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Last Updated: March 28, 2024

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
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
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:RXDosage:TABLET;ORALStrength75MG
Approval Date:Nov 1, 2019TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 8, 2034Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Aug 19, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Mar 5, 2027Product Flag?YSubstance Flag?YDelist Request?

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 ⤷  Try a Trial ⤷  Try a Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 ⤷  Try a Trial ⤷  Try a Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 ⤷  Try a Trial ⤷  Try a Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-002 Nov 1, 2019 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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