ZOFRAN Drug Patent Profile
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When do Zofran patents expire, and what generic alternatives are available?
Zofran is a drug marketed by Sandoz and Glaxosmithkline and is included in five NDAs.
The generic ingredient in ZOFRAN is ondansetron. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zofran
A generic version of ZOFRAN was approved as ondansetron by CHARTWELL MOLECULES on December 26th, 2006.
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Summary for ZOFRAN
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 136 |
| Clinical Trials: | 161 |
| Patent Applications: | 4,048 |
| Drug Prices: | Drug price information for ZOFRAN |
| Drug Sales Revenues: | Drug sales revenues for ZOFRAN |
| What excipients (inactive ingredients) are in ZOFRAN? | ZOFRAN excipients list |
| DailyMed Link: | ZOFRAN at DailyMed |
Recent Clinical Trials for ZOFRAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tanta University | Phase 3 |
| Tanta University | Phase 2/Phase 3 |
| Emory University | Phase 2 |
Paragraph IV (Patent) Challenges for ZOFRAN
| 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 ZOFRAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | ZOFRAN | ondansetron hydrochloride | INJECTABLE;INJECTION | 020007-001 | Jan 4, 1991 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-001 | Jan 27, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | ZOFRAN | ondansetron hydrochloride | TABLET;ORAL | 020103-002 | Dec 31, 1992 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | ZOFRAN ODT | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 020781-002 | Jan 27, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | ZOFRAN | ondansetron hydrochloride | SOLUTION;ORAL | 020605-001 | Jan 24, 1997 | DISCN | Yes | 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 |
Expired US Patents for ZOFRAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | ZOFRAN | ondansetron hydrochloride | TABLET;ORAL | 020103-001 | Dec 31, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN | ondansetron hydrochloride | TABLET;ORAL | 020103-003 | Aug 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN | ondansetron hydrochloride | SOLUTION;ORAL | 020605-001 | Jan 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN | ondansetron hydrochloride | TABLET;ORAL | 020103-001 | Dec 31, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | ZOFRAN | ondansetron hydrochloride | TABLET;ORAL | 020103-001 | Dec 31, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZOFRAN
See the table below for patents covering ZOFRAN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 297879 | ONDANSETRON AND POLYHYDRIC ALCOHOL (A SWEETENER) IN A LIQUID ACIDIC ORAL COMPOSITION FORM | ⤷ Sign Up |
| Italy | 8748643 | ⤷ Sign Up | |
| United Kingdom | 8401888 | ⤷ Sign Up | |
| Sweden | 460359 | 3-IMIDAZOLYLMETYLTETRAHYDROKARBAZOLONER, FOERFARANDE FOER FRAMSTAELLNING AV DESSA OCH EN FARMACEUTISK KOMPOSITION | ⤷ Sign Up |
| Japan | H10508866 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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