Generic for Prograf: Tacrolimus

Yes. The generic name for Prograf is tacrolimus. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP, BX. Generics match 4 of the 6 Prograf products the Orange Book lists.

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Prograf products in the Orange Book

Prograf products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	EQ 0.5MG BASE	Marketed (Rx)	AB	11	AB, BX
capsule, oral	EQ 1MG BASE	Marketed (Rx)	AB	11	AB, BX
capsule, oral	EQ 5MG BASE	Marketed (Rx)	AB	11	AB, BX
for suspension, oral	EQ 0.2MG BASE/PACKET	Marketed (Rx)	None	0	None
for suspension, oral	EQ 1MG BASE/PACKET	Marketed (Rx)	None	0	None
injectable, injection	EQ 5MG BASE/ML	Marketed (Rx)	AP	1	AP

NDA 050708, 210115, 050709, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic tacrolimus

Approved generic versions of Prograf
Company	ANDA	TE code	Approved	Strengths
SANDOZ INC	065461	AB (A-rated, therapeutically equivalent)	August 10, 2009	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE
DR REDDYS LABORATORIES LTD	090509	AB (A-rated, therapeutically equivalent)	May 12, 2010	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE
MYLAN PHARMACEUTICALS INC	090596	AB (A-rated, therapeutically equivalent)	September 17, 2010	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE
ACCORD HEALTHCARE INC	091195	BX (B-rated, not considered equivalent)	August 31, 2011	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE
PANACEA BIOTEC PHARMA LTD	090802	AB (A-rated, therapeutically equivalent)	September 28, 2012	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE
STRIDES PHARMA GLOBAL PTE LTD	090687	AB (A-rated, therapeutically equivalent)	July 22, 2014	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE
AJENAT PHARMACEUTICALS LLC	206651	AB (A-rated, therapeutically equivalent)	November 30, 2017	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE
BIOCON PHARMA LTD	212297	AB (A-rated, therapeutically equivalent)	November 10, 2020	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE
CONCORD BIOTECH LTD	213112	AB (A-rated, therapeutically equivalent)	November 10, 2020	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE
GLENMARK PHARMACEUTICALS LTD	206662	AB (A-rated, therapeutically equivalent)	November 10, 2020	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE
ALKEM LABORATORIES LTD	203740	AB (A-rated, therapeutically equivalent)	November 12, 2020	EQ 0.5MG BASE, EQ 1MG BASE, EQ 5MG BASE
NEXUS PHARMACEUTICALS LLC	217108	AP (A-rated, therapeutically equivalent)	February 12, 2025	EQ 5MG BASE/ML

Prograf exclusivity

Exclusivity listed for Prograf
Code	Meaning	Expires	NDA
ODE-360	Orphan drug exclusivity	July 16, 2028	050708

Prograf NDC codes

Questions

Is there a generic for Prograf?

Yes. The generic name for Prograf is tacrolimus. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP, BX. Generics match 4 of the 6 Prograf products the Orange Book lists.

What is the generic name for Prograf?

The active ingredient in Prograf is tacrolimus, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

Generic for Prograf