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 two NDAs. 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 Loss of Exclusivity (LOE) Date for 203341
Generic Entry Date for 203341*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML), NEWLY-DIAGNOSED OR RESISTANT OR INTOLERANT TO PRIOR THERAPY 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 | Bcr-Abl Tyrosine 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: | Sep 26, 2026 | ||||||||
| Regulatory Exclusivity Use: | FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML), NEWLY-DIAGNOSED OR RESISTANT OR INTOLERANT TO PRIOR THERAPY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 19, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 26, 2027 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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 | ⤷ Subscribe | ⤷ Subscribe |
| Pf Prism Cv | BOSULIF | bosutinib monohydrate | TABLET;ORAL | 203341-002 | Sep 4, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Pf Prism Cv | BOSULIF | bosutinib monohydrate | TABLET;ORAL | 203341-003 | Oct 27, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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