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Last Updated: December 2, 2022

Bosutinib monohydrate - Generic Drug Details


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What are the generic sources for bosutinib monohydrate and what is the scope of patent protection?

Bosutinib monohydrate is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bosutinib monohydrate has eighty-four patent family members in thirty-two countries.

There is one drug master file entry for bosutinib monohydrate. Two suppliers are listed for this compound.

Summary for bosutinib monohydrate
Recent Clinical Trials for bosutinib monohydrate

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

SponsorPhase
City of Hope Medical CenterPhase 1
National Cancer Institute (NCI)Phase 1

See all bosutinib monohydrate clinical trials

Paragraph IV (Patent) Challenges for BOSUTINIB MONOHYDRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BOSULIF Tablets bosutinib monohydrate 400 mg 203341 1 2018-10-25
BOSULIF Tablets bosutinib monohydrate 100 mg and 500 mg 203341 2 2016-09-06

US Patents and Regulatory Information for bosutinib monohydrate

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 203341-003 Oct 27, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-001 Sep 4, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-003 Oct 27, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pf Prism Cv BOSULIF bosutinib monohydrate TABLET;ORAL 203341-002 Sep 4, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 bosutinib monohydrate

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

International Patents for bosutinib monohydrate

Country Patent Number Title Estimated Expiration
European Patent Office 1680119 4-ANILINO-3-QUINOLINECARBONITRILES DESTINES AU TRAITEMENT DE LA LEUCEMIE MYELOIDE CHRONIQUE (LMC) (4-ANILINO-3-QUINOLINECARBONITRILES FOR THE TREATMENT OF CHRONIC MYELOGENOUS LEUKEMIA (CML)) See Plans and Pricing
China 101686973 Treatment of imatinib resistant leukemia using 4-aminoquinoline-3-carbonitriles See Plans and Pricing
Costa Rica 9596 FORMAS CRISTALINAS DE 4-[(2,4-DICLORO-5-METOXIFENIL)AMINO]-6-METOXI-7-[3-(4-METIL-1-PIPERAZINIL)PROPOXI]-3-QUINOLINOCARBONITRILO Y METODOS PARA SU PREPARACION See Plans and Pricing
Denmark 2478905 See Plans and Pricing
China 101248047 Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same See Plans and Pricing
Ecuador SP066548 4-ANILINO-3-QUINOLINCARBONITRILOS PARA EL TRATAMIENTO DE LEUCEMIA MIELOGENA CRONICA See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Baxter
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Boehringer Ingelheim
Johnson and Johnson

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