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, Lyne, Novitium Pharma, Sciegen Pharms Inc, and Rising, 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: | 8 |
NDAs: | 12 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 111 |
Clinical Trials: | 24 |
Patent Applications: | 6,920 |
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 |
---|---|
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novitium Pharma | LEVOCARNITINE | levocarnitine | TABLET;ORAL | 216384-001 | Dec 9, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lyne | LEVOCARNITINE | levocarnitine | SOLUTION;ORAL | 076851-001 | Aug 10, 2004 | AA | 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 | |||
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
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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