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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Harvard Business School
Boehringer Ingelheim
Chubb
Teva
Moodys
UBS
Chinese Patent Office
Queensland Health

Generated: July 15, 2018

DrugPatentWatch Database Preview

Tacrolimus - Generic Drug Details

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

Tacrolimus
is the generic ingredient in five branded drugs marketed by Astellas, Accord Hlthcare, Belcher Pharms Llc, Dr Reddys Labs Ltd, Mylan, Panacea Biotec Ltd, Sandoz, Strides Pharma, Watson Labs, Hospira Inc, Leo Pharma As, Fougera Pharms Inc, Glenmark Pharms Ltd, and Veloxis Pharms Inc, and is included in seventeen NDAs. There are nineteen 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-five patent family members in thirty-four countries.

There are twenty drug master file entries for tacrolimus. Twenty-seven suppliers are listed for this compound.
Summary for tacrolimus
Pharmacology for tacrolimus
Medical Subject Heading (MeSH) Categories for tacrolimus
Synonyms for tacrolimus
(-)-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
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 (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 tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs TACROLIMUS tacrolimus CAPSULE;ORAL 090402-001 Jul 1, 2010 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Expired US Patents for tacrolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astellas PROGRAF tacrolimus INJECTABLE;INJECTION 050709-001 Apr 8, 1994 ➤ Sign Up ➤ Sign Up
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000 ➤ Sign Up ➤ Sign Up
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 ➤ Sign Up ➤ Sign Up
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for tacrolimus

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
2,014,038,998 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
US Army
Colorcon
QuintilesIMS
Dow
Chubb
Farmers Insurance
Baxter
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.