Is there a generic for Alitretinoin?

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

What is the reference-listed drug for Alitretinoin?

PANRETIN (NDA 020886, ADVANZ PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Alitretinoin are approved?

Alitretinoin is approved in the following dosage form: gel.

FDA Orange Book · active-ingredient family

Alitretinoin

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

Reference-listed drug:PANRETIN · NDA 020886

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · gel

Product	Applicant	Application	TE	Approved
PANRETINRLD	ADVANZ PHARMA	NDA 020886	—	Feb 02, 1999

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.

Alitretinoin — frequently asked questions

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

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