Netupitant; palonosetron hydrochloride - Generic Drug Details

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What are the generic drug sources for netupitant; palonosetron hydrochloride and what is the scope of patent protection?

Netupitant; palonosetron hydrochloride is the generic ingredient in one branded drug marketed by Helsinn Hlthcare and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Netupitant; palonosetron hydrochloride has seventy-six patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for netupitant; palonosetron hydrochloride

International Patents:	76
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	17
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for netupitant; palonosetron hydrochloride
DailyMed Link:	netupitant; palonosetron hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for netupitant; palonosetron hydrochloride

Generic Entry Date for netupitant; palonosetron hydrochloride^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;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 netupitant; palonosetron hydrochloride

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

Sponsor	Phase
Sichuan Cancer Hospital and Research Institute	N/A
Helsinn Healthcare SA	Phase 4
Instituto Brasileiro de Controle do Cancer	Phase 2

See all netupitant; palonosetron hydrochloride clinical trials

Pharmacology for netupitant; palonosetron hydrochloride

Drug Class	Serotonin-3 Receptor Antagonist Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists P-Glycoprotein Inhibitors Serotonin 3 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for netupitant; palonosetron hydrochloride

A04AA	Serotonin (5HT3) antagonists
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for netupitant; palonosetron hydrochloride

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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
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014		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 netupitant; palonosetron hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014	⤷ Sign Up	⤷ Sign Up
Helsinn Hlthcare	AKYNZEO	netupitant; palonosetron hydrochloride	CAPSULE;ORAL	205718-001	Oct 10, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for netupitant; palonosetron hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Canada	2960599	FORMES CRISTALLINES D'UN ANTAGONISTE DES RECEPTEURS NK-1 (CRYSTALLINE FORMS OF AN NK-1 ANTAGONIST)	⤷ Sign Up
China	107050455	用于治疗中枢介导的恶心及呕吐的组合物及方法 (Compositions for treating centrally mediated uausea and vomiting)	⤷ Sign Up
Mexico	2012005347	COMPOSICIONES PARA TRATAR NAUSEA Y VOMITO CENTRALMENTE MEDIADOS. (COMPOSITIONS FOR TREATING CENTRALLY MEDIATED NAUSEA AND VOMITING.)	⤷ Sign Up
China	106512010	用于治疗中枢介导的恶心及呕吐的组合物及方法 (COMPOSITIONS FOR TREATING CENTRALLY MEDIATED NAUSEA AND VOMITING)	⤷ Sign Up
Georgia, Republic of	P20156226	COMPOSITIONS FOR TREATING CENTRALLY MEDIATED NAUSEA AND VOMITING	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for netupitant; palonosetron hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1035115	1590040-0	Sweden	⤷ Sign Up	PRODUCT NAME: NETUPITANT; REG. NO/DATE: EU/1/15/1001 20150529
2785706	2090015-5	Sweden	⤷ Sign Up	PRODUCT NAME: FOSNETUPITANT; REG. NO/DATE: EU/1/15/1001 20200317
1035115	C01035115/01	Switzerland	⤷ Sign Up	PRODUCT NAME: NETUPITANT; REGISTRATION NO/DATE: SWISSMEDIC 65499 06.11.2015
2785706	122020000050	Germany	⤷ Sign Up	PRODUCT NAME: FOSNETUPITANT; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
1035115	CA 2015 00044	Denmark	⤷ Sign Up	PRODUCT NAME: NETUPITANT; REG. NO/DATE: EU/1/15/1001 20150527
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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