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Generated: June 23, 2017
What is the patent landscape for Fusilev, and when can generic versions of Fusilev launch?
Fusilev is a drug marketed by Spectrum Pharms and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.| Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 8 |
| Clinical Trials: see list | 2 |
| Patent Applications: see list | 2,257 |
| Drug Prices: | see details |
| DailyMed Link: | FUSILEV at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Spectrum Pharms | FUSILEV | levoleucovorin calcium | POWDER;IV (INFUSION) | 020140-001 | Mar 7, 2008 | AP | RX | Yes | Yes | 6,500,829 | ► Subscribe | Y | Y | ► Subscribe | |||||||||||||||
Spectrum Pharms | FUSILEV | levoleucovorin calcium | SOLUTION;IV (INFUSION) | 020140-002 | Apr 29, 2011 | DISCN | Yes | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Spectrum Pharms | FUSILEV | levoleucovorin calcium | POWDER;IV (INFUSION) | 020140-001 | Mar 7, 2008 | AP | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Spectrum Pharms | FUSILEV | levoleucovorin calcium | SOLUTION;IV (INFUSION) | 020140-002 | Apr 29, 2011 | DISCN | Yes | No | 6,500,829 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Spectrum Pharms | FUSILEV | levoleucovorin calcium | SOLUTION;IV (INFUSION) | 020140-003 | Apr 29, 2011 | DISCN | Yes | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| levoleucovorin calcium | Injection | 10 mg/mL, 17.5 mL vial and 25 mL vial | Fusilev | 10/26/2011 |
| levoleucovorin calcium | Injection | 50 mg/vial | Fusilev | 12/19/2013 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4,959,472 | Process for preparing substantially pure diastereoisomers of tetrahydrofolic derivatives | ► Subscribe | |||||||||||||||||||||||||||
| 6,849,628 | Optically active compounds | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Spain | 2189782 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 8706562 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2191669 | ► Subscribe | |||||||||||||||||||||||||||
| United Kingdom | 8621268 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2844532 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
Export unavailable in trial.
Subscribe for complete access.
Serving 500+ biopharmaceutical companies globally:
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 verifification 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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