ONDANSETRON Drug Patent Profile
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When do Ondansetron patents expire, and what generic alternatives are available?
Ondansetron is a drug marketed by Aurobindo Pharma, Barr, Chartwell Molecules, Glenmark Pharms Ltd, Ipca Labs Ltd, Mylan, Nesher Pharms, Sandoz, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Accord Hlthcare, Am Regent, 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, Steriscience Speclts, Sun Pharm Inds (in), Wockhardt, Amneal Pharms, Pharm Assoc, Taro, Apotex, Chartwell Rx, Dr Reddys Labs Ltd, Hikma Intl Pharms, Natco Pharma Ltd, and Taro Pharms Ireland. and is included in seventy-nine NDAs.
The generic ingredient in ONDANSETRON is ondansetron hydrochloride. There are twenty-eight drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the ondansetron hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ondansetron
A generic version of ONDANSETRON was approved as ondansetron hydrochloride by FRESENIUS KABI USA on December 26th, 2006.
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Summary for ONDANSETRON
See drug prices for ONDANSETRON
Recent Clinical Trials for ONDANSETRON
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yongtao Sun | Phase 4 |
| King Saud Medical City | Phase 3 |
| Ain Shams University | N/A |
Pharmacology for ONDANSETRON
| Drug Class | Serotonin-3 Receptor Antagonist |
| Mechanism of Action | Serotonin 3 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for ONDANSETRON
Anatomical Therapeutic Chemical (ATC) Classes for ONDANSETRON
US Patents and Regulatory Information for ONDANSETRON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Ltd | ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | TABLET;ORAL | 076183-001 | Dec 26, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex Inc | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 077343-001 | Dec 26, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lannett Co Inc | ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | INJECTABLE;INJECTION | 090883-001 | Aug 5, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fresenius Kabi Usa | ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | INJECTABLE;INJECTION | 076974-001 | Dec 26, 2006 | 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 |
