LEVOLEUCOVORIN - Generic Drug Details
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What are the generic sources for levoleucovorin and what is the scope of patent protection?
Levoleucovorin
is the generic ingredient in three branded drugs marketed by Acrotech Biopharma, Actavis Llc, Amneal, Hikma, Meitheal, Ailex Pharms Llc, Gland Pharma Ltd, Hainan Poly Pharm, Mylan Teoranta, Novast Labs, and Sandoz, and is included in fifteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for levoleucovorin. One supplier is listed for this compound.
Summary for LEVOLEUCOVORIN
| US Patents: | 1 |
| Tradenames: | 3 |
| Applicants: | 11 |
| NDAs: | 15 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 14 |
| Patent Applications: | 3,154 |
| Drug Prices: | Drug price trends for LEVOLEUCOVORIN |
| What excipients (inactive ingredients) are in LEVOLEUCOVORIN? | LEVOLEUCOVORIN excipients list |
| DailyMed Link: | LEVOLEUCOVORIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LEVOLEUCOVORIN
Generic Entry Date for LEVOLEUCOVORIN*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for LEVOLEUCOVORIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Seagen Inc. | Phase 3 |
| Eisai Inc. | Phase 3 |
| Merck Sharp & Dohme Corp. | Phase 3 |
Pharmacology for LEVOLEUCOVORIN
| Drug Class | Folate Analog |
US Patents and Regulatory Information for LEVOLEUCOVORIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Teoranta | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 203576-002 | Oct 20, 2015 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acrotech Biopharma | FUSILEV | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 020140-003 | Apr 29, 2011 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gland Pharma Ltd | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 210892-002 | Sep 14, 2018 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Meitheal | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | POWDER;INTRAVENOUS | 211003-001 | Aug 22, 2019 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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