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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 202324


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NDA 202324 describes INLYTA, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INLYTA profile page.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the axitinib profile page.
Summary for 202324
Tradename:INLYTA
Applicant:Pf Prism Cv
Ingredient:axitinib
Patents:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202324
Generic Entry Date for 202324*:
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: 202324
Suppliers and Packaging for NDA: 202324
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INLYTA axitinib TABLET;ORAL 202324 NDA Pfizer Laboratories Div Pfizer Inc 0069-0145 0069-0145-01 180 TABLET, FILM COATED in 1 BOTTLE (0069-0145-01)
INLYTA axitinib TABLET;ORAL 202324 NDA Pfizer Laboratories Div Pfizer Inc 0069-0151 0069-0151-11 60 TABLET, FILM COATED in 1 BOTTLE (0069-0151-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jan 27, 2012TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 3, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:IN COMBINATION WITH PEMBROLIZUMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
Patent:⤷  Try a TrialPatent Expiration:Jan 12, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:AXITINIB IN COMBINATION WITH AVELUMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
Patent:⤷  Try a TrialPatent Expiration:Apr 29, 2025Product Flag?YSubstance Flag?YDelist Request?

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