 28, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb BRINZOLAMIDE brinzolamide SUSPENSION/DROPS;OPHTHALMIC 204884-001 Aug 18, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Inc BRINZOLAMIDE brinzolamide SUSPENSION/DROPS;OPHTHALMIC 209406-001 Nov 27, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz AZOPT brinzolamide SUSPENSION/DROPS;OPHTHALMIC 020816-001 Apr 1, 1998 AB RX Yes Yes ⤷  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

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 ⤷  Try a Trial ⤷  Try a Trial
Sandoz AZOPT brinzolamide SUSPENSION/DROPS;OPHTHALMIC 020816-001 Apr 1, 1998 ⤷  Try a Trial ⤷  Try a Trial
Sandoz AZOPT brinzolamide SUSPENSION/DROPS;OPHTHALMIC 020816-001 Apr 1, 1998 ⤷  Try a Trial ⤷  Try a Trial
>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

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