Is there a generic for Porfimer sodium?

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

What is the reference-listed drug for Porfimer sodium?

PHOTOFRIN (NDA 020451, PINNACLE BIOLGS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Porfimer sodium are approved?

Porfimer sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Porfimer sodium

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

Reference-listed drug:PHOTOFRIN · NDA 020451

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
PHOTOFRIN	PINNACLE BIOLGS	NDA 020451	—	Dec 27, 1995

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.

Porfimer sodium — frequently asked questions

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

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