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Last Updated: December 14, 2019

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Tacrolimus - Generic Drug Details

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What are the generic drug sources for tacrolimus and what is the scope of patent protection?

Tacrolimus is the generic ingredient in five branded drugs marketed by Astellas, Accord Hlthcare, Belcher Pharms Llc, Dr Reddys Labs Ltd, Heritage Pharma, Mylan, Panacea Biotec Ltd, Sandoz, Strides Pharma, Hospira Inc, Leo Pharma As, Fougera Pharms Inc, Glenmark Pharms Ltd, and Veloxis Pharms Inc, and is included in eighteen NDAs. There are twenty patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tacrolimus has one hundred and twenty-seven patent family members in thirty-four countries.

There are twenty drug master file entries for tacrolimus. Twenty-five suppliers are listed for this compound.

Drug Prices for tacrolimus

See drug prices for tacrolimus

Drug Sales Revenue Trends for tacrolimus

See drug sales revenues for tacrolimus

Recent Clinical Trials for tacrolimus

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 tacrolimus clinical trials

Pharmacology for tacrolimus
Medical Subject Heading (MeSH) Categories for tacrolimus
Synonyms for tacrolimus
(-)-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
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 (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
Paragraph IV (Patent) Challenges for TACROLIMUS
Tradename Dosage Ingredient NDA Submissiondate
ASTAGRAF XL CAPSULE, EXTENDED RELEASE;ORAL tacrolimus 204096 2013-09-24
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 2010-11-22
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 2010-09-09

US Patents and Regulatory Information for tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013   Start Trial   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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