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Neratinib maleate - Generic Drug Details
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What are the generic sources for neratinib maleate and what is the scope of freedom to operate?
Neratinib maleate
is the generic ingredient in one branded drug marketed by Puma Biotech and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Neratinib maleate has one hundred and twenty-two patent family members in twenty-nine countries.
One supplier is listed for this compound.
Summary for neratinib maleate
International Patents: | 122 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 19 |
Patent Applications: | 13 |
DailyMed Link: | neratinib maleate at DailyMed |
Pharmacology for neratinib maleate
Drug Class | Kinase Inhibitor |
Mechanism of Action | Kinase Inhibitors P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for neratinib maleate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | 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 neratinib maleate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for neratinib maleate
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2011500712 | Start Trial |
Israel | 205024 | Start Trial |
Spain | 2602123 | Start Trial |
Chile | 2008003088 | Start Trial |
Brazil | PI0818464 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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