Details for New Drug Application (NDA): 212436
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NDA 212436 describes IBRANCE, which is a drug marketed by Pfizer and is included in two NDAs. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the IBRANCE profile page.
The generic ingredient in IBRANCE is palbociclib. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.
The generic ingredient in IBRANCE is palbociclib. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.
Summary for 212436
| Tradename: | IBRANCE |
| Applicant: | Pfizer |
| Ingredient: | palbociclib |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212436
Generic Entry Date for 212436*:
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: 212436
| Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
Suppliers and Packaging for NDA: 212436
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBRANCE | palbociclib | TABLET;ORAL | 212436 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0284 | 0069-0284-03 | 3 DOSE PACK in 1 CARTON (0069-0284-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0284-07) |
| IBRANCE | palbociclib | TABLET;ORAL | 212436 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0486 | 0069-0486-03 | 3 DOSE PACK in 1 CARTON (0069-0486-03) / 7 TABLET, FILM COATED in 1 DOSE PACK (0069-0486-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
| Approval Date: | Nov 1, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
| Regulatory Exclusivity Expiration: | Jun 24, 2029 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH TRASTUZUMAB, WITH OR WITHOUT PERTUZUMAB, AND ENDOCRINETHERAPY FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER FOLLOWING INDUCTION TREATMENT | ||||||||
| Regulatory Exclusivity Expiration: | Mar 16, 2029 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Expired US Patents for NDA 212436
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-001 | Nov 1, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-001 | Nov 1, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-003 | Nov 1, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-003 | Nov 1, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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