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INLYTA Drug Profile
» See Plans and Pricing
When do Inlyta patents expire, and when can generic versions of Inlyta launch?
Inlyta is a drug marketed by Pf Prism Cv and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and thirty-eight patent family members in fifty-six countries.
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.
DrugPatentWatch® Generic Entry Outlook for Inlyta
Inlyta was eligible for patent challenges on January 27, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 14, 2030. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are two tentative approvals for the generic drug (axitinib), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for INLYTA
| International Patents: | 138 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 103 |
| Clinical Trials: | 37 |
| Patent Applications: | 3,678 |
| Drug Prices: | Drug price information for INLYTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INLYTA |
| What excipients (inactive ingredients) are in INLYTA? | INLYTA excipients list |
| DailyMed Link: | INLYTA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for INLYTA
Generic Entry Date for INLYTA*:
Constraining patent/regulatory exclusivity:
NDA:
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 INLYTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1 |
| M.D. Anderson Cancer Center | Phase 1 |
| Nektar Therapeutics | Phase 1/Phase 2 |
Pharmacology for INLYTA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
US Patents and Regulatory Information for INLYTA
| 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 | 202324-002 | 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 | 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 | ||
| >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 INLYTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-002 | Jan 27, 2012 | Start Trial | Start Trial |
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for INLYTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 201691376 | Start Trial |
| Canada | 2383630 | Start Trial |
| China | 103626739 | Start Trial |
| Brazil | PI0809471 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for INLYTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1218348 | PA2013003,C1218348 | Lithuania | Start Trial | PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903 |
| 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 | C 2013 006 | Romania | Start Trial | PRODUCT NAME: AXITINIB,OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/777/001, RO EU/1/12/777/002, RO EU/1/12/777/003, RO EU/1/12/777/004, RO EU/1/12/777/005, RO EU/1/12/777/006; DATE OF NATIONAL AUTHORISATION: 20120903; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/777/001, EMEA EU/1/12/777/002, EMEA EU/1/12/777/003, EMEA EU/1/12/777/004, EMEA EU/1/12/777/005, EMEA EU/1/12/777/006; DATE OF FIRST AUTHORISATION IN EEA: 20120903 |
| 1218348 | 1390007-1 | Sweden | Start Trial | PRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 20120903 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
