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, Hikma, Teva Pharms Usa, Novitium Pharma, Rising, and Sciegen Pharms Inc, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for levocarnitine. Seven suppliers are listed for this compound.

Summary for LEVOCARNITINE

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	12
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	24
Patent Applications:	6,874
Drug Prices:	Drug price trends for LEVOCARNITINE
What excipients (inactive ingredients) are in LEVOCARNITINE?	LEVOCARNITINE excipients list
DailyMed Link:	LEVOCARNITINE at DailyMed

See drug prices for LEVOCARNITINE

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

See all LEVOCARNITINE clinical trials

Pharmacology for LEVOCARNITINE

Drug Class	Carnitine Analog

Anatomical Therapeutic Chemical (ATC) Classes for LEVOCARNITINE

A16AA	Amino acids and derivatives
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for LEVOCARNITINE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sciegen Pharms Inc	LEVOCARNITINE	levocarnitine	SOLUTION;ORAL	212533-001	Nov 10, 2021	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	LEVOCARNITINE	levocarnitine	INJECTABLE;INJECTION	075881-001	Mar 29, 2001		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Leadiant Biosci Inc	CARNITOR	levocarnitine	TABLET;ORAL	018948-001	Dec 27, 1985	AB	RX	Yes	Yes	⤷ 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

Expired US Patents for LEVOCARNITINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leadiant Biosci Inc	CARNITOR	levocarnitine	INJECTABLE;INJECTION	020182-001	Dec 16, 1992	⤷ Sign Up	⤷ Sign Up
Leadiant Biosci Inc	CARNITOR	levocarnitine	INJECTABLE;INJECTION	020182-001	Dec 16, 1992	⤷ Sign Up	⤷ Sign Up
Leadiant Biosci Inc	CARNITOR	levocarnitine	INJECTABLE;INJECTION	020182-001	Dec 16, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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