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, Novitium Pharma, Rising, and Sciegen Pharms Inc. and is included in nine NDAs.
The generic ingredient in LEVOCARNITINE is levocarnitine. There are four drug master file entries for this compound. Seven 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.
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Questions you can ask:
- What is the 5 year forecast for LEVOCARNITINE?
- What are the global sales for LEVOCARNITINE?
- What is Average Wholesale Price for LEVOCARNITINE?
Summary for LEVOCARNITINE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 24 |
| Patent Applications: | 3,393 |
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sciegen Pharms Inc | LEVOCARNITINE | levocarnitine | SOLUTION;ORAL | 212533-001 | Nov 10, 2021 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | LEVOCARNITINE | levocarnitine | SOLUTION;ORAL | 077399-001 | Oct 25, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novitium Pharma | LEVOCARNITINE | levocarnitine | TABLET;ORAL | 216384-001 | Dec 9, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | LEVOCARNITINE | levocarnitine | INJECTABLE;INJECTION | 075567-001 | Mar 29, 2001 | AP | RX | 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 |
