Is there a generic for Pimecrolimus?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Pimecrolimus, referencing the brand ELIDEL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Pimecrolimus?

ELIDEL (NDA 021302, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pimecrolimus are approved?

Pimecrolimus is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Pimecrolimus

Pimecrolimus is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ELIDEL · NDA 021302

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream

Product	Applicant	Application	TE	Approved
ELIDELRLD	BAUSCH	NDA 021302	AB	Dec 13, 2001

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
PIMECROLIMUS	GLENMARK PHARMS LTD	ANDA 211769	AB	Aug 29, 2019
PIMECROLIMUS	ACTAVIS LABS UT INC	ANDA 209345	AB	Dec 27, 2018

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.

Pimecrolimus — frequently asked questions

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

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