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Last Updated: May 6, 2021

DrugPatentWatch Database Preview

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 three suppliers. There are five 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. Three 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:4
DrugPatentWatch® Estimated Generic Entry Opportunity 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
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)
Paragraph IV (Patent) Challenges for 212436
Tradename Dosage Ingredient NDA Submissiondate
IBRANCE TABLET;ORAL palbociclib 212436 2020-11-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Nov 1, 2019TE:RLD:Yes
Patent:  Get Started for $10Patent Expiration:Feb 8, 2034Product Flag?YSubstance Flag?YDelist Request?
Patent:  Get Started for $10Patent Expiration:Jan 16, 2023Product Flag?YSubstance Flag?YDelist Request?
Patent:  Get Started for $10Patent Expiration:Jan 16, 2023Product Flag?Substance Flag?Delist Request?

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