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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fosnetupitant chloride hydrochloride; palonosetron hydrochloride has one hundred and seventy-seven patent family members in fifty-one countries.
One supplier is listed for this compound.
Summary for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
International Patents: | 177 |
US Patents: | 11 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE |
DailyMed Link: | FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Generic Entry Date for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS |
*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.
Pharmacology for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Drug Class | Serotonin-3 Receptor Antagonist |
Mechanism of Action | Serotonin 3 Receptor Antagonists |
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 | SOLUTION;INTRAVENOUS | 210493-002 | May 27, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Helsinn Hlthcare | AKYNZEO | fosnetupitant chloride hydrochloride; palonosetron hydrochloride | POWDER;INTRAVENOUS | 210493-001 | Apr 19, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Helsinn Hlthcare | AKYNZEO | fosnetupitant chloride hydrochloride; palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 210493-002 | May 27, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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 |
International Patents for FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ukraine | 105817 | КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ТОШНОТЫ И РВОТЫ ЦЕНТРАЛЬНОГО ПРОИСХОЖДЕНИЯ;КОМПОЗИЦІЇ ДЛЯ ЛІКУВАННЯ НУДОТИ І БЛЮВАННЯ ЦЕНТРАЛЬНОГО ПОХОДЖЕННЯ (Normal;heading 1;heading 2;heading 3;COMPOSITIONS FOR TREATING CENTRALLY MEDIATED NAUSEA AND VOMITING) | ⤷ Sign Up |
Morocco | 35836 | 4 phényl-pyridines substituées pour le traitement de maladies associées à un récepteur nk-1 | ⤷ Sign Up |
Morocco | 33810 | تركيبات لعلاج الغثيان والقيء بالوساطة مركزية | ⤷ Sign Up |
>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 | 132020000000094 | Italy | ⤷ Sign Up | PRODUCT NAME: FOSNETUPITANT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL SUO SALE CLORURO CLORIDRATO(AKYNZEO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1001/001-002, 20200316 |
2785706 | PA2020510 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FOSNETUPITANTAS; REGISTRATION NO/DATE: EU/1/15/1001 20200316 |
2785706 | 2090015-5 | Sweden | ⤷ Sign Up | 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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