ALOXI Drug Patent Profile
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When do Aloxi patents expire, and what generic alternatives are available?
Aloxi is a drug marketed by Helsinn Hlthcare and is included in two NDAs. There are thirteen patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-three patent family members in forty countries.
The generic ingredient in ALOXI is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aloxi
A generic version of ALOXI was approved as palonosetron hydrochloride by SANDOZ on October 13th, 2015.
Summary for ALOXI
International Patents: | 53 |
US Patents: | 13 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 156 |
Patent Applications: | 4,101 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ALOXI |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ALOXI |
What excipients (inactive ingredients) are in ALOXI? | ALOXI excipients list |
DailyMed Link: | ALOXI at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for ALOXI
Paragraph IV (Patent) Challenges for ALOXI
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ALOXI | Injection | palonosetron hydrochloride | 0.05 mg/mL, 1.5 mL and 5 mL vials | 021372 | 3 | 2011-05-27 |
US Patents and Regulatory Information for ALOXI
ALOXI is protected by seven US patents.
Patents protecting ALOXI
Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liquid pharmaceutical formulations of palonosetron
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | CAPSULE;ORAL | 022233-001 | Aug 22, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 ALOXI
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | CAPSULE;ORAL | 022233-001 | Aug 22, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ALOXI
See the table below for patents covering ALOXI around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 905120 | ⤷ Try a Trial | |
Israel | 169859 | פורמולציות רוקחיות נוזליות של פאלונוסטרון (Liquid pharmaceutical formulations of palonosetron) | ⤷ Try a Trial |
Japan | H0662607 | ⤷ Try a Trial | |
Japan | 2006516583 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALOXI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2785706 | LUC00158 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318 |
0430190 | 18/2005 | Austria | ⤷ Try a Trial | PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322 |
0430190 | CA 2005 00023 | Denmark | ⤷ Try a Trial | |
2785706 | C02785706/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |