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Generated: December 16, 2018

DrugPatentWatch Database Preview

ULESFIA Drug Profile

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Which patents cover Ulesfia, and when can generic versions of Ulesfia launch?

Ulesfia is a drug marketed by Shionogi Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in ULESFIA is benzyl alcohol. There are fifty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the benzyl alcohol profile page.

Drug patent expirations by year for ULESFIA
Generic Entry Opportunity Date for ULESFIA
Generic Entry Date for ULESFIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
LOTION;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 ULESFIA
Drug ClassPediculicide
Medical Subject Heading (MeSH) Categories for ULESFIA
Synonyms for ULESFIA
.alpha.-Hydroxytoluene
.alpha.-Toluenol
(Hydroxymethyl)benzene
(Hydroxymethyl)polystyrene
(Hydroxymethyl)polystyrene, 200-400 mesh, extent of labeling: ~1.7 mmol/g loading
(Hydroxymethyl)polystyrene, 200-500 mesh, extent of labeling: ~1.1 mmol/g loading
100-51-6
1336-27-2
185532-71-2
3762963D-6C2A-4BFF-AD94-3180E51BCA68
3983-EP2269992A1
3983-EP2270004A1
3983-EP2270005A1
3983-EP2270011A1
3983-EP2270505A1
3983-EP2272516A2
3983-EP2272813A2
3983-EP2272817A1
3983-EP2272822A1
3983-EP2272825A2
3983-EP2272841A1
3983-EP2274983A1
3983-EP2275102A1
3983-EP2275401A1
3983-EP2275411A2
3983-EP2275414A1
3983-EP2275425A1
3983-EP2277565A2
3983-EP2277566A2
3983-EP2277567A1
3983-EP2277568A2
3983-EP2277569A2
3983-EP2277570A2
3983-EP2277848A1
3983-EP2277867A2
3983-EP2277876A1
3983-EP2277879A1
3983-EP2279750A1
3983-EP2280001A1
3983-EP2280003A2
3983-EP2280005A1
3983-EP2280008A2
3983-EP2280010A2
3983-EP2280012A2
3983-EP2281823A2
3983-EP2284149A1
3983-EP2284160A1
3983-EP2287155A1
3983-EP2287160A1
3983-EP2287165A2
3983-EP2287166A2
3983-EP2289884A1
3983-EP2289887A2
3983-EP2289888A2
3983-EP2289892A1
3983-EP2289894A2
3983-EP2292227A2
3983-EP2292280A1
3983-EP2292596A2
3983-EP2292611A1
3983-EP2292612A2
3983-EP2292614A1
3983-EP2292615A1
3983-EP2292620A2
3983-EP2295402A2
3983-EP2295406A1
3983-EP2295411A1
3983-EP2295412A1
3983-EP2295413A1
3983-EP2295426A1
3983-EP2295427A1
3983-EP2295437A1
3983-EP2295550A2
3983-EP2298731A1
3983-EP2298734A2
3983-EP2298735A1
3983-EP2298743A1
3983-EP2298744A2
3983-EP2298750A1
3983-EP2298755A1
3983-EP2298768A1
3983-EP2298772A1
3983-EP2298775A1
3983-EP2298783A1
3983-EP2301918A1
3983-EP2301931A1
3983-EP2301936A1
3983-EP2305243A1
3983-EP2305636A1
3983-EP2305640A2
3983-EP2305651A1
3983-EP2305673A1
3983-EP2305676A1
3983-EP2305695A2
3983-EP2305696A2
3983-EP2305697A2
3983-EP2305698A2
3983-EP2305808A1
3983-EP2308812A2
3983-EP2308828A2
3983-EP2308833A2
3983-EP2308839A1
3983-EP2308844A2
3983-EP2308845A2
3983-EP2308846A2
3983-EP2308854A1
3983-EP2308857A1
3983-EP2308858A1
3983-EP2308861A1
3983-EP2308867A2
3983-EP2308870A2
3983-EP2308872A1
3983-EP2308873A1
3983-EP2308875A1
3983-EP2308877A1
3983-EP2311806A2
3983-EP2311815A1
3983-EP2311816A1
3983-EP2311817A1
3983-EP2311823A1
3983-EP2311824A1
3983-EP2311829A1
3983-EP2311831A1
3983-EP2311834A1
3983-EP2311837A1
3983-EP2311842A2
3983-EP2314575A1
3983-EP2314584A1
3983-EP2314585A1
3983-EP2316470A2
3983-EP2316829A1
3983-EP2316831A1
3983-EP2316834A1
3983-EP2316835A1
3983-EP2316836A1
3983-EP2372017A1
3983-EP2374454A1
3983-EP2374783A1
3983-EP2374790A1
3983-EP2374792A1
3983-EP2380568A1
4-06-00-02222 (Beilstein Handbook Reference)
66072-40-0
a-Hydroxytoluene
a-Toluenol
A800221
AB01563201_01
AC1L18SY
AC1Q7C20
ACMC-1BQPG
AI3-01680
AJ-24171
AK146334
AKOS000119907
Alcohol bencilico
Alcohol bencilico [INN-Spanish]
alcoholum benzylicum
Alcoholum benzylicum [INN-Latin]
Alcool benzilico
Alcool benzilico [DCIT]
Alcool benzylique
Alcool benzylique [INN-French]
Alcoolbenzylique
alpha-hydroxytoluene
alpha-Toluenol
aplha-Hydroxytoluene
Aromatic alcohol
Aromatic primary alcohol
AS04466
B2378
BB_SC-7027
BBL011938
BC222892
BDBM16418
Bentalol
Bentanol
Benzal alcohol
Benzalalcohol
Benzalcohol
Benzencarbinol
Benzene Carbinol
benzene-methanol
Benzenecarbinol
benzenemethanol
benzenmethanol
Benzoyl alcohol
benzyl alcohol
Benzyl alcohol (JP15/NF)
Benzyl alcohol (JP17/NF/INN)
Benzyl alcohol (natural)
Benzyl alcohol [USAN:INN:JAN]
Benzyl alcohol Natural
Benzyl alcohol on polystyrene, 3.5 mmol/g
Benzyl alcohol polymer-bound
Benzyl Alcohol Reagent ACS Grade
Benzyl alcohol, >=99%, FCC, FG
Benzyl alcohol, 99% 250g
BENZYL ALCOHOL, ACS
Benzyl alcohol, ACS reagent, >=99.0%
Benzyl alcohol, analytical standard
Benzyl alcohol, anhydrous, 99.8%
Benzyl alcohol, AR, >=99.5%
Benzyl alcohol, certified reference material, TraceCERT(R)
Benzyl alcohol, European Pharmacopoeia (EP) Reference Standard
Benzyl alcohol, LR, >=99%
Benzyl alcohol, natural, >=98%, FG
Benzyl alcohol, p.a., ACS reagent, 99.0%
Benzyl alcohol, pharmaceutical secondary standard; traceable to USP and PhEur
Benzyl alcohol, PharmaGrade, USP/NF, Ph Eur, Manufactured under appropriate GMP controls for pharma or biopharmaceutical production.
Benzyl alcohol, polymer-bound
Benzyl alcohol, polymer-bound, 100-200 mesh, extent of labeling: 0.5-1.0 mmol/g loading, 1 % cross-linked
Benzyl alcohol, polymer-bound, 100-200 mesh, extent of labeling: 1.0-2.0 mmol/g loading, 1 % cross-linked with divinylbenzene
Benzyl alcohol, polymer-bound, 70-90 mesh, extent of labeling: 0.5-1.0 mmol/g loading, 1 % cross-linked with divinylbenzene
Benzyl alcohol, polymer-bound, 70-90 mesh, extent of labeling: 1.0-1.5 mmol/g loading, 1 % cross-linked
Benzyl alcohol, polymer-bound, 70-90 mesh, extent of labeling: 2.0-3.0 mmol loading, 1 % cross-linked
Benzyl alcohol, puriss. p.a., ACS reagent, >=99.0% (GC)
Benzyl alcohol, puriss., meets analytical specification of Ph.??Eur., BP, NF, 99-100.5% (GC)
Benzyl alcohol, ReagentPlus(R), >=99%
Benzyl alcohol, SAJ first grade, >=98.5%
Benzyl alcohol, SAJ special grade, >=99.0%
Benzyl alcohol, tested according to Ph.Eur.
BENZYL ALCOHOL, U.S.P./N.F.
Benzyl alcohol, United States Pharmacopeia (USP) Reference Standard
Benzyl alcohol, USP, 98.0-100.5%
Benzyl alcohol, Vetec(TM) reagent grade, 98%
Benzyl Alcohole
Benzyl alkohol
BENZYL-ALCOHOL
benzylalcohol
Benzylalkohol
benzylic alcohol
Benzylicum
BIDD:ER0248
bmse000407
Bn-OH
BnOH
BRN 0878307
C00556
C03485
C6H5CH2OH
CAS-100-51-6
Caswell No. 081F
CCG-213843
CCRIS 2081
CHEBI:17987
CHEMBL720
CTK0H6356
D00077
D05OIS
DB06770
DSSTox_CID_152
DSSTox_GSID_20152
DSSTox_RID_75404
DTXSID5020152
E1519
EINECS 202-859-9
enzylalcohol
EPA Pesticide Chemical Code 009502
Euxyl K 100
F0001-0019
FEMA No. 2137
FT-0622812
HMS3264B16
HSDB 46
HY-B0892
Hydroxymethyl polystyrene
hydroxymethylbenzene
Hydroxytoluene
I01-4406
I765
InChI=1/C7H8O/c8-6-7-4-2-1-3-5-7/h1-5,8H,6H
Itch-X
J-000153
Jsp000133
KB-200532
KSC176G5N
LKG8494WBH
LS-307
LS41488
MCULE-6011707909
Methanol benzene
Methanol, phenyl-
METHYL, HYDROXYPHENYL-
MFCD00004599
MFCD03792087
MolPort-001-783-216
Nat. Benzyl Alcohol
NCGC00091865-01
NCGC00091865-02
NCGC00091865-03
NCGC00091865-04
NCGC00254154-01
NCGC00259996-01
NCI-C06111
NSC 8044
NSC-760098
NSC-8044
NSC760098
NSC8044
OBZ
OR034579
OR214344
OR246346
PENTADEOTEROBENZYL ALCOHOL
Pharmakon1600-01502555
PhCH2OH
Phenolcarbinol
Phenyl Methanol
Phenyl-Methanol
phenylcarbinol
Phenylcarbinolum
phenylmethan-1-ol
phenylmethanol
Phenylmethyl alcohol
PINAPUR™ 9 BA-R
Polystyrene cross-linked with divinylbenzene, hydroxymethylated
Polystyrene crosslinked with divinylbenzene, hydroxymethylated
RP18893
RTR-033774
s4600
SBB058558
SC-47293
SCHEMBL147
SR-01000872610
SR-01000872610-3
ST24048908
ST51028320
STL163453
StratoSpheres(TM) PL-HMS (Hydroxymethylstyrene) resin, 50-100 mesh, extent of labeling: 2.0 mmol loading, 1 % cross-linked
StratoSpheres™ PL-HMS (Hydroxymethylstyrene) resin
Sunmorl BK 20
TB 13G
TOLUENE,ALPHA-HYDROXY
Tox21_111172
Tox21_202447
Tox21_300044
TR-033774
Ulesfia (TN)
UNII-LKG8494WBH
WLN: Q1R
WVDDGKGOMKODPV-UHFFFAOYSA-N
Z955123784
ZB015017
ZINC895302

US Patents and Regulatory Information for ULESFIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Shionogi Inc ULESFIA benzyl alcohol LOTION;TOPICAL 022129-001 Apr 9, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ 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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Paragraph IV (Patent) Challenges for ULESFIA
Drugname Dosage Strength RLD Date
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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Covington
US Department of Justice
Healthtrust
Express Scripts
Accenture
Colorcon
Cerilliant
Cantor Fitzgerald

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.