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Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207103

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NDA 207103 describes IBRANCE, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the IBRANCE profile page.

The generic ingredient in IBRANCE is palbociclib. There are ten 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 Inc
Ingredient:palbociclib
Patents:3
Generic Entry Opportunity 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
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:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Feb 3, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 3, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 19, 2019
Regulatory Exclusivity Use:TREATMENT OF HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION THERAPY WITH PALBOCICLIB AND FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY.
Patent:➤ Try a Free TrialPatent Expiration:Jan 22, 2023Product Flag?YSubstance Flag?YDelist Request?

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