Is Tissueblue still available?

Yes. Tissueblue (NDA 209569) is listed with marketing status Prescription in the FDA Orange Book.

Does Tissueblue have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Tissueblue's active ingredient (Brilliant Blue G).

Does Tissueblue have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Tissueblue. Exclusivity can delay generic approval independently of any listed patents.

What is Tissueblue's FDA application number?

Tissueblue is approved under NDA 209569, held by Dutch Ophthalmic.

Orange Book product · Brand (NDA)

Tissueblue

Brilliant Blue G

Brand (NDA)NDA 209569RLD Dutch Ophthalmic

Approved

Dec 20, 2019

Application

Brand (NDA)

TE code

Not listed

Listed patents

Tissueblue (Brilliant Blue G) is Dutch Ophthalmic's brand-name drug, approved by the FDA under NDA 209569 in 2019. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. 1 marketing-exclusivity period is recorded.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Dec 20, 2019
6 yr 8 mo ago
Today
Exclusivity ends · ODE-282
Orphan-drug exclusivity (7 years)
Dec 20, 2026
in 6 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

BRILLIANT BLUE G

Strength

0.025%

Dosage form

SOLUTION

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 209569

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Brilliant Blue G family

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.

Tissueblue — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Brilliant Blue G active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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