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LEVOCARNITINE - Generic Drug Details
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What are the generic sources for levocarnitine and what is the scope of freedom to operate?
Levocarnitine
is the generic ingredient in four branded drugs marketed by Leadiant Biosci Inc, Am Regent, Teva Pharms Usa, West-ward Pharms Int, Akorn, Lyne, Novitium Pharma, and Rising, and is included in ten NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Levocarnitine has four patent family members in four countries.
There are four drug master file entries for levocarnitine. Five suppliers are listed for this compound.
Summary for LEVOCARNITINE
International Patents: | 4 |
US Patents: | 3 |
Tradenames: | 4 |
Applicants: | 8 |
NDAs: | 10 |
Drug Master File Entries: | 4 |
Suppliers / Packagers: | 5 |
Bulk Api Vendors: | 96 |
Clinical Trials: | 10 |
Patent Applications: | 7,406 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends 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 |
---|---|
Mabaret Al-Asafara Hospitals | Phase 4 |
Vanderbilt University Medical Center | Phase 2 |
University of Guadalajara | Phase 2 |
Pharmacology for LEVOCARNITINE
Drug Class | Carnitine Analog |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Akorn | LEVOCARNITINE | levocarnitine | SOLUTION;ORAL | 077399-001 | Oct 25, 2007 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Lyne | LEVOCARNITINE | levocarnitine | SOLUTION;ORAL | 076851-001 | Aug 10, 2004 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Leadiant Biosci Inc | CARNITOR | levocarnitine | INJECTABLE;INJECTION | 020182-001 | Dec 16, 1992 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Leadiant Biosci Inc | CARNITOR | levocarnitine | SOLUTION;ORAL | 019257-001 | Apr 10, 1986 | AA | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
West-ward Pharms Int | LEVOCARNITINE | levocarnitine | INJECTABLE;INJECTION | 075567-001 | Mar 29, 2001 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LEVOCARNITINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Leadiant Biosci Inc | CARNITOR | levocarnitine | INJECTABLE;INJECTION | 020182-001 | Dec 16, 1992 | Start Trial | Start Trial |
Leadiant Biosci Inc | CARNITOR | levocarnitine | INJECTABLE;INJECTION | 020182-001 | Dec 16, 1992 | Start Trial | Start Trial |
Leadiant Biosci Inc | CARNITOR | levocarnitine | INJECTABLE;INJECTION | 020182-001 | Dec 16, 1992 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEVOCARNITINE
Country | Patent Number | Estimated Expiration |
---|---|---|
Australia | 3050201 | Start Trial |
World Intellectual Property Organization (WIPO) | 0152836 | Start Trial |
European Patent Office | 1257266 | Start Trial |
Canada | 2381187 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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