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 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 212436

Tradename:	IBRANCE
Applicant:	Pfizer
Ingredient:	palbociclib
Patents:	3

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:	Mar 16, 2029
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	10,723,730*PED	Patent Expiration:	Aug 8, 2034	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 212436

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019	6,936,612	⤷ Get Started Free
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-002	Nov 1, 2019	7,456,168	⤷ Get Started Free
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019	6,936,612	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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