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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 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: | 101 |
Clinical Trials: | 124 |
Patent Applications: | 2,985 |
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
Sponsor | Phase |
---|---|
Ipsen | Phase 2 |
Asan Medical Center | Phase 2 |
Southwest Oncology Group | Phase 3 |
Generic filers with tentative approvals for AXITINIB
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 5MG | TABLET;ORAL |
Start Trial | Start Trial | 1MG | TABLET;ORAL |
Start Trial | Start Trial | 5MG | TABLET;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
Drug Class | Kinase Inhibitor |
Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
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 | 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 | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for axitinib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | Start Trial | Start Trial |
Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-002 | Jan 27, 2012 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for axitinib
Country | Patent Number | Estimated Expiration |
---|---|---|
Norway | 2013004 | Start Trial |
Yugoslavia | 92901 | Start Trial |
Slovenia | 1218348 | Start Trial |
Iceland | 2791 | Start Trial |
Estonia | 05585 | Start Trial |
Norway | 20015797 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for axitinib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1218348 | 2013C/015 | Belgium | Start Trial | PRODUCT NAME: AXITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/777/001 20120905 |
1218348 | C300576 | Netherlands | Start Trial | PRODUCT NAME: AXITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903 |
1218348 | 92154 | Luxembourg | Start Trial | PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE |
1218348 | C01218348/01 | Switzerland | Start Trial | FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US |
1218348 | 5/2013 | Austria | Start Trial | PRODUCT NAME: AXITINIB; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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