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Last Updated: July 14, 2020

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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 three 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
Applicant:Pf Prism Cv
Generic Entry Opportunity Date for 202324
Generic Entry Date for 202324*:
Constraining patent/regulatory exclusivity:

*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)
Paragraph IV (Patent) Challenges for 202324
Tradename Dosage Ingredient NDA Submissiondate
INLYTA TABLET;ORAL axitinib 202324 2018-02-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jan 27, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 29, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Jun 30, 2020Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Dec 14, 2030Product Flag?Substance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.