LEVOLEUCOVORIN CALCIUM Drug Patent Profile
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Which patents cover Levoleucovorin Calcium, and what generic alternatives are available?
Levoleucovorin Calcium is a drug marketed by Actavis Llc, Amneal, Hikma, Meitheal, Gland Pharma Ltd, Hainan Poly Pharm, Norvium Bioscience, Novast Labs, Praxgen, and Sandoz. and is included in thirteen NDAs.
The generic ingredient in LEVOLEUCOVORIN CALCIUM is levoleucovorin calcium. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Levoleucovorin Calcium
A generic version of LEVOLEUCOVORIN CALCIUM was approved as levoleucovorin calcium by SANDOZ on March 9th, 2015.
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Summary for LEVOLEUCOVORIN CALCIUM
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 46 |
| Clinical Trials: | 3 |
| Patent Applications: | 4,997 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEVOLEUCOVORIN CALCIUM |
| DailyMed Link: | LEVOLEUCOVORIN CALCIUM at DailyMed |
Recent Clinical Trials for LEVOLEUCOVORIN CALCIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Autism Speaks | Phase 2 |
| Phoenix Children's Hospital | Phase 2 |
| State University of New York - Downstate Medical Center | Phase 2 |
Pharmacology for LEVOLEUCOVORIN CALCIUM
| Drug Class | Folate Analog |
Medical Subject Heading (MeSH) Categories for LEVOLEUCOVORIN CALCIUM
Paragraph IV (Patent) Challenges for LEVOLEUCOVORIN CALCIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| FUSILEV | Injection | levoleucovorin calcium | 50 mg/vial | 020140 | 1 | 2013-12-19 |
| FUSILEV | Injection | levoleucovorin calcium | 10 mg/mL, 17.5 mL vial and 25 mL vial | 020140 | 1 | 2011-10-26 |
US Patents and Regulatory Information for LEVOLEUCOVORIN CALCIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Llc | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | POWDER;INTRAVENOUS | 206516-001 | Feb 13, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 203563-001 | Mar 9, 2015 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 210892-001 | Sep 14, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | POWDER;INTRAVENOUS | 206263-001 | Jun 16, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Meitheal | LEVOLEUCOVORIN CALCIUM | levoleucovorin calcium | SOLUTION;INTRAVENOUS | 211002-002 | Aug 16, 2019 | 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 |
