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: | 6,920 |
| 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 |
| University of California, Irvine | Early Phase 1 |
| Children's Hospital of Orange County | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Leadiant Biosci Inc | CARNITOR | levocarnitine | TABLET;ORAL | 018948-001 | Dec 27, 1985 | AB | RX | Yes | Yes | ⤷ 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 | |||
| Leadiant Biosci Inc | CARNITOR SF | levocarnitine | SOLUTION;ORAL | 019257-002 | Mar 28, 2007 | AA | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Leadiant Biosci Inc | CARNITOR | levocarnitine | INJECTABLE;INJECTION | 020182-001 | Dec 16, 1992 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | LEVOCARNITINE | levocarnitine | TABLET;ORAL | 076858-001 | Sep 20, 2004 | AB | 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 | |||
| Novitium Pharma | LEVOCARNITINE SF | levocarnitine | SOLUTION;ORAL | 211676-002 | Aug 14, 2019 | AA | 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 |
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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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.
ISSN: 2162-2639
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