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Sign in to subscribeNimodipine Oral Solution
Matched- Active ingredients (original)
- NIMODIPINE
- 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 approval2013/05/10
ANDA applications2
RLD applicantAZURITY PHARMACEUTICALS INC
Currently marketed products: 3 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A213409-001 | NIMODIPINE | ALKEM LABORATORIES LTD | SOLUTION | ORAL | NIMODIPINE: 6MG/ML | 2025/01/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216937-001 | NIMODIPINE | ANNORA PHARMA PRIVATE LTD | SOLUTION | ORAL | NIMODIPINE: 3MG/ML | 2024/07/09 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N203340-001 | NYMALIZE | AZURITY PHARMACEUTICALS INC | SOLUTION | ORAL | NIMODIPINE: 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2013/05/10 | Y / N | DISCONTINUED | openFDA ↗ |
| N203340-002 | NYMALIZE | AZURITY PHARMACEUTICALS INC | SOLUTION | ORAL | NIMODIPINE: 6MG/ML | 2020/04/08 | 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 expiration2038/04/16
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 |
|---|---|---|---|---|---|---|
| N203340-002 | 10342787 | 2038/04/16 | — / Y | U-2804 | — | openFDA ↗ |
| N203340-002 | 10576070 | 2038/04/16 | — / Y | U-2804 | — | openFDA ↗ |
| N203340-002 | 11207306 | 2038/04/16 | — / — | U-2804 | — | openFDA ↗ |
| N203340-002 | 11413277 | 2038/04/16 | — / Y | U-2804 | — | openFDA ↗ |
| N203340-002 | 11806338 | 2038/04/16 | — / Y | — | — | openFDA ↗ |
| N203340-002 | 12186308 | 2038/04/16 | — / Y | U-2804 | — | openFDA ↗ |
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 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
NHSA approval numbers 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Changzhou Si Yao Pharmaceutical Co., Ltd. romanized | 国药准字H2025493110ml:60mg | — | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 国药准字H2022301420ml:60mg | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H2026617910ml:60mg | — | Official source ↗ |
| Zhejiang Guo Jing Pharma Co., Ltd. romanized | 国药准字H2023447610ml:60mg | — | Official source ↗ |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20253866237ml:1.422g | — | Official source ↗ |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H2024428510ml:60mg | — | Official source ↗ |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 国药准字H2024391320ml:60mg | — | Official source ↗ |
| Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 国药准字H20244290237ml:1.422g | — | Official source ↗ |
| Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 国药准字H2025328910ml:60mg | — | Official source ↗ |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2025400910ml:60mg | — | Official source ↗ |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H2024428510ml:60mg | — | Official source ↗ |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H2025400910ml:60mg | — | Official source ↗ |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H2024428510ml:60mg | — | Official source ↗ |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20254010237ml:1.422g | — | Official source ↗ |
Under review 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized | CYHS2600565 | 2026/02/27 | Official source ↗ |
| Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized | CYHS2600564 | 2026/02/27 | Official source ↗ |
| Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized | CYHS2600251 | 2026/01/22 | Official source ↗ |
| Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized | CYHS2600250 | 2026/01/22 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized | CYHS2600565 | 2026/02/27 | Official source ↗ |
| Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized | CYHS2600564 | 2026/02/27 | Official source ↗ |
| Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized | CYHS2600251 | 2026/01/22 | Official source ↗ |
| Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized | CYHS2600250 | 2026/01/22 | Official source ↗ |
API companies with A status 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20230001169 | 2026/11/08 | Official source ↗ |
| Jiangsu Jiu Xu Pharma Co., Ltd. romanized | Y20210000068 | 2025/10/11 | Official source ↗ |
| Bayer Vital GmbH | Y20200001505 | 2025/12/05 | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009425 | 2025/02/13 | Official source ↗ |
| Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized | Y20190008603 | 2025/06/28 | Official source ↗ |
| Le Sheng Pharma Shijiazhuang Co., Ltd. romanized | Y20190005094 | 2024/12/10 | Official source ↗ |
| Xian Bo Ai Pharmaceutical Co., Ltd. romanized | Y20190004836 | 2025/07/28 | Official source ↗ |
| Henan Ke Lun Pharma Co., Ltd. romanized | Y20190004746 | 2024/11/01 | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | Y20190004586 | 2026/03/31 | Official source ↗ |
| Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized | Y20190001823 | 2025/11/12 | Official source ↗ |
| Zhengzhou Rui Kang Pharmaceutical Co., Ltd. romanized | Y20190001753 | 2024/11/01 | 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.
Formulation crosswalk to SOLUTION / ORAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-028. Chinese Pharmacopoeia general chapter 0123
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 38-35 · 2021/02/23
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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