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Generated: September 23, 2018

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ELIDEL Drug Profile

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

Elidel is a drug marketed by Valeant Bermuda and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in ELIDEL is pimecrolimus. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pimecrolimus profile page.

Drug patent expirations by year for ELIDEL
Generic Entry Opportunity Date for ELIDEL
Generic Entry Date for ELIDEL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CREAM;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ELIDEL
Synonyms for ELIDEL
(1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4S)-4-chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.0?,?]octacos
(1R,9S,12S,13S,14S,17R,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4S)-4-chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.0;{4,9}]octacos-
(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-3-((E)-2-((1R,3R,4S)-4-chloro-3-methoxycyclohexyl)-1-methylvinyl)-8-ethyl-5,6,8,11,12,13,14,15,16,17,18,19,24,26,26a-hexadecahydro-5,19-epoxy-3H-pyrido(2,1-c)(1,4)oxaazacyclotrico
071P320
137071-32-0
15,19-Epoxy-3H-pyrido(2,1-c)(1,4)oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, 3-((1E)-2-((1R,3R,4S)-4-chloro-3-methoxycyclohexyl)-1-methylethenyl)-8-ethyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-di
15,19-Epoxy-3H-pyrido(2,1-c)(1,4)oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, 3-(2-(4-chloro-3-methoxycyclohexyl)-1-methylethenyl)-8-ethyl-, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-14,16-
33-epi-Chloro-33-desoxyascomycin
33-Epichloro-33-desoxyascomycin
4CA-1022
7KYV510875
AB01566841_01
ABP000224
AC-5268
AK104470
AKOS015895946
AKOS025294424
AKOS025402125
AKOS030241463
AKOS032947242
AN-5319
AOB5971
ASM 981
ASM-981
ASM-998
B1817
BC622572
C43H68ClNO11
CAS-137071-32-0
CHEBI:135888
CHEMBL1200686
CHEMBL2358045
CS-2691
CTK8E7298
D05480
D0Z4UN
DB00337
DSSTox_CID_26674
DSSTox_GSID_46674
DSSTox_RID_81811
DTXSID2046674
Elidel (TN)
GTPL6783
HY-13723
I06-1252
LS-181798
MFCD00901792
MolPort-003-666-749
MolPort-008-155-973
NCGC00167506-01
Picrolimus
Pimecrolimus
Pimecrolimus (JAN/USAN/INN)
Pimecrolimus [USAN:INN:BAN]
Pimecrolimus, >=97% (HPLC)
Pimecrolimus(Elidel)
Pimecrolimus/
Pimecrolimusum
Q-201579
s5004
SCHEMBL181248
SCHEMBL26411
SCHEMBL3000675
SCHEMBL438880
SCHEMBL4651515
SDZ ASM 981
SDZ-ASM 981
SDZ-ASM-981
SR-01000942254
SR-01000942254-1
ST24048917
Tox21_112504
UNII-7KYV510875
X7261
ZINC169356261
ZINC253496134
ZINC85536990
ZINC95604109

US Patents and Regulatory Information for ELIDEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Bermuda ELIDEL pimecrolimus CREAM;TOPICAL 021302-001 Dec 13, 2001 RX Yes Yes ➤ 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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Supplementary Protection Certificates for ELIDEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
12/2003 Austria ➤ Sign Up PRODUCT NAME: PIMECROLIMUS, GEGEBENENFALLS IN FORM PHARMAZEUTISCH ANNEHMBARER SALZE
C/GB03/015 United Kingdom ➤ Sign Up PRODUCT NAME: PIMECROLIMUS OR SALTS OR ESTERS THEREOF; REGISTERED: DK 21034 (MT-NO.32700) 20020315; UK PL 00101/0659 20021003
/2003 Austria ➤ Sign Up PRODUCT NAME: PIMECROLIMUS, GEGEBENENFALLS IN FORM PHARMAZEUTISCH ANNEHMBARER SALZE; NAT. REGISTRATION NO/DATE: 1-24689 20020917; FIRST REGISTRATION: DK 21034 20020315
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
UBS
Citi
Moodys
Cantor Fitzgerald
Harvard Business School
Mallinckrodt
Medtronic
US Department of Justice

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