Question 1

Is there a generic for Tacrolimus?

Accepted Answer

Yes. The FDA Orange Book lists 20 approved generic (ANDA) applications for Tacrolimus, referencing the brand PROGRAF. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Tacrolimus?

Accepted Answer

PROGRAF (NDA 210115, ASTELLAS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Tacrolimus?

Accepted Answer

The Orange Book lists 10 patents against Tacrolimus products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Tacrolimus have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 6 marketing-exclusivity periods for Tacrolimus. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Tacrolimus are approved?

Accepted Answer

Tacrolimus is approved in the following dosage forms: capsule, capsule, extended release, for suspension, injectable, ointment, tablet, extended release.

Product	Applicant	Application	TE	Approved
PROGRAFRLD×2	ASTELLAS	NDA 210115	—	May 24, 2018
ENVARSUS XRRLD×3	VELOXIS PHARMS INC	NDA 206406	—	Jul 10, 2015
ASTAGRAF XLRLD×3	ASTELLAS	NDA 204096	AB	Jul 19, 2013
PROTOPICRLD×2	LEO PHARMA AS	NDA 050777	AB	Dec 08, 2000
PROGRAFRLD×3	ASTELLAS	NDA 050708	AB	Aug 24, 1998
PROGRAFRLD	ASTELLAS	NDA 050709	AP	Apr 08, 1994

Product	Applicant	Application	TE	Approved
TACROLIMUS	NEXUS	ANDA 217108	AP	Feb 12, 2025
TACROLIMUS×3	CHENGDU	ANDA 215012	AB	Jan 25, 2024
TACROLIMUS	ENCUBE	ANDA 212387	BX	Oct 10, 2023
TACROLIMUS×2	GLENMARK PHARMS LTD	ANDA 210393	AB	Aug 16, 2023
TACROLIMUS×3	HANGZHOU ZHONGMEI	ANDA 210929	—	Apr 17, 2023
TACROLIMUS×3	ALKEM LABS LTD	ANDA 203740	AB	Nov 12, 2020
TACROLIMUS×3	BIOCON PHARMA	ANDA 212297	AB	Nov 10, 2020
TACROLIMUS×3	CONCORD BIOTECH LTD	ANDA 213112	AB	Nov 10, 2020
TACROLIMUS×3	GLENMARK PHARMS LTD	ANDA 206662	AB	Nov 10, 2020
TACROLIMUS×2	ACCORD HLTHCARE	ANDA 211688	AB	Jan 31, 2019
TACROLIMUS×3	AJENAT PHARMS	ANDA 206651	AB	Nov 30, 2017
TACROLIMUS	HOSPIRA	ANDA 203900	—	Aug 25, 2017
TACROLIMUS×2	FOUGERA PHARMS INC	ANDA 200744	AB	Sep 09, 2014
TACROLIMUS×3	STRIDES PHARMA	ANDA 090687	AB	Jul 22, 2014
TACROLIMUS×3	PANACEA	ANDA 090802	AB	Sep 28, 2012
TACROLIMUS×3	ACCORD HLTHCARE	ANDA 091195	BX	Aug 31, 2011
TACROLIMUS×3	MYLAN	ANDA 090596	AB	Sep 17, 2010
TACROLIMUS	HERITAGE PHARMA AVET	ANDA 090402	—	Jul 01, 2010
TACROLIMUS×3	DR REDDYS LABS LTD	ANDA 090509	AB	May 12, 2010
TACROLIMUS×3	SANDOZ	ANDA 065461	AB	Aug 10, 2009

Patent	Expires	In	Type
11123331	May 30, 2028	in 2 yr	U-2677
11110081	May 30, 2028	in 2 yr	U-2678
12083103	May 30, 2028	in 2 yr	U-2678
10864199	May 30, 2028	in 2 yr	U-2678
10166190	May 30, 2028	in 2 yr	Product
9549918	May 30, 2028	in 2 yr	Product
11419823	May 30, 2028	in 2 yr	Product
12403095	May 30, 2028	in 2 yr	Product
8664239	Aug 30, 2028	in 2 yr 3 mo	U-1752
8685998	Aug 30, 2028	in 2 yr 3 mo	ProductU-1752

Tacrolimus

Brand (NDA) products · capsule, capsule, extended release, for suspension, injectable, ointment, tablet, extended release

Generic (ANDA) products (20)

Marketing exclusivity (6)

Listed patents (10)

Tacrolimus — frequently asked questions

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