FDA Orange Book · active-ingredient family
Brinzolamide
Brinzolamide: 1 brand, 3 generics; first approved Apr 01, 1998; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
4
Brand (NDA) products
Originator applications
- SANDOZNDA 0208161998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SUSPENSION/DROPS OPHTHALMIC Rx AB
Generic (ANDA) products (3)
Abbreviated applications
- BRINZOLAMIDEPADAGIS USANDA 2119142023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SUSPENSION/DROPS OPHTHALMIC Discontinued — - BRINZOLAMIDEBAUSCH AND LOMBANDA 2048842021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SUSPENSION/DROPS OPHTHALMIC Rx AB - BRINZOLAMIDEWATSON LABS INCANDA 2094062020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% SUSPENSION/DROPS OPHTHALMIC Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
28 yr 10 mo ago
Most recent approval
3 yr 1 mo ago
Approvals span 1998–2023 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Brinzolamide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
