Is there a generic for Methyl aminolevulinate hydrochloride?

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

What is the reference-listed drug for Methyl aminolevulinate hydrochloride?

METVIXIA (NDA 021415, GALDERMA LABS LP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Methyl aminolevulinate hydrochloride are approved?

Methyl aminolevulinate hydrochloride is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Methyl aminolevulinate hydrochloride

Methyl aminolevulinate hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:METVIXIA · NDA 021415

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream

Product	Applicant	Application	TE	Approved
METVIXIA	GALDERMA LABS LP	NDA 021415	—	Jul 27, 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.

Methyl aminolevulinate hydrochloride — 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