LEVOCARNITINE Drug Patent Profile
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Which patents cover Levocarnitine, and when can generic versions of Levocarnitine launch?
Levocarnitine is a drug marketed by Am Regent, Hikma, Teva Pharms Usa, Lyne, Novitium Pharma, Saptalis Pharms, and Rising. and is included in nine NDAs.
The generic ingredient in LEVOCARNITINE is levocarnitine. There are four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Levocarnitine
A generic version of LEVOCARNITINE was approved as levocarnitine by HIKMA on March 29th, 2001.
Summary for LEVOCARNITINE
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 23 |
| Patent Applications: | 3,163 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LEVOCARNITINE |
| What excipients (inactive ingredients) are in LEVOCARNITINE? | LEVOCARNITINE excipients list |
| DailyMed Link: | LEVOCARNITINE at DailyMed |
Recent Clinical Trials for LEVOCARNITINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Children's Oncology Group | Phase 3 |
| Children's Hospital of Orange County | Early Phase 1 |
| University of California, Irvine | Early Phase 1 |
Pharmacology for LEVOCARNITINE
| Drug Class | Carnitine Analog |
Anatomical Therapeutic Chemical (ATC) Classes for LEVOCARNITINE
US Patents and Regulatory Information for LEVOCARNITINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | LEVOCARNITINE | levocarnitine | INJECTABLE;INJECTION | 075861-001 | Jun 22, 2001 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Saptalis Pharms | LEVOCARNITINE | levocarnitine | SOLUTION;ORAL | 212533-001 | Nov 10, 2021 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | LEVOCARNITINE | levocarnitine | SOLUTION;ORAL | 077399-001 | Oct 25, 2007 | AA | 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 |
