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, Meitheal, Mylan Institutional, Novast Labs, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, and Hikma. and is included in twenty NDAs.
The generic ingredient in PALONOSETRON HYDROCHLORIDE is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Twenty-one 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.
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Questions you can ask:
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Summary for PALONOSETRON HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 17 |
| NDAs: | 20 |
| Finished Product Suppliers / Packagers: | 20 |
| Raw Ingredient (Bulk) Api Vendors: | 101 |
| Clinical Trials: | 124 |
| Patent Applications: | 664 |
| 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Qilu Pharm Hainan | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 205648-001 | Sep 19, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | ||||
| Dr Reddys | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 201533-001 | Apr 21, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Baxter Hlthcare Corp | PALONOSETRON HYDROCHLORIDE | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 206916-001 | Nov 12, 2021 | AP | RX | 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 |
