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, 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, Sandoz, Steriscience Speclts, Sun Pharm Inds (in), Teva, Wockhardt, Amneal Pharms, Aurobindo Pharma, Pharm Assoc, Taro, Apotex, Chartwell Molecules, Chartwell Rx, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hikma Intl Pharms, Ipca Labs Ltd, Natco Pharma Ltd, 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-seven 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.
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Questions you can ask:
- What is the 5 year forecast for ONDANSETRON HYDROCHLORIDE?
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- What is Average Wholesale Price for ONDANSETRON HYDROCHLORIDE?
Summary for ONDANSETRON HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 37 |
| NDAs: | 68 |
| Finished Product Suppliers / Packagers: | 65 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 615 |
| Patent Applications: | 1,391 |
| DailyMed Link: | ONDANSETRON HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ONDANSETRON HYDROCHLORIDE
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 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 |
US Patents and Regulatory Information for ONDANSETRON HYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | TABLET;ORAL | 076252-003 | Jun 25, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Molecules | ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | TABLET;ORAL | 077303-004 | Jun 25, 2007 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharm Assoc | ONDANSETRON HYDROCHLORIDE | ondansetron hydrochloride | SOLUTION;ORAL | 078127-001 | Jun 25, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ondansetron hydrochloride | INJECTABLE;INJECTION | 076696-001 | Dec 26, 2006 | 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 |
