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Palonosetron hydrochloride - Generic Drug Details
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What are the generic sources for palonosetron hydrochloride and what is the scope of patent protection?
Palonosetron hydrochloride
is the generic ingredient in two branded drugs marketed by Helsinn Hlthcare, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, Ingenus Pharms Llc, Mylan Institutional, Qilu, Sagent Pharms Inc, Sandoz Inc, Teva Pharms Usa, Virtus Pharm, and Hikma, and is included in nineteen NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Palonosetron hydrochloride has fifty-three patent family members in forty countries.
There are twenty-one drug master file entries for palonosetron hydrochloride. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for palonosetron hydrochloride
International Patents: | 53 |
US Patents: | 13 |
Tradenames: | 2 |
Applicants: | 14 |
NDAs: | 19 |
Drug Master File Entries: | 21 |
Suppliers / Packagers: | 19 |
Bulk Api Vendors: | 85 |
Clinical Trials: | 108 |
Patent Applications: | 580 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for palonosetron hydrochloride |
What excipients (inactive ingredients) are in palonosetron hydrochloride? | palonosetron hydrochloride excipients list |
DailyMed Link: | palonosetron hydrochloride at DailyMed |
Recent Clinical Trials for palonosetron hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Instituto Brasileiro de Controle do Cancer | Phase 2 |
Theodor Bilharz Research Institute | Phase 4 |
Cairo University | Phase 4 |
Generic filers with tentative approvals for PALONOSETRON HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 0.25MG(BASE)/5ML | INJECTABLE;INJECTION |
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 palonosetron hydrochloride
Drug Class | Serotonin-3 Receptor Antagonist |
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Paragraph IV (Patent) Challenges for PALONOSETRON HYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ALOXI | INJECTABLE;INTRAVENOUS | palonosetron hydrochloride | 021372 | 2011-05-27 |
US Patents and Regulatory Information for 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 | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
Fresenius Kabi Usa | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 206802-001 | Sep 19, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Mylan Institutional | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 206416-001 | Sep 19, 2018 | AP | RX | No | No | Start Trial | Start Trial | Start 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 palonosetron hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | CAPSULE;ORAL | 022233-001 | Aug 22, 2008 | Start Trial | Start Trial |
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | Start Trial | Start Trial |
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for palonosetron hydrochloride
Country | Patent Number | Estimated Expiration |
---|---|---|
Costa Rica | 7921 | Start Trial |
Spain | 2315635 | Start Trial |
China | 1758911 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for palonosetron hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2785706 | 122020000046 | Germany | Start Trial | PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316 |
1035115 | 92745 | Luxembourg | Start Trial | PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527 |
2785706 | LUC00158 | Luxembourg | Start Trial | PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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