Is there a generic for Clocortolone pivalate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Clocortolone pivalate, referencing the brand CLODERM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Clocortolone pivalate?

CLODERM (NDA 017765, LEGACY PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Clocortolone pivalate are approved?

Clocortolone pivalate is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Clocortolone pivalate

Clocortolone pivalate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CLODERM · NDA 017765

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream

Product	Applicant	Application	TE	Approved
CLODERMRLD	LEGACY PHARMA	NDA 017765	AB	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
CLOCORTOLONE PIVALATE	TARO	ANDA 206370	AB	Apr 21, 2020

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.

Clocortolone pivalate — frequently asked questions

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

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