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Last Updated: December 3, 2022

Fosnetupitant chloride hydrochloride; palonosetron hydrochloride - Generic Drug Details


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What are the generic drug sources for fosnetupitant chloride hydrochloride; palonosetron hydrochloride and what is the scope of freedom to operate?

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

Fosnetupitant chloride hydrochloride; palonosetron hydrochloride has one hundred and sixty-eight patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for fosnetupitant chloride hydrochloride; palonosetron hydrochloride
International Patents:168
US Patents:10
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:fosnetupitant chloride hydrochloride; palonosetron hydrochloride at DailyMed
Pharmacology for fosnetupitant chloride hydrochloride; palonosetron hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for fosnetupitant chloride hydrochloride; palonosetron hydrochloride
Paragraph IV (Patent) Challenges for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AKYNZEO Solution in SDV fosnetupitant chloride hydrochloride; palonosetron hydrochloride 235 mg/0.25 mg per 20 mL 210493 1 2022-04-19

US Patents and Regulatory Information for fosnetupitant chloride hydrochloride; palonosetron hydrochloride

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 fosnetupitant chloride hydrochloride; palonosetron hydrochloride POWDER;INTRAVENOUS 210493-001 Apr 19, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Helsinn Hlthcare AKYNZEO fosnetupitant chloride hydrochloride; palonosetron hydrochloride SOLUTION;INTRAVENOUS 210493-002 May 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for fosnetupitant chloride hydrochloride; palonosetron hydrochloride

Country Patent Number Title Estimated Expiration
Cuba 24048 COMPOSICIONES PARA TRATAR NÁUSEA Y VÓMITO CENTRALMENTE MEDIADOS See Plans and Pricing
European Patent Office 2722044 Compositions pour traiter les nausées et vomissements à médiation centrale (Compositions for treating centrally mediated nausea and vomiting) See Plans and Pricing
Philippines 12014501199 SUBSTITUTED 4-PHENYL - PYRIDINES FOR THE TREATMENT OF NK-1 RECEPTOR RELATED DISEASES See Plans and Pricing
Dominican Republic P2012000138 COMPOSICIONES PARA TRATAR NAUSEA Y VOMITO CENTRALMENTE MEDIADOS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fosnetupitant chloride hydrochloride; palonosetron hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2785706 2020C/516 Belgium See Plans and Pricing PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318
2785706 301047 Netherlands See Plans and Pricing PRODUCT NAME: FOSNETUPITANT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FOSNETUPITANTCHLORIDEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1001 20200318
2785706 122020000050 Germany See Plans and Pricing PRODUCT NAME: FOSNETUPITANT; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
2785706 2090015-5 Sweden See Plans and Pricing PRODUCT NAME: FOSNETUPITANT; REG. NO/DATE: EU/1/15/1001 20200317
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Express Scripts
AstraZeneca
Merck
Colorcon

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.