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Sign in to subscribeLevocarnitine Oral Solution
Matched- Active ingredients (original)
- LEVOCARNITINE
- Dosage form (original)
- SOLUTION
- Route (original)
- ORAL
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approval1986/04/10
ANDA applications4
RLD applicantLEADIANT BIOSCIENCES INC
Currently marketed products: 6 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| A076851-001 | LEVOCARNITINE | RISING PHARMA HOLDINGS INC | SOLUTION | ORAL | LEVOCARNITINE: 1GM/10ML | 2004/08/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077399-001 | LEVOCARNITINE | HIKMA PHARMACEUTICALS USA INC | SOLUTION | ORAL | LEVOCARNITINE: 1GM/10ML | 2007/10/25 | N / N | DISCONTINUED | openFDA ↗ |
| A211676-001 | LEVOCARNITINE | NOVITIUM PHARMA LLC | SOLUTION | ORAL | LEVOCARNITINE: 1GM/10ML | 2019/08/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211676-002 | LEVOCARNITINE SF | NOVITIUM PHARMA LLC | SOLUTION | ORAL | LEVOCARNITINE: 1GM/10ML | 2019/08/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A212533-001 | LEVOCARNITINE | SCIEGEN PHARMACEUTICALS INC | SOLUTION | ORAL | LEVOCARNITINE: 1GM/10ML | 2021/11/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N018948-002 | CARNITOR | LEADIANT BIOSCIENCES INC | SOLUTION | ORAL | LEVOCARNITINE: 1GM/10ML | 1988/04/27 | N / N | DISCONTINUED | openFDA ↗ |
| N019257-001 | CARNITOR | LEADIANT BIOSCIENCES INC | SOLUTION | ORAL | LEVOCARNITINE: 1GM/10ML | 1986/04/10 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N019257-002 | CARNITOR SF | LEADIANT BIOSCIENCES INC | SOLUTION | ORAL | LEVOCARNITINE: 1GM/10ML | 2007/03/28 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration—
Substance patent expiration (DS flag)—
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Catalog holders 1
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| ALFASIGMA S.p.A. | H2017130710ml:1g | 2013/06/26 | Official source ↗ |
| ALFASIGMA S.p.A. | H2017130810ml:2g | 2013/06/26 | Official source ↗ |
NHSA approval numbers 37
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H2025556510ml:1g | — | Official source ↗ |
| Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H2010344810ml:1g | — | Official source ↗ |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H1999037210ml:1g | — | Official source ↗ |
| Dong Yao Group Shenyang Shi De Pharma Co., Ltd. romanized | 国药准字H2025379910ml:1g | — | Official source ↗ |
| Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized | 国药准字H2000052210ml:1g | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H2025453010ml:1g | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H2025454410ml:1g | — | Official source ↗ |
| Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2025554410ml:1g | — | Official source ↗ |
| Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized | 国药准字H2026429410ml:1g | — | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H2012310010ml:1g | — | Official source ↗ |
| Shandong Yi Kang Pharma Co., Ltd. romanized | 国药准字H2020310910ml:1g | — | Official source ↗ |
| Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 国药准字H2024400510ml:1g | — | Official source ↗ |
| Zhejiang Kai Run Pharma Co., Ltd. romanized | 国药准字H2022362210ml:1g | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H2026528510ml:1g | — | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | 国药准字H2026335910ml:1g | — | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2017333710ml:1g | — | Official source ↗ |
| Beijing Kang Zhen Bio Technology Co., Ltd. romanized | 国药准字H2024913510ml:1g | — | Official source ↗ |
| Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H2025471310ml:1g | — | Official source ↗ |
| Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized | 国药准字H2025495010ml:1g | — | Official source ↗ |
| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | H2017106110ml:1g | — | Official source ↗ |
| ALFASIGMA S.p.A. | H2017130710ml:1g | — | Official source ↗ |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | 国药准字H2019309810ml:1g | — | Official source ↗ |
| Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 国药准字H2026502010ml∶1g | — | Official source ↗ |
| Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized | 国药准字H2024417810ml:1g | — | Official source ↗ |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H2025452910ml:1g | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H2026550010ml:1g | — | Official source ↗ |
| Sichuan Jia Chuang Jing Tai Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H2023359710ml:1g | — | Official source ↗ |
| Gu Ge Er Pharma (Hainan) Co., Ltd. romanized | 国药准字H2024918910ml:1g | — | Official source ↗ |
| Jiangsu Bai Ao Xin Kang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2024949510ml:1g | — | Official source ↗ |
| Hubei Xin Ze Fei Pharma Co., Ltd. romanized | 国药准字H2024302610ml:1g | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H2024900910ml:1g | — | Official source ↗ |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | 国药准字H2026483510ml∶1g | — | Official source ↗ |
| Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H2010344810ml:1g | — | Official source ↗ |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H1999037210ml:1g | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H2025453010ml:1g | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H2025454410ml:1g | — | Official source ↗ |
| Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2025554410ml:1g | — | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H2012310010ml:1g | — | Official source ↗ |
| Shandong Yi Kang Pharma Co., Ltd. romanized | 国药准字H2020310910ml:1g | — | Official source ↗ |
| Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 国药准字H2024400510ml:1g | — | Official source ↗ |
| Zhejiang Kai Run Pharma Co., Ltd. romanized | 国药准字H2022362210ml:1g | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H2026528510ml:1g | — | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2017333710ml:1g | — | Official source ↗ |
| Beijing Kang Zhen Bio Technology Co., Ltd. romanized | 国药准字H2024913510ml:1g | — | Official source ↗ |
| Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H2025471310ml:1g | — | Official source ↗ |
| ALFASIGMA S.p.A. | H2017130710ml:1g | — | Official source ↗ |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | 国药准字H2019309810ml:1g | — | Official source ↗ |
| Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 国药准字H2026502010ml∶1g | — | Official source ↗ |
| Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized | 国药准字H2024417810ml:1g | — | Official source ↗ |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H2025452910ml:1g | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H2026550010ml:1g | — | Official source ↗ |
| Jiangsu Bai Ao Xin Kang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2024949510ml:1g | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H2024900910ml:1g | — | Official source ↗ |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | 国药准字H2026483510ml∶1g | — | Official source ↗ |
| Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H2010344810ml:1g | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H2025454410ml:1g | — | Official source ↗ |
| Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2025554410ml:1g | — | Official source ↗ |
| Shandong Yi Kang Pharma Co., Ltd. romanized | 国药准字H2020310910ml:1g | — | Official source ↗ |
| Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 国药准字H2024400510ml:1g | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H2026528510ml:1g | — | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2017333710ml:1g | — | Official source ↗ |
| Beijing Kang Zhen Bio Technology Co., Ltd. romanized | 国药准字H2024913510ml:1g | — | Official source ↗ |
| Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H2025471310ml:1g | — | Official source ↗ |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | 国药准字H2019309810ml:1g | — | Official source ↗ |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H2025452910ml:1g | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H2026550010ml:1g | — | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H2024900910ml:1g | — | Official source ↗ |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | 国药准字H2026483510ml∶1g | — | Official source ↗ |
| Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H2010344810ml:1g | — | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 国药准字H2025454410ml:1g | — | Official source ↗ |
| Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2025554410ml:1g | — | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2017333710ml:1g | — | Official source ↗ |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H2025452910ml:1g | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H2026550010ml:1g | — | Official source ↗ |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | 国药准字H2026483510ml∶1g | — | Official source ↗ |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H2025452910ml:1g | — | Official source ↗ |
| Jiangsu Tian Ping Pharma Co., Ltd. romanized | 国药准字H2026483510ml∶1g | — | Official source ↗ |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H2025452910ml:1g | — | Official source ↗ |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H1999037210ml:1g | — | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H2012310010ml:1g | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H2026528410ml:2g | — | Official source ↗ |
| Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H2025471410ml:2g | — | Official source ↗ |
| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | H2017105810ml:2g | — | Official source ↗ |
| ALFASIGMA S.p.A. | 国药准字HJ2017130810ml: 2g | — | Official source ↗ |
| Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized | 国药准字H2024417910ml:2g | — | Official source ↗ |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H1999037210ml:1g | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H2026528410ml:2g | — | Official source ↗ |
| Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H2025471410ml:2g | — | Official source ↗ |
| ALFASIGMA S.p.A. | 国药准字HJ2017130810ml: 2g | — | Official source ↗ |
| Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized | 国药准字H2024417910ml:2g | — | Official source ↗ |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 国药准字H2026528410ml:2g | — | Official source ↗ |
| Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized | 国药准字H2024417910ml:2g | — | Official source ↗ |
Under review 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yunnan Hai Feng Pharma Co., Ltd. romanized | CYHS2602332 | 2026/09/18 | Official source ↗ |
| Jin Zhou Ben Tian Pharma Co., Ltd. romanized | CYHS2504414 | 2025/12/26 | Official source ↗ |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2504325 | 2025/12/19 | Official source ↗ |
| Beijing Liu Huan Pharma Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | CYHS2503485 | 2025/09/22 | Official source ↗ |
| Beijing Liu Huan Pharma Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | CYHS2503484 | 2025/09/22 | Official source ↗ |
| Shandong Kang Lin Pharmaceuticals Co., Ltd. romanized; Shandong Yi Kang Pharma Co., Ltd. romanized | CYHS2503224 | 2025/09/02 | Official source ↗ |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2502276 | 2025/06/26 | Official source ↗ |
| Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized | CYHS2502061 | 2025/06/11 | Official source ↗ |
| Jiangxi Zhong Ze Yuan Pharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized | CYHS2602672 | 2026/11/02 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yunnan Hai Feng Pharma Co., Ltd. romanized | CYHS2602332 | 2026/09/18 | Official source ↗ |
| Jiangxi Zhong Ze Yuan Pharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized | CYHS2602672 | 2026/11/02 | Official source ↗ |
API companies with A status 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jilin Sheng Si He Pharma Technology Co., Ltd. romanized | Y20230001159 | 2025/07/21 | Official source ↗ |
| Zhejiang Zhu Zi Pharmaceutical Co., Ltd. romanized | Y20230001188 | 2026/07/28 | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | Y20230001051 | 2025/08/19 | Official source ↗ |
| Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Y20230000689 | 2025/04/16 | Official source ↗ |
| Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | Y20220001204 | 2025/02/28 | Official source ↗ |
| Hong Bo Zhi Yuan (Kai Yuan) Pharma Co., Ltd. romanized | Y20210001266 | 2025/09/04 | Official source ↗ |
| Shanghai Bo Teng Zhi Tuo Pharmaceuticals Technology Co., Ltd. romanized | Y20210000770 | 2024/11/12 | Official source ↗ |
| Cheng Da Pharma Co., Ltd. romanized | Y20200000014 | 2023/05/24 | Official source ↗ |
| Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized | Y20190003752 | 2026/10/09 | Official source ↗ |
| Dong Bei Pharmaceutical Group Co., Ltd. romanized | Y20190003163 | 2024/04/24 | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | Y20170001602 | 2025/08/23 | Official source ↗ |
| Liaoning Nuo Wei Nuo Pharmaceutical Co., Ltd. romanized | Y20170000014 | 2023/12/27 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 23-257 · 2020/01/03
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