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Last Updated: May 11, 2021

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AXITINIB - Generic Drug Details

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What are the generic drug sources for axitinib and what is the scope of freedom to operate?

Axitinib is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Axitinib has one hundred and fifty patent family members in fifty-six countries.

There are four drug master file entries for axitinib. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for AXITINIB
Recent Clinical Trials for AXITINIB

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Asan Medical CenterPhase 2
IpsenPhase 2
National Cancer Institute (NCI)Phase 3

See all AXITINIB clinical trials

Generic filers with tentative approvals for AXITINIB
Applicant Application No. Strength Dosage Form
  Get Started for $10  Get Started for $105MGTABLET;ORAL
  Get Started for $10  Get Started for $101MGTABLET;ORAL
  Get Started for $10  Get Started for $105MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

US Patents and Regulatory Information for AXITINIB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for AXITINIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1218348 CA 2013 00010 Denmark   Get Started for $10
1218348 1390007-1 Sweden   Get Started for $10 PRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 20120903
1218348 PA2013003 Lithuania   Get Started for $10 PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 PA2013003,C1218348 Lithuania   Get Started for $10 PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 CR 2013 00010 Denmark   Get Started for $10 PRODUCT NAME: AXITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/777/001-006 20120903
1218348 5/2013 Austria   Get Started for $10 PRODUCT NAME: AXITINIB; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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