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PROGRAF Drug Profile

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Which patents cover Prograf, and when can generic versions of Prograf launch?

Prograf is a drug marketed by Astellas and is included in two NDAs.

The generic ingredient in PROGRAF is tacrolimus. There are twenty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the tacrolimus profile page.

Summary for PROGRAF

US Patents:	0
Applicants:	1
NDAs:	2
Suppliers / Packagers:	4
Bulk Api Vendors:	54
Clinical Trials:	162
Patent Applications:	4,730
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	PROGRAF at DailyMed

Pharmacology for PROGRAF

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors

Medical Subject Heading (MeSH) Categories for PROGRAF

Calcineurin Inhibitors

Immunosuppressive Agents

Synonyms for PROGRAF

(-)-FK 506

(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-5,19-dihydroxy-3-{(1E)-1-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl}-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(prop-2-en-1-yl)-5,6,8,11,12,13,14,15,16,17,18,19,24,25

(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-Hexadecahydro-5,19-dihydroxy-3-[(1E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetrame

[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-14,16-

104987-11-3

109581-93-3 (Hydrate)

15,19-Epoxy-3H-pyrido(2,1-c)(1,4)oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-(2-(4-hydroxy-3-methoxycyclohexyl)-14,16-dimethoxy-4,10,12,18-tetra

15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(23H)-tetrone

15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(23H)-tetrone,

15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(1E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyc

4,5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-heptadecahydro-5,19-dihydroxy-3-

581T933

8-DEETHYL-8-[BUT-3-ENYL]-ASCOMYCIN

AB0012538

AB01209746_03

AB01209746-01

ABP000474

AC-1182

AC1L9IBU

Advagraf

Advagraf (TN)

AKOS005145901

AM81227

Ambap104987-11-3

Anhydrous Tacrolimus

Astagraf XL

AT-2441

Avagraf

BC205151

BDBM50030448

BRD-K35452788-001-02-1

BSPBio_001279

BT001093

C01375

C44H69NO12

CA006303

CAS-104987-11-3

CCRIS 7124

CHEBI:61049

CHEBI:93221

CHEMBL269732

CS-1507

D06OMK

D08556

DB00864

dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-,(3S,4R,5S,8R,12S,14S,15R,16S,18R,19R,26aS)-

DSSTox_CID_26354

DSSTox_GSID_46354

DSSTox_RID_81557

DTXSID5046354

EN300-221601

Envarsus

Envarsus XR

EX-A1677

FK 506

Fk-506

FK-506 (Tacrolimus)

FK-506/Tacrolimus

FK5

FK506

FR 900506

FR-900506

FR900506

FT-0082660

Fujimycin

Fujimycin|||FK-506|||FR-900506

Graceptor

GTPL6784

Hecoria

HMS1792O21

HMS1990O21

HMS2093M19

HMS3403O21

HMS503O21

HSDB 8195

HY-13756

IDI1_001040

K506

L 679934

L-679934

LCP-Tacro

LMPK04000003

lohexyl]-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propen-1-yl)-, (3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-

M2258

MFCD11045918

Modigraf

MolPort-003-666-518

NCGC00163470-01

NCGC00163470-02

NCGC00163470-03

NCGC00163470-04

NCGC00163470-05

NCGC00163470-06

NCGC00163470-07

NSC-758659

NSC758659

Pharmakon1600-01503968

Prograf (TN)

Prograft

Protopic

Protopic (TN)

Protopy

PubChem18875

Q-201775

QJJXYPPXXYFBGM-LFZNUXCKSA-N

s5003

SBI-0052894.P002

SC-13591

SCHEMBL3088

SR-05000001879

SR-05000001879-5

Tacarolimus

tacrolimus

Tacrolimus (anhydrous)

tacrolimus (fk506)

Tacrolimus (INN)

Tacrolimus (Prograf)

Tacrolimus [USAN:INN]

Tacrolimus [USAN]

Tacrolimus anhydrous

Tacrolimus hydrate

Tacrolimus solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material

Tacrolimus, anhydrous

Talymus

Tox21_112056

Tsukubaenolide

UNII-Y5L2157C4J

W-1246

Y5L2157C4J

ZINC169289411

US Patents and Regulatory Information for PROGRAF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708-003	Aug 24, 1998	AB	RX	Yes	No
Astellas	PROGRAF	tacrolimus	INJECTABLE;INJECTION	050709-001	Apr 8, 1994	AP	RX	Yes	Yes
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708-001	Apr 8, 1994	AB	RX	Yes	No
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708-002	Apr 8, 1994	AB	RX	Yes	Yes

Expired US Patents for PROGRAF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	PROGRAF	tacrolimus	INJECTABLE;INJECTION	050709-001	Apr 8, 1994