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Last Updated: February 16, 2020

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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 three NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Prograf

A generic version of PROGRAF was approved as tacrolimus by SANDOZ on August 10th, 2009.

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Drug patent expirations by year for PROGRAF
Drug Prices for PROGRAF

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Drug Sales Revenue Trends for PROGRAF

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Recent Clinical Trials for PROGRAF

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Barbara Ann Karmanos Cancer InstitutePhase 3
University of Michigan Rogel Cancer CenterPhase 3
Indiana University School of MedicinePhase 3

See all PROGRAF clinical trials

Pharmacology for PROGRAF
Synonyms for PROGRAF
(-)-FK 506
[(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(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
AKOS005145901
AM81227
Anhydrous Tacrolimus
Astagraf XL
AT-2441
Avagraf
BC205151
BDBM50030448
BDBM50079777
BRD-K35452788-001-02-1
BRD-K69608737-001-03-7
BRD-K69608737-001-10-2
BSPBio_001279
C01375
C44H69NO12
CAS-104987-11-3
CCRIS 7124
CHEBI:61049
CHEBI:93221
CHEMBL269732
CHEMBL66247
CS-1507
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
Protopy
PubChem18875
Q-201775
QJJXYPPXXYFBGM-LFZNUXCKSA-N
s5003
SBI-0052894.P002
SC-13591
SCHEMBL3088
SR-05000001879
SR-05000001879-1
SR-05000001879-2
SR-05000001879-5
Tacarolimus
tacrolimus
Tacrolimus (anhydrous)
tacrolimus (fk506)
Tacrolimus (INN)
Tacrolimus [USAN:INN]
Tacrolimus [USAN]
Tacrolimus anhydrous
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   Start Trial   Start Trial   Start Trial
Astellas PROGRAF tacrolimus FOR SUSPENSION;ORAL 210115-001 May 24, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Astellas PROGRAF tacrolimus CAPSULE;ORAL 050708-001 Apr 8, 1994 AB RX Yes No   Start Trial   Start Trial   Start Trial
Astellas PROGRAF tacrolimus CAPSULE;ORAL 050708-002 Apr 8, 1994 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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