ONDANSETRON HYDROCHLORIDE Drug Patent Profile
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When do Ondansetron Hydrochloride patents expire, and when can generic versions of Ondansetron Hydrochloride launch?
Ondansetron Hydrochloride is a drug marketed by Accord Hlthcare, Apotex Inc, Avet Lifesciences, Baxter Hlthcare Corp, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Lannett Co Inc, Luitpold, Pliva Hrvatska Doo, Qilu Pharm Hainan, Rising, Sagent Pharms, Sandoz, Steriscience, Sun Pharm Inds (in), Teva, Wockhardt, Amneal Pharms, Aurobindo Pharma, Pharm Assoc, Taro, Apotex, Casi Pharms Inc, Chartwell Molecules, Dr Reddys Labs Ltd, Glenmark Generics, Hikma Intl Pharms, Ipca Labs Ltd, Natco Pharma Ltd, Am Regent, Sun Pharm Inds Ltd, and Taro Pharms Ireland. and is included in sixty-eight NDAs.
The generic ingredient in ONDANSETRON HYDROCHLORIDE is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ondansetron Hydrochloride
A generic version of ONDANSETRON HYDROCHLORIDE was approved as ondansetron hydrochloride by FRESENIUS KABI USA on December 26th, 2006.
Summary for ONDANSETRON HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 37 |
NDAs: | 68 |
Finished Product Suppliers / Packagers: | 61 |
Raw Ingredient (Bulk) Api Vendors: | 81 |
Clinical Trials: | 610 |
Patent Applications: | 1,392 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ONDANSETRON HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ONDANSETRON HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University | Phase 4 |
Adwia Pharma, Egypt | Phase 3 |
Purdue University | Phase 4 |
Pharmacology for ONDANSETRON HYDROCHLORIDE
Drug Class | Serotonin-3 Receptor Antagonist |
Mechanism of Action | Serotonin 3 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ONDANSETRON HYDROCHLORIDE
Paragraph IV (Patent) Challenges for ONDANSETRON HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZOFRAN | Oral Solution | ondansetron hydrochloride | 4 mg/5 mL | 020605 | 1 | 2004-12-20 |