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 three branded drugs marketed by Helsinn Hlthcare, Accord Hlthcare, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Rx, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Novast Labs, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Hikma, and Avyxa Holdings, and is included in twenty-three 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 nineteen drug master file entries for palonosetron hydrochloride. Twenty-one 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: | 3 |
Applicants: | 19 |
NDAs: | 23 |
Drug Master File Entries: | 19 |
Finished Product Suppliers / Packagers: | 21 |
Raw Ingredient (Bulk) Api Vendors: | 101 |
Clinical Trials: | 124 |
Patent Applications: | 1,121 |
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 |
---|---|
SanQing Jin | N/A |
Sichuan Cancer Hospital and Research Institute | N/A |
Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
Generic filers with tentative approvals for PALONOSETRON HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for palonosetron hydrochloride
Paragraph IV (Patent) Challenges for PALONOSETRON HYDROCHLORIDE
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 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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Fresenius Kabi Usa | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 208109-001 | Nov 21, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novast Labs | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 208789-001 | May 22, 2020 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 207963-001 | Aug 22, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Dr Reddys | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 201533-001 | Apr 21, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 palonosetron hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-002 | Feb 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | CAPSULE;ORAL | 022233-001 | Aug 22, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372-001 | Jul 25, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for palonosetron hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2514224 | FORMULATIONS PHARMACEUTIQUES LIQUIDES DE PALONOSETRONE (LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON) | ⤷ Sign Up |
Norway | 20053987 | ⤷ Sign Up | |
Japan | 2011236242 | LIQUID PHARMACEUTICAL FORMULATION OF PALONOSETRON | ⤷ Sign Up |
Norway | 329500 | ⤷ Sign Up | |
Spain | 2315635 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for palonosetron hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2785706 | LUC00158 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AKYNZEO - FOSNETUPITANT/PALONOSETRON; AUTHORISATION NUMBER AND DATE: EU/1/15/1001 20200318 |
2785706 | 122020000046 | Germany | ⤷ Sign Up | PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316 |
0430190 | 18/2005 | Austria | ⤷ Sign Up | PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322 |
1035115 | 92745 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: NETUPITANT/PALONOSETRON ET LEURS DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (AKYNZEO); FIRST REGISTRATION: 20150527 |
0430190 | SPC/GB05/032 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: PALONOSETRON OR AN ISOMER, MIXTURE OF ISOMERS, N-OXIDE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/306/001 20050322 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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