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Last Updated: March 19, 2024

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 seventy-two patent family members in fifty-seven 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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for axitinib
Generic Entry Date for axitinib*:
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.

Recent Clinical Trials for axitinib

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

SponsorPhase
Lynkcell EuropePhase 1
Hao ZengPhase 1/Phase 2
ZHOU FANGJIANPhase 2

See all axitinib clinical trials

Generic filers with tentative approvals for AXITINIB
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial5MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial1MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial5MGTABLET;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 Strength NDA ANDAs Submitted Submissiondate
INLYTA Tablets axitinib 1 mg and 5 mg 202324 1 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 202324-002 Jan 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for axitinib

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Europe MA EEIG  Inlyta axitinib EMEA/H/C/002406
Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
Authorised no no no 2012-09-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for axitinib

Country Patent Number Title Estimated Expiration
Taiwan 201709933 PD-L1 antagonist combination treatments ⤷  Try a Trial
Algeria 3191 Composés d'indazole et compositions pharmaceutiques inhibant les protéines kinases, et procédés d'utilisation de ceux-ci. ⤷  Try a Trial
Hungary 228502 INDAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS FOR INHIBITING PROTEIN KINASES, AND METHODS FOR THEIR USE ⤷  Try a Trial
Estonia 200100717 ⤷  Try a Trial
Luxembourg 92154 ⤷  Try a Trial
Guatemala 200000107 PROCEDIMIENTO PARA LA OBTENCION DE "COMPUESTOS DE INDAZOL Y COMPOSICIONES FARMACEUTICAS PARA INHIBIR LAS QUINASAS DEPROTEINA Y METODOS PARA SU USO". ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for axitinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1218348 CR 2013 00010 Denmark ⤷  Try a Trial PRODUCT NAME: AXITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/777/001-006 20120903
1218348 C01218348/01 Switzerland ⤷  Try a Trial FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US
1218348 PA2013003,C1218348 Lithuania ⤷  Try a Trial PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 438 Finland ⤷  Try a Trial
1218348 PA2013003 Lithuania ⤷  Try a Trial PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 122013000016 Germany ⤷  Try a Trial PRODUCT NAME: AXITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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