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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Neratinib maleate has one hundred and eighty-nine patent family members in thirty-five countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for neratinib maleate

International Patents:	189
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	3
Patent Applications:	281
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for neratinib maleate
DailyMed Link:	neratinib maleate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for neratinib maleate

Generic Entry Date for neratinib maleate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 neratinib maleate

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
National Cancer Institute (NCI)	Phase 1
Korea University Guro Hospital	Phase 2

See all neratinib maleate clinical trials

Generic filers with tentative approvals for NERATINIB MALEATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	40MG	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 neratinib maleate

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for neratinib maleate

L01EH	Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for NERATINIB MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NERLYNX	Tablets	neratinib maleate	40 mg	208051	1	2021-07-19

US Patents and Regulatory Information for neratinib maleate

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for neratinib maleate

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Country	Patent Number	Title	Estimated Expiration
Croatia	P20192026		⤷ Sign Up
South Korea	20220143154	네라티닙을 이용한 유방암의 치료법 (TREATMENT REGIMEN UTILIZING NERATINIB FOR BREAST CANCER)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011055303		⤷ Sign Up
Slovenia	2498756		⤷ Sign Up
New Zealand	599763	Tablet formulations of neratinib maleate	⤷ Sign Up
Denmark	3000467		⤷ Sign Up
South Korea	20140036332	TREATMENT REGIMEN UTILIZING NERATINIB FOR BREAST CANCER	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for neratinib maleate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3000467	301237	Netherlands	⤷ Sign Up	PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 20180904
3000467	26/2023	Austria	⤷ Sign Up	PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 (MITTEILUNG) 20180904
3000467	2390021-0	Sweden	⤷ Sign Up	PRODUCT NAME: NERATINIB; REG. NO/DATE: EU/1/18/1311 20180904
3000467	2023C/527	Belgium	⤷ Sign Up	PRODUCT NAME: NERATINIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1311 20180904
3000467	LUC00310	Luxembourg	⤷ Sign Up	PRODUCT NAME: NERATINIB; AUTHORISATION NUMBER AND DATE: EU/1/18/1311 20180904
3000467	CA 2023 00021	Denmark	⤷ Sign Up	PRODUCT NAME: NERATINIB; REG. NO/DATE: EU/1/18/1311 20180904
3000467	122023000045	Germany	⤷ Sign Up	PRODUCT NAME: NERATINIB; REGISTRATION NO/DATE: EU/1/18/1311 20180831
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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