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Last Updated: November 19, 2019

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PROTOPIC Drug Profile

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Which patents cover Protopic, and what generic alternatives are available?

Protopic is a drug marketed by Leo Pharma As and is included in one NDA.

The generic ingredient in PROTOPIC 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.

Drug patent expirations by year for PROTOPIC
Drug Prices for PROTOPIC

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Drug Sales Revenue Trends for PROTOPIC

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Recent Clinical Trials for PROTOPIC

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SponsorPhase
National Cancer Institute (NCI)Phase 1/Phase 2
M.D. Anderson Cancer CenterPhase 1/Phase 2
M.D. Anderson Cancer CenterPhase 2

See all PROTOPIC clinical trials

Pharmacology for PROTOPIC
Synonyms for PROTOPIC
(-)-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
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 PROTOPIC
Tradename Dosage Ingredient NDA Submissiondate
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 2010-11-22
PROTOPIC OINTMENT;TOPICAL tacrolimus 050777 2010-09-09

US Patents and Regulatory Information for PROTOPIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000 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

Expired US Patents for PROTOPIC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000   Start Trial   Start Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000   Start Trial   Start Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-002 Dec 8, 2000   Start Trial   Start Trial
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000   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:

Baxter
Dow
Medtronic
Johnson and Johnson
Mallinckrodt
Harvard Business School

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