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Last Updated: April 11, 2021

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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
Drug Prices for LEVOCARNITINE

See drug prices for LEVOCARNITINE

Recent Clinical Trials for LEVOCARNITINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mabaret Al-Asafara HospitalsPhase 4
Vanderbilt University Medical CenterPhase 2
University of GuadalajaraPhase 2

See all LEVOCARNITINE clinical trials

Pharmacology 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
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

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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.