Monthly
US$200
Billed every month
Sign in to subscribeLevetiracetam Oral Solution
Matched- Active ingredients (original)
- LEVETIRACETAM
- 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 approval2003/07/15
ANDA applications20
RLD applicantUCB INC
Currently marketed products: 14 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A078582-001 | LEVETIRACETAM | STRIDES PHARMA GLOBAL PTE LTD | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2009/01/15 | N / N | DISCONTINUED | openFDA ↗ |
| A078774-001 | LEVETIRACETAM | TARO PHARMACEUTICAL INDUSTRIES LTD | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2009/02/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078976-001 | LEVETIRACETAM | ACTAVIS MID ATLANTIC LLC | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2009/01/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A079063-001 | LEVETIRACETAM | AUROBINDO PHARMA LTD | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2009/01/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A079107-001 | LEVETIRACETAM | TOLMAR INC | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2009/01/15 | N / N | DISCONTINUED | openFDA ↗ |
| A079120-001 | LEVETIRACETAM | BIONPHARMA INC | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2009/01/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090028-001 | LEVETIRACETAM | PHARMOBEDIENT CONSULTING | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2010/03/03 | N / N | DISCONTINUED | openFDA ↗ |
| A090079-001 | LEVETIRACETAM | QUAGEN PHARMACEUTICALS LLC | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2012/04/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090187-001 | LEVETIRACETAM | APOTEX INC | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2011/08/05 | N / N | DISCONTINUED | openFDA ↗ |
| A090263-001 | LEVETIRACETAM | CHARTWELL MOLECULAR HOLDINGS LLC | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2009/04/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090461-001 | LEVETIRACETAM | AJENAT PHARMACEUTICALS LLC | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2010/09/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090601-001 | LEVETIRACETAM | HIKMA PHARMACEUTICALS USA INC | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2012/02/28 | N / N | DISCONTINUED | openFDA ↗ |
| A090893-001 | LEVETIRACETAM | LUPIN LTD | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2011/10/17 | N / N | DISCONTINUED | openFDA ↗ |
| A090992-001 | LEVETIRACETAM | AMNEAL PHARMACEUTICALS | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2009/10/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A201157-001 | LEVETIRACETAM | PHARMACEUTICAL ASSOCIATES INC | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2015/06/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203052-001 | LEVETIRACETAM | HETERO LABS LTD UNIT III | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2013/02/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203067-001 | LEVETIRACETAM | ALEMBIC PHARMACEUTICALS LTD | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2013/05/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214673-001 | LEVETIRACETAM | STRIDES PHARMA GLOBAL PTE LTD | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2023/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A214757-001 | LEVETIRACETAM | MSN LABORATORIES PRIVATE LTD | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2022/07/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218080-001 | LEVETIRACETAM | ADAPTIS PHARMA PRIVATE LTD | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2025/11/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021505-001 | KEPPRA | UCB INC | SOLUTION | ORAL | LEVETIRACETAM: 100MG/ML | 2003/07/15 | Y / Y | 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 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20183245150ml∶15g | 2018/07/06 | Official source ↗ |
| UCB Pharma S.A. | H20160152;H2016015310% | 2011/03/04 | Official source ↗ |
NHSA approval numbers 29
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| UCB Pharma S.A. | 国药准字J2016006010% | — | Official source ↗ |
| Shanghai Mei You Pharmaceutical Co., Ltd. romanized | 国药准字H20253954150ml:15g | — | Official source ↗ |
| Jian Min Group Ye Kai Tai Guo Yao (Sui Zhou) Co., Ltd. romanized | 国药准字H2020316410%(150ml:15g) | — | Official source ↗ |
| Shaanxi Tian Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20253937150ml:15g | — | Official source ↗ |
| Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234120100ml:10g | — | Official source ↗ |
| Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized | 国药准字H20234346150ml:15g | — | Official source ↗ |
| Chang Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20244447150ml:15g | — | Official source ↗ |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20213151150ml:15g(10%) | — | Official source ↗ |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H20193334150ml:15g(10%) | — | Official source ↗ |
| Hunan Jia Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20243965150ml:15g | — | Official source ↗ |
| Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | 国药准字H20253467150ml:15g | — | Official source ↗ |
| Hubei Duo Rui Pharma Co., Ltd. romanized | 国药准字H20255490150ml:15g | — | Official source ↗ |
| Hai Da She Hua Ge Pharma Co., Ltd. romanized | 国药准字H2021333410%(150ml:15g) | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20183245150ml∶15g | — | Official source ↗ |
| Henan Hua Luo Kang Run Pharma Co., Ltd. romanized | 国药准字H20233543100ml:10g | — | Official source ↗ |
| Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20193176150ml:15g | — | Official source ↗ |
| NextPharma SAS | H2016015310% | — | Official source ↗ |
| Hetero Labs Limited | 国药准字HJ20240029300ml:30g | — | Official source ↗ |
| Guangdong He Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20265075150ml:15g | — | Official source ↗ |
| Jilin Si Huan Ao Kang Pharma Co., Ltd. romanized | 国药准字H20255558150ml:15g | — | Official source ↗ |
| Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized | 国药准字H20244954150ml: 15g | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20244796150ml:15g | — | Official source ↗ |
| Beijing Yi Jia Xin Chuang Medical Devices Technology Research Institute Co., Ltd. romanized | 国药准字H20244777100ml:10g | — | Official source ↗ |
| Hefei Dan Bin Ni Pharma Co., Ltd. romanized | 国药准字H20243832150ml:15g | — | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20265792150ml:15g | — | Official source ↗ |
| NextPharma SAS | 国药准字HJ2016015310% | — | Official source ↗ |
| NextPharma SAS | 国药准字HJ2016015210% | — | Official source ↗ |
| Shen Ji (Zhuhai) Pharmaceutical Co., Ltd. romanized | 国药准字H20247224150ml: 15g | — | Official source ↗ |
| Hetero Labs Limited | 国药准字HJ20240028150ml:15g | — | Official source ↗ |
Under review 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602577 | 2026/10/21 | Official source ↗ |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized | CYHS2602072 | 2026/08/20 | Official source ↗ |
| Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized | CYHS2501539 | 2025/04/24 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602577 | 2026/10/21 | Official source ↗ |
| Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized | CYHS2602072 | 2026/08/20 | Official source ↗ |
API companies with A status 28
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Anhui Yue Kang Kai Yue Pharmaceutical Co., Ltd. romanized | Y20230000273 | 2025/02/24 | Official source ↗ |
| Zhejiang Jiang Bei Nan Hai Pharma Co., Ltd. romanized | Y20230000609 | 2026/03/17 | Official source ↗ |
| Jilin Hui Kang Pharmaceutical Co., Ltd. romanized | Y20220000622 | 2024/05/30 | Official source ↗ |
| EXEMED PHARMACEUTICALS | Y20210001275 | 2024/11/21 | Official source ↗ |
| Chieron Active Ingredients Private Limited | Y20210000396 | 2025/10/27 | Official source ↗ |
| Srini Pharmaceuticals Private Limited | Y20200001057 | 2023/05/05 | Official source ↗ |
| Lupin Limited | Y20200000807 | 2026/03/30 | Official source ↗ |
| Wei Fang Shi Hai Xin Pharma Co., Ltd. romanized | Y20200000436 | 2022/10/28 | Official source ↗ |
| Dong Bei Pharmaceutical Group Co., Ltd. romanized | Y20200000328 | 2026/11/03 | Official source ↗ |
| Jilin Sheng Bo Da Pharmaceutical Co., Ltd. romanized | Y20190000808 | 2026/07/13 | Official source ↗ |
| Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190009888 | 2025/01/18 | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20190007590 | 2024/07/24 | Official source ↗ |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | Y20190007418 | 2023/10/11 | Official source ↗ |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized | Y20190002685 | 2024/09/15 | Official source ↗ |
| Hetero Labs Limited | Y20190000323 | 2026/03/31 | Official source ↗ |
| DIVIS LABORATORIES LIMITED | Y20180001576 | 2024/03/14 | Official source ↗ |
| Shang Yu Jing Xin Pharma Co., Ltd. romanized | Y20190000125 | 2024/11/14 | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20180001541 | 2025/09/04 | Official source ↗ |
| Neuland Laboratories Limited | Y20180000007 | 2026/05/20 | Official source ↗ |
| Zhejiang Jiang Bei Pharma Co., Ltd. romanized | Y20180001065 | 2025/11/11 | Official source ↗ |
| Zhejiang Xin Sai Ke Pharma Co., Ltd. romanized | Y20170002318 | 2024/05/28 | Official source ↗ |
| Dr. Reddy’s Laboratories Limited | Y20180000334 | 2025/12/11 | Official source ↗ |
| Lang Fang Gao Bo Jing Bang Pharmaceutical Co., Ltd. romanized | Y20170001734 | 2023/09/26 | Official source ↗ |
| Zhejiang Pu Luo Jia Yuan Pharma Co., Ltd. romanized | Y20170001866 | 2024/08/10 | Official source ↗ |
| Ya Ben Chemical Co., Ltd. romanized | Y20170001304 | 2023/10/20 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20170000952 | 2026/05/20 | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | Y20170000700 | 2025/01/09 | Official source ↗ |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | Y20170000606 | 2024/04/03 | 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 ↗ · 27-389 · 2020/06/04
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Sign in to subscribeYearly
US$1,920
Billed every year
US$160 per month
Sign in to subscribeNeed more than 10 followed products or more than 5 recipients? Contact us.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy