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Details for New Drug Application (NDA): 203341
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 four 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: | 4 |
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 | Protein Kinase Inhibitors P-Glycoprotein 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) |
Paragraph IV (Patent) Challenges for 203341
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BOSULIF | TABLET;ORAL | bosutinib monohydrate | 203341 | 2018-10-25 |
| BOSULIF | TABLET;ORAL | bosutinib monohydrate | 203341 | 2016-09-06 |
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: | Sep 4, 2019 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH CHRONIC, ACCELERATED OR BLAST PHASE PHILADELPHIA CHROMOSOME-POSITIVE (PH+) CHRONIC MYELOGENOUS LEUKEMIA (CML) WITH RESISTANCE, OR INTOLERANCE TO PRIOR THERAPY | ||||||||
| 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) | ||||||||
| Regulatory Exclusivity Expiration: | Dec 19, 2020 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+CML) | ||||||||
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 | 203341-001 | Sep 4, 2012 | Start Trial | Start Trial |
| Pf Prism Cv | BOSULIF | bosutinib monohydrate | TABLET;ORAL | 203341-003 | Oct 27, 2017 | Start Trial | Start Trial |
| Pf Prism Cv | BOSULIF | bosutinib monohydrate | TABLET;ORAL | 203341-002 | Sep 4, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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