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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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