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FDA Orange Book · active-ingredient family

Brimonidine tartrate; brinzolamide

Brimonidine tartrate; brinzolamide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SIMBRINZA · NDA 204251

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · suspension/drops

ProductApplicantApplicationTEApproved
SIMBRINZARLDALCON LABS INCNDA 204251Apr 19, 2013

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9421265Jun 17, 2030in 4 yr 1 mo
Product
9044484Oct 30, 2030in 4 yr 5 mo
Product

Brimonidine tartrate; brinzolamide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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