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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
US Department of Justice
Mallinckrodt
Fuji
Deloitte
Cerilliant
Daiichi Sankyo
AstraZeneca
Merck

Generated: December 16, 2018

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XENICAL Drug Profile

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When do Xenical patents expire, and what generic alternatives are available?

Xenical is a drug marketed by Cheplapharm and is included in one NDA. There is one patent protecting this drug.

This drug has forty patent family members in thirty-three countries.

The generic ingredient in XENICAL is orlistat. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the orlistat profile page.

Drug patent expirations by year for XENICAL
Pharmacology for XENICAL
Synonyms for XENICAL
(-)-tetrahydrolipostatin
(-)-Tetrahydrolipstatin
(-)-Tetrahydrolipstatin; N-Formyl-L-leucine (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl] dodecyl ester; Ro-18-0647
(2S)-1-[(2S,3S)-3-hexyl-4-oxooxetan-2-yl]tridecan-2-yl (2S)-2-formamido-4-methylpentanoate
(2S)-1-[(2S,3S)-3-hexyl-4-oxooxetan-2-yl]tridecan-2-yl N-formyl-L-leucinate
(2S)-2-formamido-4-methylpentanoic acid [(2S)-1-[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]tridecan-2-yl] ester
(S)-1-((2S,3S)-3-hexyl-4-oxooxetan-2-yl)tridecan-2-yl formyl-L-leucinate
[(1S)-1-[[(2S,3S)-3-hexyl-4-oxo-oxetan-2-yl]methyl]dodecyl] (2S)-2-formamido-4-methyl-pentanoate
[(2S)-1-[(2S,3S)-3-hexyl-4-oxooxetan-2-yl]tridecan-2-yl] (2S)-2-formamido-4-methylpentanoate
1-((3-hexyl-4-oxo-2-oxetanyl)methyl)dodecyl-2-formamido-4-methylvalerate
111397-16-1
2-formamido-3-[(3-hexyl-4-oxo-oxetan-2-yl)methyl]-2-isobutyl-tetradecanoate
829O582
95M8R751W8
96829-58-2
AB00639987_10
AB00639987-09
AB1009256
AC1MHWQP
AHLBNYSZXLDEJQ-FWEHEUNISA-N
AKOS015894875
Alli
Alli (TN)
Alli, Xenical, Tetrahydrolipstatin, Orlistat
AN-15658
AOB6737
BC214880
BCP0726000044
BCP9001031
BDBM24567
BIDD:GT0853
C29H53NO5
CCG-100851
CHEBI:94686
CHEMBL175247
CPD000466339
CS-2165
D04028
D0T9TJ
DB01083
DR003050
DTXSID8023395
FT-0082584
FT-0601570
GlaxoSmithKline brand of orlistat
GTPL5277
HMS2051I08
Hoffmann-La Roche brand of orlistat
HY-B0218
J90006
KS-1183
L-Leucine, N-formyl-, (1S)-1-(((2S,3S)-3-hexyl-4-oxo-2-oxetanyl)methyl)dodecyl ester
L-Leucine, N-formyl-, (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]dodecyl ester
L-Leucine, N-formyl-, 1-((3-hexyl-4-oxo-2-oxetanyl)methyl)dodecyl ester, (2S-(2alpha(R*),3beta))-
L-Leucine,N-formyl-, (1S)-1-(((2S,3S)-3-hexyl-4-oxo-2-oxetanyl)methyl)dodecyl ester
LEU002
LP067521
LS-178328
MFCD05662360
MLS000759448
MLS001423955
MLS002207022
MolPort-005-938-035
N-Formyl-L-leucine (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]dodecyl ester
N-formyl-L-leucine (1S)-1-{[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl}dodecyl ester
N-formyl-L-leucine (S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]dodecyl ester
N-formyl-L-leucine-(S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]-dodecyl ester
N-Formyl-L-leucine, ester with (3S,4S)-3-hexyl-4-((2S)-2-hydroxytridecyl)-2-oxetanone
NC00101
NCGC00165856-01
NCGC00165856-02
O0381
Orlipastat
Orlipastatum
Orlipastatum [INN-Latin]
orlistat
Orlistat (Alli, Xenical)
Orlistat (JAN/USAN/INN)
Orlistat (USAN/INN)
Orlistat [USAN:INN]
Orlistat, >=98%, solid
Orlistat, pharmaceutical secondary standard; traceable to USP
Orlistat, United States Pharmacopeia (USP) Reference Standard
Orlistat,Tetrahydolipstat
orlistatum
PubChem18271
Q-201519
R-212
RL06088
Ro 18-0647/002
Ro 18-0647/008
Ro-18-0647
Ro-18-0647/002
Ro-180647-002
Ro-180647002
Roche brand of orlistat
s1629
SAM001246637
SC-16265
SCHEMBL16408
SMR000466339
SR-01000759417
SR-01000759417-7
ST24048848
tetrahydrolipastatin
Tetrahydrolipstatin
Tetrahydrolipstatin|||Ro 18-0647/002
THL
THLP
UNII-95M8R751W8
Xenical (TN)
Z2379810072
ZINC8214635
ZLA0015
zlchem 13

US Patents and Regulatory Information for XENICAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cheplapharm XENICAL orlistat CAPSULE;ORAL 020766-001 Apr 23, 1999 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 XENICAL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0042 Belgium ➤ Sign Up PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
C/GB98/044 United Kingdom ➤ Sign Up PRODUCT NAME: ORLISTAT; REGISTERED: UK EU/1/98/071/001 19980729; UK EU/1/98/071/002 19980729; UK EU/1/98/071/003 19980729; UK EO/1/98/071/004 19980729; UK EU/1/98/071/005 19980729; UK EU/1/98/071/006 19980729
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
US Department of Justice
Mallinckrodt
Fuji
Deloitte
Cerilliant
Daiichi Sankyo
AstraZeneca
Merck

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