Details for New Drug Application (NDA): 207103
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NDA 207103 describes IBRANCE, which is a drug marketed by Pfizer and is included in two NDAs. It is available from two suppliers. There are six 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 are thirteen drug master file entries 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 are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.
Summary for 207103
| Tradename: | IBRANCE |
| Applicant: | Pfizer |
| Ingredient: | palbociclib |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207103
Generic Entry Date for 207103*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 207103
| Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
Suppliers and Packaging for NDA: 207103
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBRANCE | palbociclib | CAPSULE;ORAL | 207103 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0187 | 0069-0187-21 | 21 CAPSULE in 1 BOTTLE (0069-0187-21) |
| IBRANCE | palbociclib | CAPSULE;ORAL | 207103 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0188 | 0069-0188-21 | 21 CAPSULE in 1 BOTTLE (0069-0188-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 75MG | ||||
| Approval Date: | Feb 3, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 8, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 16, 2023 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 16, 2023 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | Y |
Expired US Patents for NDA 207103
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-003 | Feb 3, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-002 | Feb 3, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-001 | Feb 3, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-001 | Feb 3, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-002 | Feb 3, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-003 | Feb 3, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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