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Last Updated: November 13, 2019

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BOSULIF Drug Profile

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

Bosulif is a drug marketed by Pf Prism Cv and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has forty-four patent family members in twenty-eight countries.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bosutinib monohydrate profile page.

Drug patent expirations by year for BOSULIF
Drug Prices for BOSULIF

See drug prices for BOSULIF

Generic Entry Opportunity Date for BOSULIF
Generic Entry Date for BOSULIF*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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.

Recent Clinical Trials for BOSULIF

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alzheimer's AssociationPhase 2
Georgetown UniversityPhase 2
Georgetown UniversityPhase 1

See all BOSULIF clinical trials

Recent Litigation for BOSULIF

Identify potential future generic entrants

District Court Litigation
Case NameDate
Wyeth LLC v. Sun Pharmaceutical Industries Limited2017-09-28
Wyeth LLC v. MSN Laboratories Private Limited2017-03-07
Wyeth LLC v. Sun Pharmaceutical Industries, Inc.2016-12-23

See all BOSULIF litigation

Pharmacology for BOSULIF
Synonyms for BOSULIF
1391063-17-4
3-Quinolinecarbonitrile, 4-((2,4-dichloro-5-methoxyphenyl)amino)-6-methoxy-7-(3-(4-methyl-1-piperazinyl)propoxy)-
3-Quinolinecarbonitrile, 4-((2,4-dichloro-5-methoxyphenyl)amino)-6-methoxy-7-(3-(4-methyl-1-piperazinyl)propoxy)-, hydrate (1:1)
380843-75-4
4-((2,4-dichloro-5-methoxyphenyl)amino)-6-methoxy-7-(3-(4-methyl-1-piperazinyl)propoxy)-3-quinolinecarbonitrile
4-((2,4-dichloro-5-methoxyphenyl)amino)-6-methoxy-7-(3-(4-methylpiperazin-1-yl)propoxy)quinoline-3-carbonitrile
4-(2,4-dichloro-5-methoxy-anilino)-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile
4-(2,4-dichloro-5-methoxyanilino)-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile
4-(2,4-dichloro-5-methoxyphenylamino)-6-methoxy-7-(3-(4-methylpiperazin-1-yl)propoxy)quinoline-3-carbonitrile
4-(3,5-Dichloro-4-methoxyanilino)-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile
4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-3-quinolinecarbonitrile monohydrate
4-[(2,4-Dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile
4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile monohydrate
4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile
4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile monohydrate
4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline-3-carbonitrile--water (1/1)
5018V4AEZ0
843B754
844ZJE6I55
918639-08-4
A25014
AB0008633
AB01565836_03
ABP000235
AC-2413
AC-30573
AC1NS5P1
AKOS015902521
AKOS027326604
AN-465
AOB87309
API0024729
AS-11064
BC644818
BCP01782
BCP17036
BCP9000446
BCPP000318
BDBM4552
Bosulif (TN)
Bosulif(R)
Bosutinib
Bosutinib - SKI-606
Bosutinib (SKI-606)
Bosutinib (SKI606)
Bosutinib (USAN)
Bosutinib [USAN:INN]
bosutinib hydrate
Bosutinib hydrate (JAN)
Bosutinib monohydrate
Bosutinib, >=98% (HPLC)
Bosutinib,SKI-606
bosutinib.H2O
Bosutinib(SKI-606)
Bosutinib|380843-75-4|SKI606|SKI 606
BRD-K99964838-001-01-0
BRD-K99964838-001-06-9
BXPOSPOKHGNMEP-UHFFFAOYSA-N
CCG-208129
CHEBI:39112
CHEBI:68533
CHEMBL288441
CS-0118
D03252
D09728
DB06616
DB8
DTXSID20238722
EC 700-455-1
EX-A391
FT-0656231
GTPL5710
HMS2043A22
HMS3244A03
HMS3244A04
HMS3244B03
HMS3651C03
HY-10158
I14-1974
J-519931
K00615a
KB-75762
MFCD07367846
MLS006011212
MolPort-008-155-956
NCGC00241107-01
NCGC00241107-03
NCGC00241107-05
PB30881
PF-5208763
PubChem22404
Q-200745
Q-4427
QCR-26
RL03452
S1014
SC-23008
SCHEMBL158390
SCHEMBL2887945
SK 606
SK-606
SKI 606
SKI-606
SKI-606 monohydrate
SKI-606;4-(2,4-Dichloro-5-methoxy-phenylamino)-6-methoxy-7-[3-(4-methyl-piperazin-1-yl)-propoxy]-quinoline-3-carbonitrile
SKI606
SMR002530350
SR-01000941572
SR-01000941572-1
SW220197-1
SYN1025
UBPYILGKFZZVDX-UHFFFAOYSA-N
UNII-5018V4AEZ0
UNII-844ZJE6I55
WAY-173606
X4840
ZINC22448983
Paragraph IV (Patent) Challenges for BOSULIF
Tradename Dosage Ingredient NDA Submissiondate
BOSULIF TABLET;ORAL bosutinib monohydrate 203341 2018-10-25
BOSULIF TABLET;ORAL bosutinib monohydrate 203341 2016-09-06

US Patents and Regulatory Information for BOSULIF

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No   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 BOSULIF

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012   Start Trial   Start Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012   Start Trial   Start Trial
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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