PALONOSETRON HYDROCHLORIDE Drug Patent Profile
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Which patents cover Palonosetron Hydrochloride, and when can generic versions of Palonosetron Hydrochloride launch?
Palonosetron Hydrochloride is a drug marketed by Accord Hlthcare, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Rx, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Mylan Institutional, Nanjing King-friend, Novast Labs, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Avyxa Pharma, and Hikma. and is included in twenty-one NDAs.
The generic ingredient in PALONOSETRON HYDROCHLORIDE 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 Palonosetron Hydrochloride
A generic version of PALONOSETRON HYDROCHLORIDE was approved as palonosetron hydrochloride by SANDOZ on October 13th, 2015.
Summary for PALONOSETRON HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 18 |
NDAs: | 21 |
Finished Product Suppliers / Packagers: | 19 |
Raw Ingredient (Bulk) Api Vendors: | 101 |
Clinical Trials: | 122 |
Patent Applications: | 664 |
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 |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
Samsung Medical Center | N/A |
The Guthrie Clinic | Phase 4 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Accord Hlthcare | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 204615-001 | Mar 15, 2021 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Qilu Pharm Hainan | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 205648-001 | Sep 19, 2018 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Avyxa Pharma | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | SOLUTION;INTRAVENOUS | 203050-001 | Mar 1, 2016 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |