Is there a generic for Brilliant blue g?

The FDA Orange Book does not currently list an approved generic (ANDA) for Brilliant blue g. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Brilliant blue g?

TISSUEBLUE (NDA 209569, DUTCH OPHTHALMIC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Does Brilliant blue g have FDA marketing exclusivity?

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

What dosage forms of Brilliant blue g are approved?

Brilliant blue g is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Brilliant blue g

Brilliant blue g: 1 brand, 0 generics; first approved Dec 20, 2019.

Brand only1 exclusivity period

Generic status & protection

Marketing exclusivity runs through Dec 20, 2026.

Latest exclusivity ends Dec 20, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

TISSUEBLUERLDRS

DUTCH OPHTHALMICNDA 2095692019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	SOLUTION	OPHTHALMIC	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (1)

ODE-282Orphan-drug exclusivity (7 years)
Dec 20, 2026
in 6 mo

Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval

Dec 20, 2019

6 yr 8 mo ago

Most recent approval

Dec 20, 2019

6 yr 8 mo ago

All 1 application were approved in 2019.

Brand (NDA) 1100%

Generic (ANDA) 00%

Brilliant blue g — 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.

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