Is there a generic for Trypan blue?

The FDA Orange Book does not currently list an approved generic (ANDA) for Trypan blue. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Trypan blue?

MEMBRANEBLUE (NDA 022278, DORC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Trypan blue are approved?

Trypan blue is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Trypan blue

Trypan blue is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:MEMBRANEBLUE · NDA 022278

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
MEMBRANEBLUERLD	DORC	NDA 022278	—	Feb 20, 2009
VISIONBLUERLD	DORC	NDA 021670	—	Dec 16, 2004

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.

Trypan blue — frequently asked questions

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

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

Book a Demo