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Last Updated: April 17, 2021

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Axitinib - Generic Drug Details

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What are the generic sources for axitinib and what is the scope of patent protection?

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 thirty-eight 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
International Patents:138
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
Suppliers / Packagers: 2
Bulk Api Vendors: 103
Clinical Trials: 124
Patent Applications: 7,798
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for axitinib
What excipients (inactive ingredients) are in axitinib?axitinib excipients list
DailyMed Link:axitinib at DailyMed
Recent Clinical Trials for axitinib

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

SponsorPhase
IpsenPhase 2
Asan Medical CenterPhase 2
Southwest Oncology GroupPhase 3

See all axitinib clinical trials

Generic filers with tentative approvals for AXITINIB
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MGTABLET;ORAL
  Start Trial  Start Trial1MGTABLET;ORAL
  Start Trial  Start 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 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   Start Trial   Start Trial   Start Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-002 Jan 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv INLYTA axitinib TABLET;ORAL 202324-001 Jan 27, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
>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 5/2013 Austria   Start Trial PRODUCT NAME: AXITINIB; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 PA2013003 Lithuania   Start Trial PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348 92154 Luxembourg   Start Trial PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE
1218348 CR 2013 00010 Denmark   Start Trial PRODUCT NAME: AXITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/777/001-006 20120903
1218348 2013/008 Ireland   Start Trial PRODUCT NAME: AXITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/12/777/001 EU/1/12/777/006 20120903
1218348 PA2013003,C1218348 Lithuania   Start Trial PRODUCT NAME: AXITINIBUM; 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Merck
Boehringer Ingelheim
McKinsey
Mallinckrodt

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