Details for New Drug Application (NDA): 203341
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NDA 203341 describes BOSULIF, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the BOSULIF profile page.
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.
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.
Summary for 203341
| Tradename: | BOSULIF |
| Applicant: | Pf Prism Cv |
| Ingredient: | bosutinib monohydrate |
| Patents: | 5 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 203341
Generic Entry Date for 203341*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 203341
| Mechanism of Action | P-Glycoprotein Inhibitors Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 203341
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BOSULIF | bosutinib monohydrate | TABLET;ORAL | 203341 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0135 | 0069-0135-01 | 120 TABLET, FILM COATED in 1 BOTTLE (0069-0135-01) |
| BOSULIF | bosutinib monohydrate | TABLET;ORAL | 203341 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0136 | 0069-0136-01 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-0136-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Sep 4, 2012 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 19, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML) | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Feb 28, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR TREATING A BCRABL POSITIVE LEUKEMIA IN A SUBJECT THAT IS RESISTANT TO IMATINIB COMPRISING ADMINISTERING TO THE SUBJECT A THERAPEUTICALLY EFFECTIVE AMOUNT OF BOSUTINIB, WHEREIN THE SUBJECT HAS A MUTATION IN THE BCRABL PROTEIN AT 949T>C | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Feb 28, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR TREATING A BCRABL POSITIVE LEUKEMIA IN A SUBJECT THAT IS RESISTANT TO IMATINIB COMPRISING ADMINISTERING TO THE SUBJECT A THERAPEUTICALLY EFFECTIVE AMOUNT OF BOSUTINIB, WHEREIN THE SUBJECT HAS A MUTATION IN THE BCRABL PROTEIN AT F317L | ||||||||
Expired US Patents for NDA 203341
| 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 |
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