Question 1

Is there a generic for Brimonidine tartrate; carbachol?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Brimonidine tartrate; carbachol. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Brimonidine tartrate; carbachol?

Accepted Answer

YUVEZZI (NDA 220142, VISUS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Brimonidine tartrate; carbachol?

Accepted Answer

The Orange Book lists 2 patents against Brimonidine tartrate; carbachol products, with the earliest listed expiry in 2030. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Brimonidine tartrate; carbachol have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Brimonidine tartrate; carbachol. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Brimonidine tartrate; carbachol are approved?

Accepted Answer

Brimonidine tartrate; carbachol is approved in the following dosage form: solution/drops.

Patent	Expires	In	Type
8455494	May 24, 2030	in 4 yr	U-3741
12268662	Nov 10, 2042	in 16 yr 8 mo	ProductU-3741

Brimonidine tartrate; carbachol

Brand (NDA) products · solution/drops

Marketing exclusivity (1)

Listed patents (2)

Brimonidine tartrate; carbachol — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.