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Last Updated: January 18, 2020

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ASTAGRAF XL Drug Profile

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When do Astagraf Xl patents expire, and when can generic versions of Astagraf Xl launch?

Astagraf Xl is a drug marketed by Astellas and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in thirty-two countries.

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

US ANDA Litigation and Generic Entry Outlook for Astagraf Xl

  Start Trial

A generic version of ASTAGRAF XL was approved as tacrolimus by SANDOZ on January 18th, 2020.

Summary for ASTAGRAF XL
Drug patent expirations by year for ASTAGRAF XL
Recent Clinical Trials for ASTAGRAF XL

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

SponsorPhase
University of Colorado, DenverEarly Phase 1
Cedars-Sinai Medical CenterPhase 4
Astellas Pharma IncN/A

See all ASTAGRAF XL clinical trials

Pharmacology for ASTAGRAF XL
Synonyms for ASTAGRAF XL
(-)-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
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
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 ASTAGRAF XL
Tradename Dosage Ingredient NDA Submissiondate
ASTAGRAF XL CAPSULE, EXTENDED RELEASE;ORAL tacrolimus 204096 2013-09-24

US Patents and Regulatory Information for ASTAGRAF XL

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 204096-001 Jul 19, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-001 Jul 19, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 Jul 19, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-002 Jul 19, 2013 RX Yes No   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 ASTAGRAF XL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas ASTAGRAF XL tacrolimus CAPSULE, EXTENDED RELEASE;ORAL 204096-003 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 204096-001 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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McKinsey

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